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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/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).
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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
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Secondary ID [1]
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B5381002, REFLECTIONS B538-02
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Secondary ID [2]
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B5381002
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis
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Condition category
Condition code
Musculoskeletal
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Osteoarthritis
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Inflammatory and Immune System
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Rheumatoid arthritis
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With an American College of Rheumatology 20% (ACR20) Response at Week 12: Period 1
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Assessment method [1]
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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).
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Number of Participants With an American College of Rheumatology 20% (ACR20) Response at Other Time Points Other Than Week 12: Period 1
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Assessment method [1]
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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).
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Timepoint [1]
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Weeks 2, 4, 6, 8, 18 and 26 (pre-dose)
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Secondary outcome [2]
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Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 2
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Assessment method [2]
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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).
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Timepoint [2]
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Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [3]
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Number of Participants With an American College of Rheumatology 20% (ACR20) Response: Period 3
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Assessment method [3]
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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).
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Timepoint [3]
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Weeks 52, 56, 66, 76 and 78
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Secondary outcome [4]
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Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 1
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Assessment method [4]
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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).
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Timepoint [4]
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Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [5]
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Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 2
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Assessment method [5]
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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).
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Timepoint [5]
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Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [6]
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Number of Participants With an American College of Rheumatology 50% (ACR50) Response: Period 3
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Assessment method [6]
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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).
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Timepoint [6]
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Weeks 52, 56, 66, 76 and 78
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Secondary outcome [7]
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Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 1
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Assessment method [7]
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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).
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Timepoint [7]
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Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [8]
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Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 2
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Assessment method [8]
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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).
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Timepoint [8]
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Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [9]
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Number of Participants With an American College of Rheumatology 70% (ACR70) Response: Period 3
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Assessment method [9]
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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).
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Timepoint [9]
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Weeks 52, 56, 66, 76 and 78
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Secondary outcome [10]
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Change From Baseline in Tender Joint Count: Period 1
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Assessment method [10]
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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).
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Timepoint [10]
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Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [11]
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Change From Baseline in Tender Joint Count: Period 2
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Assessment method [11]
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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).
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Timepoint [11]
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Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [12]
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Change From Baseline in Tender Joint Count: Period 3
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Assessment method [12]
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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).
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Timepoint [12]
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Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [13]
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Change From Baseline in Swollen Joint Count: Period 1
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Assessment method [13]
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Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
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Timepoint [13]
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Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [14]
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Change From Baseline in Swollen Joint Count: Period 2
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Assessment method [14]
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Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
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Timepoint [14]
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Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [15]
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Change From Baseline in Swollen Joint Count: Period 3
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Assessment method [15]
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Sixty-six (66) joints were assessed for swelling, the same as those listed for tender joint count, excluding the right and left hip joints.
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Timepoint [15]
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Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [16]
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Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 1
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Assessment method [16]
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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".
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Timepoint [16]
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Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [17]
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Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 2
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Assessment method [17]
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0
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".
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Timepoint [17]
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Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [18]
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Change From Baseline in Physician's Global Assessment of Arthritis (PGAA): Period 3
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Assessment method [18]
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0
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".
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Timepoint [18]
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Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [19]
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Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 1
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Assessment method [19]
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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.
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Timepoint [19]
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Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [20]
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Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 2
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Assessment method [20]
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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.
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Timepoint [20]
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Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [21]
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Change From Baseline in Patient's Assessment of Arthritis Pain (PAAP): Period 3
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Assessment method [21]
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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.
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Timepoint [21]
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Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [22]
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Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 1
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Assessment method [22]
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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".
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Timepoint [22]
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Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [23]
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Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 2
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Assessment method [23]
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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".
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Timepoint [23]
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0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [24]
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Change From Baseline in Patient's Global Assessment of Arthritis (PGA): Period 3
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Assessment method [24]
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0
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".
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Timepoint [24]
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0
Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [25]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 1
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Assessment method [25]
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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.
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Timepoint [25]
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0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [26]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 2
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Assessment method [26]
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0
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.
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Timepoint [26]
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0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [27]
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Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI): Period 3
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Assessment method [27]
0
0
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.
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Timepoint [27]
0
0
Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [28]
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Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 1
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Assessment method [28]
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0
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
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Timepoint [28]
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0
Baseline, Weeks1, 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [29]
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Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 2
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Assessment method [29]
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0
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
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Timepoint [29]
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0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [30]
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0
Change From Baseline in High-Sensitivity C-Reactive Protein (Hs-CRP): Period 3
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Assessment method [30]
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0
Serum samples were analyzed to determine the level of hs-CRP, which was an acute-phase reactant.
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Timepoint [30]
0
0
Baseline, Weeks 52, 56, 66, 76 and 78
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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
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Assessment method [31]
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0
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).
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Timepoint [31]
0
0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [32]
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0
Change From Baseline in Disease Activity Score-28 (4 Components Based on High-Sensitivity C-Reactive Protein) (DAS28-4 [CRP]): Period 2
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Assessment method [32]
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0
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).
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Timepoint [32]
0
0
Baseline, Weeks 26, 30, 36, 44 and 52 (pre-dose)
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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
Query!
Assessment method [33]
0
0
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).
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Timepoint [33]
0
0
Baseline, Weeks 52, 56, 66, 76 and 78
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Secondary outcome [34]
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Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 1
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Assessment method [34]
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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.
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Timepoint [34]
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0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
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Secondary outcome [35]
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0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 2
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Assessment method [35]
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0
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.
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Timepoint [35]
0
0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
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Secondary outcome [36]
0
0
Number of Participants Achieving European League Against Rheumatism (EULAR) Response: Period 3
Query!
Assessment method [36]
0
0
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.
Query!
Timepoint [36]
0
0
Weeks 52, 56, 66, 76 and 78
Query!
Secondary outcome [37]
0
0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 1
Query!
Assessment method [37]
0
0
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.
Query!
Timepoint [37]
0
0
Baseline, Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Query!
Secondary outcome [38]
0
0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 2
Query!
Assessment method [38]
0
0
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.
Query!
Timepoint [38]
0
0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Query!
Secondary outcome [39]
0
0
Number of Participants Achieving Disease Activity Score Remission (DAS <2.6): Period 3
Query!
Assessment method [39]
0
0
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.
Query!
Timepoint [39]
0
0
Weeks 52, 56, 66, 76 and 78
Query!
Secondary outcome [40]
0
0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response:Period 1
Query!
Assessment method [40]
0
0
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).
Query!
Timepoint [40]
0
0
Weeks 2, 4, 6, 8, 12, 18 and 26 (pre-dose)
Query!
Secondary outcome [41]
0
0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 2
Query!
Assessment method [41]
0
0
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).
Query!
Timepoint [41]
0
0
Weeks 26, 30, 36, 44 and 52 (pre-dose)
Query!
Secondary outcome [42]
0
0
Number of Participants Achieving American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Response: Period 3
Query!
Assessment method [42]
0
0
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).
Query!
Timepoint [42]
0
0
Weeks 52, 56, 66, 76 and 78
Query!
Secondary outcome [43]
0
0
Serum Concentration Versus Time Summary: Period 1
Query!
Assessment method [43]
0
0
Query!
Timepoint [43]
0
0
Pre-dose on Days 1, 15, 43, 85 and 183, and at any time during Day 8 visit
Query!
Secondary outcome [44]
0
0
Serum Concentration Versus Time Summary: Period 2
Query!
Assessment method [44]
0
0
Query!
Timepoint [44]
0
0
Pre-dose on Days 183, 211, 253 and 365
Query!
Secondary outcome [45]
0
0
Serum Concentration Versus Time Summary: Period 3
Query!
Assessment method [45]
0
0
Query!
Timepoint [45]
0
0
Pre-dose on Days 365, 393, 463, 547 and 575
Query!
Secondary outcome [46]
0
0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 1
Query!
Assessment method [46]
0
0
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.
Query!
Timepoint [46]
0
0
Baseline up to Week 26 (pre-dose)
Query!
Secondary outcome [47]
0
0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 2
Query!
Assessment method [47]
0
0
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.
Query!
Timepoint [47]
0
0
Week 26 dosing up to Week 52 (pre-dose)
Query!
Secondary outcome [48]
0
0
Number of Participants With Positive Anti-drug Antibodies (ADA) and Neutralizing Antibodies (NAb): Period 3
Query!
Assessment method [48]
0
0
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.
Query!
Timepoint [48]
0
0
Week 52 dosing up to follow-up visit (Week 92)
Query!
Secondary outcome [49]
0
0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 1
Query!
Assessment method [49]
0
0
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.
Query!
Timepoint [49]
0
0
Baseline (Day 1) up to Week 26 (pre-dose)
Query!
Secondary outcome [50]
0
0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 2
Query!
Assessment method [50]
0
0
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.
Query!
Timepoint [50]
0
0
Week 26 dosing up to Week 52 (pre-dose)
Query!
Secondary outcome [51]
0
0
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) and Treatment Related TEAEs: Period 3
Query!
Assessment method [51]
0
0
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.
Query!
Timepoint [51]
0
0
Week 52 dosing up to follow-up visit (Week 92)
Query!
Secondary outcome [52]
0
0
Number of Participants With Laboratory Abnormalities: Period 1
Query!
Assessment method [52]
0
0
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.
Query!
Timepoint [52]
0
0
Baseline (Day 1) up to Week 26 (pre-dose)
Query!
Secondary outcome [53]
0
0
Number of Participants With Laboratory Abnormalities: Period 2
Query!
Assessment method [53]
0
0
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.
Query!
Timepoint [53]
0
0
Week 26 dosing up to Week 52 (pre-dose)
Query!
Secondary outcome [54]
0
0
Number of Participants With Laboratory Abnormalities: Period 3
Query!
Assessment method [54]
0
0
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.
Query!
Timepoint [54]
0
0
Week 52 dosing up to follow-up visit (Week 92)
Query!
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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
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.
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
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
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
25/06/2015
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
6/12/2017
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
597
Query!
Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
Query!
Recruitment hospital [1]
0
0
Paradise Arthritis & Rheumatology Pty Ltd - Southport
Query!
Recruitment hospital [2]
0
0
The Queen Elizabeth Hospital - Woodville South
Query!
Recruitment hospital [3]
0
0
RK Will Pty Ltd - Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
4215 - Southport
Query!
Recruitment postcode(s) [2]
0
0
5011 - Woodville South
Query!
Recruitment postcode(s) [3]
0
0
6100 - Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Delaware
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Florida
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Idaho
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Iowa
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Kentucky
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Maryland
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Michigan
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Mississippi
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Nebraska
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
New Jersey
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
New York
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
North Carolina
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Ohio
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Pennsylvania
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
South Carolina
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
South Dakota
Query!
Country [19]
0
0
United States of America
Query!
State/province [19]
0
0
Tennessee
Query!
Country [20]
0
0
United States of America
Query!
State/province [20]
0
0
Texas
Query!
Country [21]
0
0
United States of America
Query!
State/province [21]
0
0
Virginia
Query!
Country [22]
0
0
United States of America
Query!
State/province [22]
0
0
Washington
Query!
Country [23]
0
0
United States of America
Query!
State/province [23]
0
0
West Virginia
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Paraná
Query!
Country [25]
0
0
Bulgaria
Query!
State/province [25]
0
0
Plovdiv
Query!
Country [26]
0
0
Bulgaria
Query!
State/province [26]
0
0
Sofia
Query!
Country [27]
0
0
Colombia
Query!
State/province [27]
0
0
Bogota
Query!
Country [28]
0
0
Czechia
Query!
State/province [28]
0
0
Bruntal
Query!
Country [29]
0
0
Czechia
Query!
State/province [29]
0
0
Hlucin
Query!
Country [30]
0
0
Czechia
Query!
State/province [30]
0
0
Ostrava
Query!
Country [31]
0
0
Czechia
Query!
State/province [31]
0
0
Pardubice
Query!
Country [32]
0
0
Czechia
Query!
State/province [32]
0
0
Praha 2
Query!
Country [33]
0
0
Czechia
Query!
State/province [33]
0
0
Uherske Hradiste
Query!
Country [34]
0
0
Estonia
Query!
State/province [34]
0
0
Tallinn
Query!
Country [35]
0
0
Georgia
Query!
State/province [35]
0
0
Ajaria
Query!
Country [36]
0
0
Georgia
Query!
State/province [36]
0
0
Kakheti
Query!
Country [37]
0
0
Georgia
Query!
State/province [37]
0
0
Tbilisi
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Berlin
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Hildesheim
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
München
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Planegg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Püttlingen
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Ratingen
Query!
Country [44]
0
0
Hungary
Query!
State/province [44]
0
0
Hajdú-bihar
Query!
Country [45]
0
0
Hungary
Query!
State/province [45]
0
0
Budapest
Query!
Country [46]
0
0
Hungary
Query!
State/province [46]
0
0
Veszprem
Query!
Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Aichi
Query!
Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Gunma
Query!
Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Hokkaido
Query!
Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Hyogo
Query!
Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Nagasaki
Query!
Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Saitama
Query!
Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Fukuoka
Query!
Country [54]
0
0
Korea, Republic of
Query!
State/province [54]
0
0
Gwangju
Query!
Country [55]
0
0
Korea, Republic of
Query!
State/province [55]
0
0
Seoul
Query!
Country [56]
0
0
Lithuania
Query!
State/province [56]
0
0
Kaunas
Query!
Country [57]
0
0
Lithuania
Query!
State/province [57]
0
0
Klaipeda
Query!
Country [58]
0
0
Lithuania
Query!
State/province [58]
0
0
Vilnius
Query!
Country [59]
0
0
Mexico
Query!
State/province [59]
0
0
BAJA California
Query!
Country [60]
0
0
Mexico
Query!
State/province [60]
0
0
Ciudad de Mexico
Query!
Country [61]
0
0
New Zealand
Query!
State/province [61]
0
0
South Canterbury
Query!
Country [62]
0
0
New Zealand
Query!
State/province [62]
0
0
Hamilton
Query!
Country [63]
0
0
New Zealand
Query!
State/province [63]
0
0
Wellington
Query!
Country [64]
0
0
Peru
Query!
State/province [64]
0
0
Arequipa, Arequipa
Query!
Country [65]
0
0
Peru
Query!
State/province [65]
0
0
Arequipa
Query!
Country [66]
0
0
Peru
Query!
State/province [66]
0
0
Lima, Lima
Query!
Country [67]
0
0
Peru
Query!
State/province [67]
0
0
Lima
Query!
Country [68]
0
0
Poland
Query!
State/province [68]
0
0
Bialystok
Query!
Country [69]
0
0
Poland
Query!
State/province [69]
0
0
Elblag
Query!
Country [70]
0
0
Poland
Query!
State/province [70]
0
0
Gdynia
Query!
Country [71]
0
0
Poland
Query!
State/province [71]
0
0
Katowice
Query!
Country [72]
0
0
Poland
Query!
State/province [72]
0
0
Lublin
Query!
Country [73]
0
0
Poland
Query!
State/province [73]
0
0
Nadarzyn
Query!
Country [74]
0
0
Poland
Query!
State/province [74]
0
0
Poznan
Query!
Country [75]
0
0
Poland
Query!
State/province [75]
0
0
Torun
Query!
Country [76]
0
0
Poland
Query!
State/province [76]
0
0
Warszawa
Query!
Country [77]
0
0
Poland
Query!
State/province [77]
0
0
Wroclaw
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Russian Federation
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Republic OF Karelia
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Russian Federation
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Izhevsk
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Russian Federation
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Kemerovo
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Russian Federation
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Kursk
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Country [82]
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Russian Federation
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Moscow
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Russian Federation
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Orenburg
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Russian Federation
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Ryazan
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Russian Federation
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Saint-Petersburg
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Russian Federation
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Saratov
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Russian Federation
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Vladimir
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Russian Federation
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Yaroslavl
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Serbia
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Belgrade
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Serbia
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Niska Banja
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Serbia
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Novi Sad
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South Africa
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Gauteng
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South Africa
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Kwa-zulu Natal
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South Africa
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Western CAPE
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Spain
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Madrid
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Spain
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Vizcaya
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Spain
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A Coruña
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Spain
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Sevilla
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Taichung
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Taiwan
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Taipei
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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M. Kharkiv
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Ukraine
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M. Kyiv,
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Ukraine
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Odesa
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Ukraine
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Sumy
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Ukraine
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Vinnytsia
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Ukraine
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Zaporizhzhia
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United Kingdom
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Hampshire
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United Kingdom
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Merseyside
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United Kingdom
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Somerset
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United Kingdom
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WEST Yorkshire
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Ethics approval
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02480153
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Contacts
Principal investigator
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Pfizer CT.gov Call Center
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02480153
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