Please note the ANZCTR will be unattended from Friday 20 December 2019 for the holidays. The Registry will re-open on Tuesday 07 January 2020. Submissions and updates will not be processed during that time.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02407223




Registration number
NCT02407223
Ethics application status
Date submitted
30/03/2015
Date registered
2/04/2015
Date last updated
13/03/2019

Titles & IDs
Public title
An Efficacy and Safety Study of Ustekinumab in Participants With Active Nonradiographic Axial Spondyloarthritis
Scientific title
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Ustekinumab in the Treatment of Subjects With Active Nonradiographic Axial Spondyloarthritis
Secondary ID [1] 0 0
CNTO1275AKS3003
Secondary ID [2] 0 0
CR106995
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonradiographic Axial 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
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Group 1: Placebo
Treatment: Drugs - Group 2: Ustekinumab 45 mg
Treatment: Drugs - Group 3: Ustekinumab 90 mg

Placebo Comparator: Group 1: Placebo - Participants will receive placebo subcutaneously (SC) at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 milligram (mg) SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88. NOTE: Intervention Description should have no more than 800 characters.

Experimental: Group 2: Ustekinumab 45 milligram (mg) - Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.

Experimental: Group 3: Ustekinumab 90 mg - Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.


Treatment: Drugs: Group 1: Placebo
Participants will receive placebo SC at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 mg SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.

Treatment: Drugs: Group 2: Ustekinumab 45 mg
Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.

Treatment: Drugs: Group 3: Ustekinumab 90 mg
Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved Assessment of SpondyloArthritis International Society (ASAS) 20 Response at Week 24 - ASAS 20 defined as improvement of greater than or equal to (>=) 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 centimeter(cm) scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Percentage of Participants Who Achieved an ASAS 40 Response at Week 24 - ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor),total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10 cm; 0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 - The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness were added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in response based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 - The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of ankylosing spondylitis participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing).
Timepoint [3] 0 0
Baseline, Week 24
Secondary outcome [4] 0 0
Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-reactive Protein (CRP) Inactive Disease (<1.3) at Week 24 - ASDAS includes CRP milligram per liter (mg/L); four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).
Timepoint [4] 0 0
Week 24
Secondary outcome [5] 0 0
Change From Baseline in High Sensitivity C-Reactive Protein (hsCRP) Levels Through Week 24 - Change from baseline in hsCRP levels was reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. Early escape rule was applied (measurement value at Week 20 and Week 24 was set as missing). Here 'n' signifies the number of participants who were analyzed at each specified timepoints, for each arm, respectively.
Timepoint [5] 0 0
Baseline, Week 4, 8, 12, 16, 20 and 24
Secondary outcome [6] 0 0
Percentage of Participants With ASAS 20 Components at Week 24 - ASAS 20 defined as >= 20% improvement from baseline in 4 individual components of ASAS20: Patient's global assessment (PGA) of disease activity (0 to 10cm; 0=very well,10=very poor), total back pain(0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean(0 to10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to functional anatomy and 2 relate to participant's ability to cope with life) and Inflammation (0 to 10cm;0=none,10=very severe).
Timepoint [6] 0 0
Week 24
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ASAS 40 Response at Week 4, 8, 12, 16 and 20 - ASAS 40 defined as improvement of >= 40% from baseline and absolute improvement from baseline of at least 2 on 0 to10cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10cm; 0=very well,10=very poor),total back pain (0 to 10cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 relate to participant's ability to cope with everyday life), Inflammation (0 to 10cm;0=none,10=very severe); no worsening at all from baseline in remaining domain. ASAS40 response based on imputed data using treatment failure (consider non-responders at and after treatment failure), early escape rules(consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Timepoint [7] 0 0
Week 4, 8, 12, 16 and 20
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ASAS 20 Response at Week 4, 8, 12, 16 and 20 - ASAS 20 defined as improvement of >= 20 % from baseline and absolute improvement from baseline of 1 on a 0 to 10 cm scale in at least 3 of following 4 domains: Patient's global assessment of disease activity (0 to 10 cm; 0=very well,10=very poor), total back pain (0 to 10 cm; 0=no pain,10=most severe pain), BASFI (self-assessment represented as mean (0 to 10 cm; 0=easy to 10=impossible) of 10 questions, 8 of which relate to participant's functional anatomy and 2 to participant's ability to cope with everyday life), Inflammation (0 to 10 cm;0=none,10=very severe); absence of deterioration (>= 20% and worsening of at least 1 on a 0 to 10 cm scale) from baseline in remaining domain. ASAS20 response based on imputed data using treatment failure (consider non-responders at and after treatment failure),early escape rules (consider non-responder at Week 20 and 24),non-responder[NRI] (missing responses at post baseline visit imputed as non-responder).
Timepoint [8] 0 0
Week 4, 8, 12, 16 and 20
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved at Least a 50% Improvement From Baseline in BASDAI at Week 4, 8, 12, 16 and 20 - The BASDAI is used to measure the ankylosing spondylitis (AS) disease severity. It consists of 6 questions: fatigue, spinal pain, arthralgia (joint pain) or swelling, enthesitis (inflammation of tendons and ligaments), and morning stiffness (2 questions: duration and severity). Each question is an easy to answer 10 centimeter (cm) visual analog scale (VAS), with 0 being none, and 10 being very severe. In order to give each of the 5 symptoms equal weight, the mean of the 2 questions about morning stiffness will be added to the total of the remaining 4 scores, and the final BASDAI score (ranging 0-10) is the average of the overall total score. Higher BASDAI score indicates more severe AS symptom. 50% improvement in BASDAI based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI(missing responses at post baseline visit imputed as non-responders).
Timepoint [9] 0 0
Week 4, 8, 12, 16, and 20
Secondary outcome [10] 0 0
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 4, 8, 12, 16 and 20 - The BASFI is composed with 10 questions (each question is answered with a visual analogue scale 0-10 cm) to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Each question is a 10cm VAS with a value between 0 (easy) and 10 (impossible). The final BASFI score is the mean of the 10 scores. The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10. Higher BASFI score indicates more severe functional limitations of the participant due to AS. Missing data were imputed using early escape rule (measurement value at Week 20 and 24 was set as missing). Here 'n' defined as number of participants who were analyzed at each specified timepoint, for each arm, respectively.
Timepoint [10] 0 0
Baseline, Week 4, 8, 12, 16 and 20
Secondary outcome [11] 0 0
Percentage of Participants With ASDAS (CRP) Inactive Disease (<1.3) at Week 4, 8, 12, 16, and 20 - ASDAS includes CRP mg/L; four additional self-reported items (rated on 0-10cm VAS or 0-10 numerical rating scale [NRS]) included total back pain(TBP), duration of morning stiffness (DMS), peripheral pain/swelling and patient global assessment(PGA). ASDAS scores calculated as: ASDAS(CRP) = (0.121*total back pain)+ (0.110*PGA)+ (0.073*peripheral pain/swelling)+ (0.058* DMS)+ (0.579*Ln(CRP+1)). The disease activity, TBP, and peripheral pain/swelling on a numeric rating scale (from 0 (normal) to 10 (very severe)) and DMS on a numeric rating scale (0 to 10, with 0 being none and 10 representing a duration of =>2 hours). Inactive disease is defined as an ASDAS score <1.3. ASDAS (CRP) Inactive Disease is based on imputed data using treatment failure(consider non-responders at and after treatment failure),early escape rules(consider non-responder at Week 20 and 24), NRI (missing responses at post baseline visit imputed as non-responder).
Timepoint [11] 0 0
Week 4, 8, 12, 16, and 20

Eligibility
Key inclusion criteria
- Participants must be classified as having nonradiographic axial spondyloarthritis
(nr-AxSpA) based on 2009 Assessment of SpondyloArthritis International Society (ASAS)
criteria

- Must have an age at nr-AxSpA onset of <= 45 years

- Must have at screening or active inflammation on magnetic resonance imaging (MRI) as
evidenced by the central readers and no radiographic sacroiliitis that fulfills the
1984 modified New York Criteria

- Must have symptoms of active disease at screening and at baseline, as evidenced by
both a BASDAI score of >= 4 and a visual analogue scale (VAS) score for total back
pain of more than or equal to (>=) 4, each on a scale of 0 to 10
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Have radiographic sacroiliitis fulfilling the 1984 modified New York Criteria

- Have other inflammatory diseases that might confound the evaluations of benefit from
the ustekinumab therapy

- Have received any systemic immunosuppressives or disease-modifying anti-rheumatic drug
(DMARDs) other than methotrexate (MTX), sulfasalazine (SSZ), or hydroxychloroquine
(HCQ) within 4 weeks prior to first administration of study agent

- Have received epidural, intra-articular, intramuscular (IM), or intravenous (IV)
corticosteroids, including adrenocorticotropic hormone during the 4 weeks prior to
first administration of study agent

- Have received prior biologic therapy other than anti-TNFa

- Have received more than 1 prior anti-TNFa agent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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)
Recruitment hospital [1] 0 0
- Geelong
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Kogarah
Recruitment hospital [4] 0 0
- Queensland
Recruitment hospital [5] 0 0
- Woodville South
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment postcode(s) [1] 0 0
- Geelong
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Kogarah
Recruitment postcode(s) [4] 0 0
- Queensland
Recruitment postcode(s) [5] 0 0
- Woodville South
Recruitment postcode(s) [6] 0 0
- Woolloongabba
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Ciudad De Buenos Aires
Country [3] 0 0
Argentina
State/province [3] 0 0
Ciudad De La Plata
Country [4] 0 0
Argentina
State/province [4] 0 0
Ciudad De San Miguel De Tucuman
Country [5] 0 0
Argentina
State/province [5] 0 0
Cordoba
Country [6] 0 0
Belgium
State/province [6] 0 0
Genk
Country [7] 0 0
Belgium
State/province [7] 0 0
Gent
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Belgium
State/province [9] 0 0
Liège
Country [10] 0 0
Belgium
State/province [10] 0 0
Merksem
Country [11] 0 0
Czechia
State/province [11] 0 0
Brno
Country [12] 0 0
Czechia
State/province [12] 0 0
Bruntal
Country [13] 0 0
Czechia
State/province [13] 0 0
Kladno
Country [14] 0 0
Czechia
State/province [14] 0 0
Ostrava
Country [15] 0 0
Czechia
State/province [15] 0 0
Pardubice
Country [16] 0 0
Czechia
State/province [16] 0 0
Prague 5
Country [17] 0 0
Czechia
State/province [17] 0 0
Praha 2
Country [18] 0 0
Czechia
State/province [18] 0 0
Praha 4
Country [19] 0 0
Czechia
State/province [19] 0 0
Uherske Hradiste
Country [20] 0 0
Czechia
State/province [20] 0 0
Zlin
Country [21] 0 0
France
State/province [21] 0 0
Boulogne-Billancourt
Country [22] 0 0
France
State/province [22] 0 0
Chambray Les Tours
Country [23] 0 0
France
State/province [23] 0 0
Echirolles
Country [24] 0 0
France
State/province [24] 0 0
Montpellier, Herault
Country [25] 0 0
France
State/province [25] 0 0
Paris
Country [26] 0 0
France
State/province [26] 0 0
Toulouse
Country [27] 0 0
Germany
State/province [27] 0 0
Bad Nauheim
Country [28] 0 0
Germany
State/province [28] 0 0
Berlin
Country [29] 0 0
Germany
State/province [29] 0 0
Hamburg
Country [30] 0 0
Germany
State/province [30] 0 0
Hannover
Country [31] 0 0
Germany
State/province [31] 0 0
Herne
Country [32] 0 0
Germany
State/province [32] 0 0
Köln
Country [33] 0 0
Germany
State/province [33] 0 0
Olsberg
Country [34] 0 0
Hungary
State/province [34] 0 0
Budapest
Country [35] 0 0
Hungary
State/province [35] 0 0
Debrecen
Country [36] 0 0
Hungary
State/province [36] 0 0
Esztergom
Country [37] 0 0
Hungary
State/province [37] 0 0
Kistarcsa
Country [38] 0 0
Hungary
State/province [38] 0 0
Nyíregyháza
Country [39] 0 0
Hungary
State/province [39] 0 0
Szolnok
Country [40] 0 0
Hungary
State/province [40] 0 0
Székesfehérvár
Country [41] 0 0
Hungary
State/province [41] 0 0
Veszprem
Country [42] 0 0
Korea, Republic of
State/province [42] 0 0
Gwangju
Country [43] 0 0
Korea, Republic of
State/province [43] 0 0
Incheon
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Seoul
Country [45] 0 0
Mexico
State/province [45] 0 0
Chihuahua
Country [46] 0 0
Mexico
State/province [46] 0 0
Culiacan
Country [47] 0 0
Mexico
State/province [47] 0 0
Guadalajara
Country [48] 0 0
Mexico
State/province [48] 0 0
Mexico
Country [49] 0 0
Poland
State/province [49] 0 0
Bydgoszcz
Country [50] 0 0
Poland
State/province [50] 0 0
Szczecin
Country [51] 0 0
Poland
State/province [51] 0 0
Torun
Country [52] 0 0
Poland
State/province [52] 0 0
Warszawa
Country [53] 0 0
Poland
State/province [53] 0 0
Wroclaw
Country [54] 0 0
Russian Federation
State/province [54] 0 0
Chelyabinsk
Country [55] 0 0
Russian Federation
State/province [55] 0 0
Chita
Country [56] 0 0
Russian Federation
State/province [56] 0 0
Kemerovo
Country [57] 0 0
Russian Federation
State/province [57] 0 0
Kirov
Country [58] 0 0
Russian Federation
State/province [58] 0 0
Moscow
Country [59] 0 0
Russian Federation
State/province [59] 0 0
Novosibirsk
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Orenburg
Country [61] 0 0
Russian Federation
State/province [61] 0 0
Petrozavodsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Sankt-Petersburg.
Country [63] 0 0
Russian Federation
State/province [63] 0 0
Saratov
Country [64] 0 0
Russian Federation
State/province [64] 0 0
St.Petersburg
Country [65] 0 0
Russian Federation
State/province [65] 0 0
Stavropol
Country [66] 0 0
Russian Federation
State/province [66] 0 0
Ulyanovsk
Country [67] 0 0
Russian Federation
State/province [67] 0 0
Zelenograd
Country [68] 0 0
Taiwan
State/province [68] 0 0
Kaohsiung
Country [69] 0 0
Taiwan
State/province [69] 0 0
Taichung
Country [70] 0 0
Taiwan
State/province [70] 0 0
Tainan
Country [71] 0 0
Taiwan
State/province [71] 0 0
Taipei
Country [72] 0 0
Taiwan
State/province [72] 0 0
Taoyuan
Country [73] 0 0
Ukraine
State/province [73] 0 0
Ivano-Frankivsk
Country [74] 0 0
Ukraine
State/province [74] 0 0
Kharkiv
Country [75] 0 0
Ukraine
State/province [75] 0 0
Kyiv
Country [76] 0 0
Ukraine
State/province [76] 0 0
Lviv
Country [77] 0 0
Ukraine
State/province [77] 0 0
Odessa
Country [78] 0 0
Ukraine
State/province [78] 0 0
Ternopil
Country [79] 0 0
Ukraine
State/province [79] 0 0
Vinnytsya
Country [80] 0 0
Ukraine
State/province [80] 0 0
Zaporizhzhya
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Bath
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Leeds
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Leytonstone
Country [84] 0 0
United Kingdom
State/province [84] 0 0
London
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Norwich
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Staffordshire
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Janssen Research & Development, LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the efficacy and safety of ustekinumab in adult
participants with active nonradiographic axial spondyloarthritis (nr-AxSpA) measured by the
reduction in signs and symptoms of nonradiographic axial spondyloarthritis (nr-AxSpA).
Trial website
https://clinicaltrials.gov/show/NCT02407223
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janssen Research & Development, LLC Clinical Trial
Address 0 0
Janssen Research & Development, LLC
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
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02407223