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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02509026




Registration number
NCT02509026
Ethics application status
Date submitted
21/07/2015
Date registered
27/07/2015
Date last updated
16/06/2020

Titles & IDs
Public title
Etanercept Withdrawal And Retreament Study In Subjects With Nr-ax SpA
Scientific title
A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
Secondary ID [1] 0 0
2015-000541-24
Secondary ID [2] 0 0
B1801381
Universal Trial Number (UTN)
Trial acronym
RE-EMBARK
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spondylitis, Ankylosing 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Etanercept

Experimental: Etanercept - etanercept 50 mg QW


Other interventions: Etanercept
50 mg subcutaneous, once weekly, 24 weeks

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment - Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of >=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawal of Etanercept treatment of 24 weeks in Induction period are reported in this outcome measure.
Timepoint [1] 0 0
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Secondary outcome [1] 0 0
Time to Flare Following Withdrawal of Etanercept Treatment - Participants who experienced ASDAS-ESR level of >=2.1 were defined as being flared. Time to experience flare in participants was defined as time to achieve ASDAS-ESR level of >=2.1 after the withdrawal of Etanercept treatment of 24 weeks in induction period. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr.
Timepoint [1] 0 0
Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64)
Secondary outcome [2] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP.
Timepoint [2] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [3] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP.
Timepoint [3] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [4] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP.
Timepoint [4] 0 0
Week 68, 72, 76
Secondary outcome [5] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP.
Timepoint [5] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [6] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP.
Timepoint [6] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [7] 0 0
Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP.
Timepoint [7] 0 0
Week 68, 72, 76
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from [Bath Ankylosing Spondylitis Functional Index] BASFI) and inflammation (from [Bath Ankylosing Spondylitis Disease Activity Index] BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Timepoint [8] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Timepoint [9] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [10] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Timepoint [10] 0 0
Week 64, 68, 72, 76
Secondary outcome [11] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Timepoint [11] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [12] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Timepoint [12] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [13] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20.
Timepoint [13] 0 0
Week 64, 68, 72, 76
Secondary outcome [14] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Timepoint [14] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [15] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Timepoint [15] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [16] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Timepoint [16] 0 0
Week 64, 68, 72, 76
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Timepoint [17] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [18] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Timepoint [18] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3 - ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40.
Timepoint [19] 0 0
Week 64, 68, 72, 76
Secondary outcome [20] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1 - ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Timepoint [20] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [21] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2 - ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Timepoint [21] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [22] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3 - ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Timepoint [22] 0 0
Week 64, 68, 72, 76
Secondary outcome [23] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1 - ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Timepoint [23] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [24] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2 - ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Timepoint [24] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [25] 0 0
Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3 - ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis.
Timepoint [25] 0 0
Week 64, 68, 72, 76
Secondary outcome [26] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1 - ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [26] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [27] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2 - ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm,where 0= no disease activity and 10= high disease activity.CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [27] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [28] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3 - ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [28] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3: Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [29] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1 - ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [29] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [30] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2 - ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [30] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [31] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3 - ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [31] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [32] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1.
Timepoint [32] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [33] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1.
Timepoint [33] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [34] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1.
Timepoint [34] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [35] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1.
Timepoint [35] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [36] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1.
Timepoint [36] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [37] 0 0
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3 - ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1.
Timepoint [37] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [38] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1 - Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [38] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [39] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2 - Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [39] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [40] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3 - Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [40] 0 0
Week 64, 68, 72, 76
Secondary outcome [41] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1 - Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [41] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [42] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2 - Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [42] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [43] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3 - Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm.
Timepoint [43] 0 0
Week 64, 68, 72, 76
Secondary outcome [44] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1 - ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm.
Timepoint [44] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [45] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2 - ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm.
Timepoint [45] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [46] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3 - ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm.
Timepoint [46] 0 0
Week 64, 68, 72, 76
Secondary outcome [47] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1 - ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm.
Timepoint [47] 0 0
Week 4, 8, 12, 16, 24
Secondary outcome [48] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2 - ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm.
Timepoint [48] 0 0
Week 28, 32, 40, 48, 56, 64
Secondary outcome [49] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3 - ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm.
Timepoint [49] 0 0
Week 64, 68, 72, 76
Secondary outcome [50] 0 0
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1 - Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to centimeter (cm) for analysis.
Timepoint [50] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [51] 0 0
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2 - Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [51] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [52] 0 0
Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3 - Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [52] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [53] 0 0
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1 - Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [53] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [54] 0 0
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2 - Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [54] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [55] 0 0
Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3 - Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [55] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [56] 0 0
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1 - Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [56] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [57] 0 0
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2 - Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [57] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [58] 0 0
Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3 - Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [58] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [59] 0 0
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1 - Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [59] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [60] 0 0
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2 - Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [60] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [61] 0 0
Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3 - Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis.
Timepoint [61] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [62] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1 - BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Timepoint [62] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [63] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2 - BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Timepoint [63] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [64] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3 - BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Timepoint [64] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [65] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1 - BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Timepoint [65] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [66] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2 - BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Timepoint [66] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [67] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3 - BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis.
Timepoint [67] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [68] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1 - BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Timepoint [68] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [69] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2 - BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Timepoint [69] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [70] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3 - BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Timepoint [70] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [71] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1 - BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Timepoint [71] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [72] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2 - BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Timepoint [72] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [73] 0 0
Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3 - BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis.
Timepoint [73] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [74] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1 - 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1).
Timepoint [74] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [75] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2 - 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal).
Timepoint [75] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [76] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3 - 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment).
Timepoint [76] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [77] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1 - 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1).
Timepoint [77] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [78] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2 - 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal).
Timepoint [78] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [79] 0 0
Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3 - 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment).
Timepoint [79] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [80] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1 - Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Timepoint [80] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [81] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2 - Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Timepoint [81] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [82] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3 - Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Timepoint [82] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [83] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1 - Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Timepoint [83] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [84] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2 - Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Timepoint [84] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [85] 0 0
Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3 - Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation.
Timepoint [85] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [86] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1 - The EQ-5D questionnaire is a health-related quality of life assessment (HRQOL). The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. The outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Timepoint [86] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [87] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2 - The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Timepoint [87] 0 0
Week 32, 48, 64
Secondary outcome [88] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Observed Cases (OC): Period 3 - The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Timepoint [88] 0 0
Week 64, 76
Secondary outcome [89] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Timepoint [89] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [90] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Timepoint [90] 0 0
Week 32, 48, 64
Secondary outcome [91] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm.
Timepoint [91] 0 0
Week 64, 76
Secondary outcome [92] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Observed Cases (OC): Period 1 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Timepoint [92] 0 0
Week 12, 24
Secondary outcome [93] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [93] 0 0
Week 32, 48, 64
Secondary outcome [94] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Observed Cases (OC): Period 3 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [94] 0 0
Week 64, 76
Secondary outcome [95] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Timepoint [95] 0 0
Week 12, 24
Secondary outcome [96] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [96] 0 0
Week 32, 48, 64
Secondary outcome [97] 0 0
Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [97] 0 0
Week 64, 76
Secondary outcome [98] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Timepoint [98] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [99] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [99] 0 0
Week 32, 48, 64
Secondary outcome [100] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [100] 0 0
Week 64, 76
Secondary outcome [101] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24.
Timepoint [101] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [102] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [102] 0 0
Week 32, 48, 64
Secondary outcome [103] 0 0
Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [103] 0 0
Week 64, 76
Secondary outcome [104] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [104] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [105] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [105] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [106] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [106] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [107] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [107] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [108] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [108] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [109] 0 0
Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''.
Timepoint [109] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [110] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores (physical component scores [PCS]; mental component scores [MCS]). Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [110] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [111] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [111] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [112] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [112] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [113] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [113] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [114] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [114] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [115] 0 0
Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [115] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [116] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).
Timepoint [116] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [117] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Timepoint [117] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [118] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Timepoint [118] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [119] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).
Timepoint [119] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [120] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Timepoint [120] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [121] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Timepoint [121] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [122] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [122] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [123] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [123] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [124] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [124] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [125] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [125] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [126] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [126] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [127] 0 0
Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value).
Timepoint [127] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [128] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to baseline (Day 1).
Timepoint [128] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [129] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Timepoint [129] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [130] 0 0
Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Timepoint [130] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [131] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1).
Timepoint [131] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [132] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal).
Timepoint [132] 0 0
Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [133] 0 0
Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3 - SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment).
Timepoint [133] 0 0
Period 3 baseline (last visit before retreatment), Week 64, 76
Secondary outcome [134] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1 - The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "ankylosing spondylitis (AS)" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Timepoint [134] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [135] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2 - The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Timepoint [135] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [136] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3 - The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Timepoint [136] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [137] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1 - The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Timepoint [137] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [138] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2 - The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Timepoint [138] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [139] 0 0
Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3 - The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity.
Timepoint [139] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [140] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Last Observation Carried Forward (LOCF): Period 1 - Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Timepoint [140] 0 0
Baseline (Day 1 Week 1), Week 24
Secondary outcome [141] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2 - Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Timepoint [141] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64
Secondary outcome [142] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Timepoint [142] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [143] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Observed Cases (OC): Period 1 - Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Timepoint [143] 0 0
Baseline (Day 1 Week 1), Week 24
Secondary outcome [144] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2 - Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Timepoint [144] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64
Secondary outcome [145] 0 0
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3 - Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease.
Timepoint [145] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [146] 0 0
Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3 - Time to ASDAS inactive disease was defined as the time from first dose of retreatment until the first observed event of ASDAS inactive disease. Inactive disease is defined as an ASDAS score <1.3. for ASDAS-CRP or ASDAS score of >=2.1 for ASDAS-ESR. Participants who did not achieve ASDAS inactive disease were censored at the time of the last ASDAS evaluation in the interval.
Timepoint [146] 0 0
Within 12 weeks of Period 3 (retreatment period from Week 64 to 76)
Secondary outcome [147] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1 - Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [147] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [148] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2 - Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [148] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [149] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3 - Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [149] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [150] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1 - Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [150] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [151] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2 - Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [151] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [152] 0 0
Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3 - Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [152] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [153] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1 - The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [153] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [154] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2 - The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [154] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [155] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3 - The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [155] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [156] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1 - The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [156] 0 0
Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24
Secondary outcome [157] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2 - The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [157] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64
Secondary outcome [158] 0 0
Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3 - The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes.
Timepoint [158] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76
Secondary outcome [159] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Timepoint [159] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [160] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Timepoint [160] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [161] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Timepoint [161] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [162] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1 - The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Timepoint [162] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [163] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2 - The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Timepoint [163] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [164] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3 - The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition.
Timepoint [164] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [165] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1 - Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Timepoint [165] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [166] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2 - Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Timepoint [166] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [167] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3 - Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Timepoint [167] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [168] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Timepoint [168] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [169] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Timepoint [169] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [170] 0 0
Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3 - Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1.
Timepoint [170] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [171] 0 0
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1 - Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Timepoint [171] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [172] 0 0
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2 - Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Timepoint [172] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [173] 0 0
Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3 - Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Timepoint [173] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [174] 0 0
Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Timepoint [174] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [175] 0 0
Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Timepoint [175] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [176] 0 0
Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1.
Timepoint [176] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [177] 0 0
Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1 - Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Timepoint [177] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [178] 0 0
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2 - Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Timepoint [178] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [179] 0 0
Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3 - Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Timepoint [179] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [180] 0 0
Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Timepoint [180] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [181] 0 0
Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Timepoint [181] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [182] 0 0
Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation.
Timepoint [182] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [183] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1 - The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Timepoint [183] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [184] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2 - The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Timepoint [184] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [185] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3 - The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Timepoint [185] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [186] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 - The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Timepoint [186] 0 0
Baseline (Day 1 Week 1), Week 12, 24
Secondary outcome [187] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 - The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Timepoint [187] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2: Baseline (last visit before treatment withdrawal), Week 32, 48, 64
Secondary outcome [188] 0 0
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 - The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses.
Timepoint [188] 0 0
Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76
Secondary outcome [189] 0 0
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) - An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state.
Timepoint [189] 0 0
Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks)

Eligibility
Key inclusion criteria
- diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a
less than favorable response to NSAIDs
Minimum age
18 Years
Maximum age
49 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- radiological sacroiliitis previous treatment with TNF inhibitor, biologic,
immunosuppressive

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA
Recruitment hospital [1] 0 0
Genesis Research Services Pty Ltd - Broadmeadow
Recruitment hospital [2] 0 0
Hunter Imaging Group - Cardiff
Recruitment hospital [3] 0 0
Pacific Radiology - Maroochydore
Recruitment hospital [4] 0 0
Rheumatology Research Centre - Maroochydore
Recruitment hospital [5] 0 0
Benson Radiology - North Adelaide
Recruitment hospital [6] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [7] 0 0
SKG Radiology Hollywood Hospital - Nedlands
Recruitment hospital [8] 0 0
SKG Radiology Subiaco - Subiaco
Recruitment hospital [9] 0 0
R.K. Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
2292 - Broadmeadow
Recruitment postcode(s) [2] 0 0
2285 - Cardiff
Recruitment postcode(s) [3] 0 0
4558 - Maroochydore
Recruitment postcode(s) [4] 0 0
5006 - North Adelaide
Recruitment postcode(s) [5] 0 0
5011 - Woodville South
Recruitment postcode(s) [6] 0 0
6009 - Nedlands
Recruitment postcode(s) [7] 0 0
6008 - Subiaco
Recruitment postcode(s) [8] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Illinois
Country [3] 0 0
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Oregon
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Belgium
State/province [7] 0 0
OVL
Country [8] 0 0
Belgium
State/province [8] 0 0
Genk
Country [9] 0 0
Colombia
State/province [9] 0 0
Antioquia
Country [10] 0 0
Colombia
State/province [10] 0 0
Cundinamarca
Country [11] 0 0
Czechia
State/province [11] 0 0
Praha 11
Country [12] 0 0
Czechia
State/province [12] 0 0
Praha 2
Country [13] 0 0
Czechia
State/province [13] 0 0
Uherske Hradiste
Country [14] 0 0
Finland
State/province [14] 0 0
Helsinki
Country [15] 0 0
Finland
State/province [15] 0 0
Hyvinkaa
Country [16] 0 0
France
State/province [16] 0 0
Nancy
Country [17] 0 0
France
State/province [17] 0 0
Paris
Country [18] 0 0
France
State/province [18] 0 0
Rennes
Country [19] 0 0
France
State/province [19] 0 0
Toulouse cedex 9
Country [20] 0 0
France
State/province [20] 0 0
Vandoeuvre les Nancy
Country [21] 0 0
France
State/province [21] 0 0
Vandoeuvre-les-Nancy cedex
Country [22] 0 0
Germany
State/province [22] 0 0
Bavaria
Country [23] 0 0
Germany
State/province [23] 0 0
NRW
Country [24] 0 0
Germany
State/province [24] 0 0
Berlin
Country [25] 0 0
Germany
State/province [25] 0 0
Chemnitz
Country [26] 0 0
Germany
State/province [26] 0 0
Koeln
Country [27] 0 0
Hungary
State/province [27] 0 0
Budapest
Country [28] 0 0
Hungary
State/province [28] 0 0
Veszprem
Country [29] 0 0
Netherlands
State/province [29] 0 0
Amsterdam
Country [30] 0 0
Netherlands
State/province [30] 0 0
Leiden
Country [31] 0 0
Poland
State/province [31] 0 0
Bydgoszcz
Country [32] 0 0
Poland
State/province [32] 0 0
Elblag
Country [33] 0 0
Poland
State/province [33] 0 0
Koscian
Country [34] 0 0
Poland
State/province [34] 0 0
Lublin
Country [35] 0 0
Poland
State/province [35] 0 0
Nowy Duninow
Country [36] 0 0
Poland
State/province [36] 0 0
Poznan
Country [37] 0 0
Poland
State/province [37] 0 0
Sochaczew
Country [38] 0 0
Poland
State/province [38] 0 0
Stalowa Wola
Country [39] 0 0
Poland
State/province [39] 0 0
Torun
Country [40] 0 0
Poland
State/province [40] 0 0
Warszawa
Country [41] 0 0
Poland
State/province [41] 0 0
Wroclaw
Country [42] 0 0
Spain
State/province [42] 0 0
A Coruna
Country [43] 0 0
Spain
State/province [43] 0 0
Santa CRUZ DE Tenerife
Country [44] 0 0
Spain
State/province [44] 0 0
La Coruna
Country [45] 0 0
Spain
State/province [45] 0 0
Sevilla
Country [46] 0 0
Sweden
State/province [46] 0 0
Gothenburg
Country [47] 0 0
Sweden
State/province [47] 0 0
Malmo
Country [48] 0 0
Sweden
State/province [48] 0 0
Uppsala
Country [49] 0 0
Taiwan
State/province [49] 0 0
Kaohsiung
Country [50] 0 0
Taiwan
State/province [50] 0 0
Taichung

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to study the benefits and risks of etanercept withdrawal in
patients who have achieved a significant clinical response.
Trial website
https://clinicaltrials.gov/show/NCT02509026
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications