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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02480153




Registration number
NCT02480153
Ethics application status
Date submitted
19/06/2015
Date registered
24/06/2015
Date last updated
23/01/2019

Titles & IDs
Public title
A Study Of PF-06410293 (Adalimumab-Pfizer) And Adalimumab (Humira®) In Combination With Methotrexate In Subjects With Active Rheumatoid Arthritis (REFLECTIONS B538-02).
Scientific title
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY ASSESSING THE EFFICACY AND SAFETY OF PF-06410293 AND ADALIMUMAB IN COMBINATION WITH METHOTREXATE IN SUBJECTS WITH MODERATELY TO SEVERELY ACTIVE RHEUMATOID ARTHRITIS WHO HAVE HAD AN INADEQUATE RESPONSE TO METHOTREXATE
Secondary ID [1] 0 0
B5381002, REFLECTIONS B538-02
Secondary ID [2] 0 0
B5381002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Inflammatory and Immune System 0 0 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - PF-06410293
Other interventions - Adalimumab

Experimental: PF-06410293 -

Active Comparator: Adalimumab -


Other interventions: PF-06410293
PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

Other interventions: Adalimumab
Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1 - ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [1] 0 0
Week 12
Secondary outcome [1] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1 - ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [1] 0 0
Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)
Secondary outcome [2] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2 - ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [2] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [3] 0 0
Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3 - ACR20 is a categorical variable indicating a 20% or greater improvement in tender and swollen joint counts and 20% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [3] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [4] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1 - ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [4] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [5] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2 - ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [5] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [6] 0 0
Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3 - ACR50 is a categorical variable indicating a 50% or greater improvement in tender and swollen joint counts and 50% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [6] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [7] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1 - ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [7] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [8] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2 - ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [8] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [9] 0 0
Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3 - ACR70 is a categorical variable indicating a 70% or greater improvement in tender and swollen joint counts and 70% or greater improvement in 3 of the 5 other ACR-core set measures: patient's assessment of arthritis pain (PAAP); patient's global assessment of arthritis (PGA); physician's global assessment of arthritis (PGAA); high sensitivity C-reactive protein (hs-CRP); and Health Assessment Questionnaire - Disability Index (HAQ-DI).
Timepoint [9] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [10] 0 0
Change From Baseline in Tender Joint Count: Period 1 - Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).
Timepoint [10] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [11] 0 0
Change From Baseline in Tender Joint Count: Period 2 - Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).
Timepoint [11] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [12] 0 0
Change From Baseline in Tender Joint Count: Period 3 - Sixty-eight (68) joints were assessed by an independent blinded joint assessor to determine the number of joints that were considered tender. The 68 joints assessed were: upper body including temporomandibular, sternoclavicular, acromioclavicular; upper extremity including shoulder, elbow, wrist (radiocarpal, carpal and carpometacarpal considered as 1 unit), metacarpophalangeals (MCP I, II, III, IV, V), thumb interphalangeal, proximal interphalangeals (PIP II, III, IV, V), and distal interphalangeals (DIP II, III, IV, V); lower extremity including hip, knee, ankle, tarsus (subtalar, transverse tarsal and tarsometatarsal considered as 1 unit), metatarsophalangeals (MTP I, II, III, IV, V), great toe interphalangeal, proximal and distal interphalangeals combined (PIP and DIP II, III, IV, V).
Timepoint [12] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [13] 0 0
Change From Baseline in Swollen Joint Count: Period 1 - Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
Timepoint [13] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [14] 0 0
Change From Baseline in Swollen Joint Count: Period 2 - Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
Timepoint [14] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [15] 0 0
Change From Baseline in Swollen Joint Count: Period 3 - Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
Timepoint [15] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [16] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1 - The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".
Timepoint [16] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [17] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2 - The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".
Timepoint [17] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [18] 0 0
Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3 - The investigator assessed how the participant's overall arthritis appeared at the time of the visit. This was an evaluation based on the participant's disease symptoms, functional capacity and physical examination, and independent of the participant's reported assessments of PGA (patient's global assessment of arthritis) and PAAP (patient's assessment of arthritis pain). The investigator's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "None" and the 100 mm end labeled "Extreme".
Timepoint [18] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [19] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1 - Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Timepoint [19] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [20] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2 - Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Timepoint [20] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [21] 0 0
Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3 - Participants assessed the severity of their arthritis pain using a 100 mm Visual Analog Scale (VAS) by placing a mark on the scale between 0 (no pain) and 100 (most severe pain), which corresponded to the magnitude of their pain.
Timepoint [21] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [22] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1 - Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".
Timepoint [22] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [23] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2 - Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".
Timepoint [23] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [24] 0 0
Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3 - Participants answered the following question, "Considering all the ways your arthritis affects you, how are you feeling today?" The participant's response was recorded using a 100 mm visual analog scale (VAS), with the 0 mm end labeled "Very Well" and the 100 mm end labeled "Very Poorly".
Timepoint [24] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [25] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1 - HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.
Timepoint [25] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [26] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2 - HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.
Timepoint [26] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [27] 0 0
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3 - HAQ-DI assesses the degree of difficulty a participant had experienced during the past week in 8 domains of daily activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip and other activities. Each activity category consisted of 2-3 items. For each question in the questionnaire, the level of difficulty was scored from 0 to 3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Any activity that required assistance from another individual or required the use of an assistive device would adjust to a minimum score of 2 to represent a more limited functional status. Overall score was computed as the sum of scores divided by the number of domains answered. Total possible score range was 0-3 with 0 representing "no difficulty", 1 as "some difficulty", 2 as "much difficulty", and 3 as "unable to do". Higher score indicate more difficulty in performing daily living activities.
Timepoint [27] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [28] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1 - Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
Timepoint [28] 0 0
Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [29] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2 - Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
Timepoint [29] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [30] 0 0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3 - Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
Timepoint [30] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [31] 0 0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 1 - The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
Timepoint [31] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [32] 0 0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2 - The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
Timepoint [32] 0 0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [33] 0 0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 3 - The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. Higher score indicate more disease activity. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L).
Timepoint [33] 0 0
Baseline, Weeks 52, 56, 66, 76 and 78
Secondary outcome [34] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1 - EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.
Timepoint [34] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [35] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2 - EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.
Timepoint [35] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [36] 0 0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3 - EULAR response was based on DAS28 EULAR response criteria. Good response was achieved if DAS28 improvement from baseline >1.2 and DAS28 =<3.2. Moderate response was achieved if DAS28 improvement from baseline >0.6 to =<1.2 and DAS28 =<5.1; or DAS improvement from baseline >1.2 and DAS28 >3.2. No response was achieved if DAS improvement from baseline =<0.6 (no matter present DAS28 score); or DAS improvement from baseline >0.6 to =<1.2 and DAS28 >5.1.
Timepoint [36] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [37] 0 0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1 - The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.
Timepoint [37] 0 0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [38] 0 0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2 - The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.
Timepoint [38] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [39] 0 0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3 - The DAS assessment is a continuous composite measure derived using differential weighting given to each component. The components of the DAS28-4 (CRP) assessment included: tender joint count with 28 joints assessed, swollen joint count with 28 joints assessed, high-sensitivity C-reactive protein (hs-CRP) and patient's global assessment of arthritis (PGA). DAS28-4 (CRP) was calculated as 0.56 sqrt (DAS 28 tender joint count) + 0.28 sqrt (DAS 28 swollen joint count) + 0.36 ln(CRP [mg/L] +1) + 0.014 (PGA [mm]) + 0.96. The possible lowest score is 0.96. The possible highest score is difficult to be determined, due to indeterminable nature of hs-CRP level; assuming hs-CRP level is 0 to 500 mg/L, the possible highest score would be 6.8 (when hs-CRP is 0) to 9.04 (when hs-CRP is 500 mg/L). Higher score indicate more disease activity; DAS28-4 (CRP) <2.6 indicates remission.
Timepoint [39] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [40] 0 0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response:Period 1 - Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).
Timepoint [40] 0 0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Secondary outcome [41] 0 0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2 - Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).
Timepoint [41] 0 0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Secondary outcome [42] 0 0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3 - Participants were considered to be in ACR/EULAR remission when either of the following criteria was met: scores on the tender joint count, swollen joint count, hs-CRP (mg/dL) and PGA (0-10 cm scale) were all =<1; or the score on the simplified disease activity index (SDAI) was =<3.3. SDAI score was the sum of tender joint count (28), swollen joint count (28), PGA (0-10 cm scale), physician's global assessment of arthritis (PGAA, 0-10 cm scale) and hs-CRP (mg/dL).
Timepoint [42] 0 0
Weeks 52, 56, 66, 76 and 78
Secondary outcome [43] 0 0
Serum Concentration Versus Time Summary: Period 1
Timepoint [43] 0 0
Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit
Secondary outcome [44] 0 0
Serum Concentration Versus Time Summary: Period 2
Timepoint [44] 0 0
Pre-dose on Days 183, 211, 253 and 365
Secondary outcome [45] 0 0
Serum Concentration Versus Time Summary: Period 3
Timepoint [45] 0 0
Pre-dose on Days 365, 393, 463, 547 and 575
Secondary outcome [46] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1 - Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.
Timepoint [46] 0 0
Baseline up to Week 26 (pre-dose)
Secondary outcome [47] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2 - Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.
Timepoint [47] 0 0
Week 26 dosing up to Week 52 (pre-dose)
Secondary outcome [48] 0 0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3 - Serum samples were analyzed for the presence or absence of ADA using a semi-quantitative electrochemiluminescent (ECL) assay, and ADA positive was defined as ADA titer >=1.88. Serum samples tested positive for ADA were further analyzed for the presence or absence of NAb using a semi-quantitative cell-based assay, and NAb positive was defined as NAb titer >=0.70.
Timepoint [48] 0 0
Week 52 dosing up to follow-up visit (Week 92)
Secondary outcome [49] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1 - An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent AEs for Period 1 were events between first dose of study drug in Period 1 and up to Week 26 pre-dose assessments that were absent before treatment or that worsened relative to pre-treatment state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.
Timepoint [49] 0 0
Baseline (Day 1) up to Week 26 (pre-dose)
Secondary outcome [50] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2 - An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent AEs for Period 2 were events between first dose of study drug in Period 2 and up to Week 52 pre-dose assessments that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.
Timepoint [50] 0 0
Week 26 dosing up to Week 52 (pre-dose)
Secondary outcome [51] 0 0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3 - An AE was any untoward medical occurrence in a participant who received study drug 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. Treatment-emergent AEs for Period 3 were events between first dose of study drug in Period 3 and up to Week 92 visit that were absent before treatment or that worsened relative to prior state. Treatment-related TEAE was any untoward medical occurrence attributed to study drug. AEs included both serious and non-serious AEs.
Timepoint [51] 0 0
Week 52 dosing up to follow-up visit (Week 92)
Secondary outcome [52] 0 0
Number of Participants With Laboratory Abnormalities: Period 1 - Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 1 (without regard to baseline abnormality) is presented.
Timepoint [52] 0 0
Baseline (Day 1) up to Week 26 (pre-dose)
Secondary outcome [53] 0 0
Number of Participants With Laboratory Abnormalities: Period 2 - Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 2 (without regard to baseline abnormality) is presented.
Timepoint [53] 0 0
Week 26 dosing up to Week 52 (pre-dose)
Secondary outcome [54] 0 0
Number of Participants With Laboratory Abnormalities: Period 3 - Laboratory evaluation included hematology, clinical chemistry, and urinalysis. Each parameter was evaluated against commonly used and widely accepted criteria. Number of participants with any laboratory abnormality during Period 3 (without regard to baseline abnormality) is presented.
Timepoint [54] 0 0
Week 52 dosing up to follow-up visit (Week 92)

Eligibility
Key inclusion criteria
- Diagnosis of rheumatoid arthritis based on 2010 ACR/EULAR criteria for at least 4
months.

- At least 6 tender (of 68 assessed) and 6 swollen (of 66 assessed) joints at screening
and baseline.

- Hs-CRP equal or greater than 8 mg/L.

- Must have received methotrexate for at least 12 weeks and been on a stable dose for at
least 4 weeks prior to the first study dose.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of untreated or inadequately treated latent or active TB.

- Evidence of uncontrolled, clinically significant diseases, including moderate or
severe heart failure (NYHA Class III/IV) or malignancy in the previous 5 years.

- History of infection requiring hospitalization or parenteral antimicrobial therapy
within 6 months prior to first dose of study drug.

- May have received no more than 2 doses of one biologic therapy (other than adalimumab
or lymphocyte depleting therapy).

- Any second DMARD must be washed out prior to the first study dose.

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 administering the treatment/s
The people assessing the outcomes
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
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)
QLD,SA,WA
Recruitment hospital [1] 0 0
Paradise Arthritis & Rheumatology Pty Ltd - Southport
Recruitment hospital [2] 0 0
The Queen Elizabeth Hospital - Woodville South
Recruitment hospital [3] 0 0
RK Will Pty Ltd - Victoria Park
Recruitment postcode(s) [1] 0 0
4215 - Southport
Recruitment postcode(s) [2] 0 0
5011 - Woodville South
Recruitment postcode(s) [3] 0 0
6100 - Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Iowa
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Mississippi
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
New Jersey
Country [13] 0 0
United States of America
State/province [13] 0 0
New York
Country [14] 0 0
United States of America
State/province [14] 0 0
North Carolina
Country [15] 0 0
United States of America
State/province [15] 0 0
Ohio
Country [16] 0 0
United States of America
State/province [16] 0 0
Pennsylvania
Country [17] 0 0
United States of America
State/province [17] 0 0
South Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
South Dakota
Country [19] 0 0
United States of America
State/province [19] 0 0
Tennessee
Country [20] 0 0
United States of America
State/province [20] 0 0
Texas
Country [21] 0 0
United States of America
State/province [21] 0 0
Virginia
Country [22] 0 0
United States of America
State/province [22] 0 0
Washington
Country [23] 0 0
United States of America
State/province [23] 0 0
West Virginia
Country [24] 0 0
Brazil
State/province [24] 0 0
Paraná
Country [25] 0 0
Bulgaria
State/province [25] 0 0
Plovdiv
Country [26] 0 0
Bulgaria
State/province [26] 0 0
Sofia
Country [27] 0 0
Colombia
State/province [27] 0 0
Bogota
Country [28] 0 0
Czechia
State/province [28] 0 0
Bruntal
Country [29] 0 0
Czechia
State/province [29] 0 0
Hlucin
Country [30] 0 0
Czechia
State/province [30] 0 0
Ostrava
Country [31] 0 0
Czechia
State/province [31] 0 0
Pardubice
Country [32] 0 0
Czechia
State/province [32] 0 0
Praha 2
Country [33] 0 0
Czechia
State/province [33] 0 0
Uherske Hradiste
Country [34] 0 0
Estonia
State/province [34] 0 0
Tallinn
Country [35] 0 0
Georgia
State/province [35] 0 0
Ajaria
Country [36] 0 0
Georgia
State/province [36] 0 0
Kakheti
Country [37] 0 0
Georgia
State/province [37] 0 0
Tbilisi
Country [38] 0 0
Germany
State/province [38] 0 0
Berlin
Country [39] 0 0
Germany
State/province [39] 0 0
Hildesheim
Country [40] 0 0
Germany
State/province [40] 0 0
München
Country [41] 0 0
Germany
State/province [41] 0 0
Planegg
Country [42] 0 0
Germany
State/province [42] 0 0
Püttlingen
Country [43] 0 0
Germany
State/province [43] 0 0
Ratingen
Country [44] 0 0
Hungary
State/province [44] 0 0
Hajdú-bihar
Country [45] 0 0
Hungary
State/province [45] 0 0
Budapest
Country [46] 0 0
Hungary
State/province [46] 0 0
Veszprem
Country [47] 0 0
Japan
State/province [47] 0 0
Aichi
Country [48] 0 0
Japan
State/province [48] 0 0
Gunma
Country [49] 0 0
Japan
State/province [49] 0 0
Hokkaido
Country [50] 0 0
Japan
State/province [50] 0 0
Hyogo
Country [51] 0 0
Japan
State/province [51] 0 0
Nagasaki
Country [52] 0 0
Japan
State/province [52] 0 0
Saitama
Country [53] 0 0
Japan
State/province [53] 0 0
Fukuoka
Country [54] 0 0
Korea, Republic of
State/province [54] 0 0
Gwangju
Country [55] 0 0
Korea, Republic of
State/province [55] 0 0
Seoul
Country [56] 0 0
Lithuania
State/province [56] 0 0
Kaunas
Country [57] 0 0
Lithuania
State/province [57] 0 0
Klaipeda
Country [58] 0 0
Lithuania
State/province [58] 0 0
Vilnius
Country [59] 0 0
Mexico
State/province [59] 0 0
BAJA California
Country [60] 0 0
Mexico
State/province [60] 0 0
Ciudad de Mexico
Country [61] 0 0
New Zealand
State/province [61] 0 0
South Canterbury
Country [62] 0 0
New Zealand
State/province [62] 0 0
Hamilton
Country [63] 0 0
New Zealand
State/province [63] 0 0
Wellington
Country [64] 0 0
Peru
State/province [64] 0 0
Arequipa, Arequipa
Country [65] 0 0
Peru
State/province [65] 0 0
Arequipa
Country [66] 0 0
Peru
State/province [66] 0 0
Lima, Lima
Country [67] 0 0
Peru
State/province [67] 0 0
Lima
Country [68] 0 0
Poland
State/province [68] 0 0
Bialystok
Country [69] 0 0
Poland
State/province [69] 0 0
Elblag
Country [70] 0 0
Poland
State/province [70] 0 0
Gdynia
Country [71] 0 0
Poland
State/province [71] 0 0
Katowice
Country [72] 0 0
Poland
State/province [72] 0 0
Lublin
Country [73] 0 0
Poland
State/province [73] 0 0
Nadarzyn
Country [74] 0 0
Poland
State/province [74] 0 0
Poznan
Country [75] 0 0
Poland
State/province [75] 0 0
Torun
Country [76] 0 0
Poland
State/province [76] 0 0
Warszawa
Country [77] 0 0
Poland
State/province [77] 0 0
Wroclaw
Country [78] 0 0
Russian Federation
State/province [78] 0 0
Republic OF Karelia
Country [79] 0 0
Russian Federation
State/province [79] 0 0
Izhevsk
Country [80] 0 0
Russian Federation
State/province [80] 0 0
Kemerovo
Country [81] 0 0
Russian Federation
State/province [81] 0 0
Kursk
Country [82] 0 0
Russian Federation
State/province [82] 0 0
Moscow
Country [83] 0 0
Russian Federation
State/province [83] 0 0
Orenburg
Country [84] 0 0
Russian Federation
State/province [84] 0 0
Ryazan
Country [85] 0 0
Russian Federation
State/province [85] 0 0
Saint-Petersburg
Country [86] 0 0
Russian Federation
State/province [86] 0 0
Saratov
Country [87] 0 0
Russian Federation
State/province [87] 0 0
Vladimir
Country [88] 0 0
Russian Federation
State/province [88] 0 0
Yaroslavl
Country [89] 0 0
Serbia
State/province [89] 0 0
Belgrade
Country [90] 0 0
Serbia
State/province [90] 0 0
Niska Banja
Country [91] 0 0
Serbia
State/province [91] 0 0
Novi Sad
Country [92] 0 0
South Africa
State/province [92] 0 0
Gauteng
Country [93] 0 0
South Africa
State/province [93] 0 0
Kwa-zulu Natal
Country [94] 0 0
South Africa
State/province [94] 0 0
Western CAPE
Country [95] 0 0
Spain
State/province [95] 0 0
Madrid
Country [96] 0 0
Spain
State/province [96] 0 0
Vizcaya
Country [97] 0 0
Spain
State/province [97] 0 0
A Coruña
Country [98] 0 0
Spain
State/province [98] 0 0
Sevilla
Country [99] 0 0
Taiwan
State/province [99] 0 0
Taichung
Country [100] 0 0
Taiwan
State/province [100] 0 0
Taipei
Country [101] 0 0
Ukraine
State/province [101] 0 0
Kyiv
Country [102] 0 0
Ukraine
State/province [102] 0 0
Lviv
Country [103] 0 0
Ukraine
State/province [103] 0 0
M. Kharkiv
Country [104] 0 0
Ukraine
State/province [104] 0 0
M. Kyiv,
Country [105] 0 0
Ukraine
State/province [105] 0 0
Odesa
Country [106] 0 0
Ukraine
State/province [106] 0 0
Sumy
Country [107] 0 0
Ukraine
State/province [107] 0 0
Vinnytsia
Country [108] 0 0
Ukraine
State/province [108] 0 0
Zaporizhzhia
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Hampshire
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Merseyside
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Somerset
Country [112] 0 0
United Kingdom
State/province [112] 0 0
WEST Yorkshire

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

Ethics approval
Ethics application status

Summary
Brief summary
The study will assess the efficacy, safety, and immunogenicity of PF-06410293 and adalimumab
in combination with methotrexate in subjects with moderately to severly active rheumatoid
arthritis who have had an inadequate response to methotrexate.

In an additional optional portion of the study, during open label Treatment Period 3 (TP3), a
subset of subjects used a Prefilled Pen (PFP) to administer up to 3 injections of their study
treatment (PF-06410293) at home.
Trial website
https://clinicaltrials.gov/show/NCT02480153
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