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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/NCT02889796
Registration number
NCT02889796
Ethics application status
Date submitted
31/08/2016
Date registered
7/09/2016
Date last updated
9/06/2021
Titles & IDs
Public title
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
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Scientific title
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
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Secondary ID [1]
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2016-000568-41
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Secondary ID [2]
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GS-US-417-0301
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Universal Trial Number (UTN)
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Trial acronym
FINCH 1
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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
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - Adalimumab
Treatment: Drugs - Placebo to match adalimumab
Treatment: Drugs - MTX
Experimental: Filgotinib 200 mg - Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)
Experimental: Filgotinib 100 mg - Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX
Active Comparator: Adalimumab - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX
Experimental: Placebo to Filgotinib 200 mg - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.
Experimental: Placebo to Filgotinib 100 mg - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.
Placebo Comparator: Placebo Never Received Filgotinib - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.
Treatment: Drugs: Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: Adalimumab
40 mg administered via subcutaneous injection once every two weeks
Treatment: Drugs: Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
Treatment: Drugs: MTX
Commercially sourced tablet(s) administered orally
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Intervention code [1]
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Treatment: Drugs
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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 Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12
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Assessment method [1]
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ACR20 response is achieved when the participant has: =20% improvement (reduction) from baseline in tender joint count based on 68 joints (TJC68), swollen joint count based on 66 joints (SJC66) and in at least 3 of the following 5 items: physician's global assessment of disease activity (PGA) and subject's global assessment of disease activity (SGA) assessed using visual analog scale (VAS) on a scale of 0-100 (0 and 100 indicating no disease activity and maximum disease activity)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
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Timepoint [1]
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Week 12
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Secondary outcome [1]
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Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
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Assessment method [1]
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The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). When 6 or more categories are non-missing, total possible score is 3. If more than 2 categories are missing, the HAQ-DI score is set to missing. Negative change from baseline indicates improvement (less disability).
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Timepoint [1]
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Baseline; Week 12
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Secondary outcome [2]
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Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12
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Assessment method [2]
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The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP (CRP = hsCRP) for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
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Timepoint [2]
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Week 12
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Secondary outcome [3]
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Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
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Assessment method [3]
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Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces).
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Timepoint [3]
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Baseline; Week 24
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Secondary outcome [4]
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Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Week 12
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Assessment method [4]
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The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
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Assessment method [5]
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The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
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Timepoint [5]
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Baseline; Week 12
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Secondary outcome [6]
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Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12
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Assessment method [6]
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FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
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Timepoint [6]
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Baseline; Week 12
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Secondary outcome [7]
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Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, and 24
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Assessment method [7]
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ACR50 response is achieved when the participant has: =50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [7]
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Weeks 2, 4, 12, and 24
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Secondary outcome [8]
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Percentage of Participants Who Achieved ACR50 at Weeks 36, and 52
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Assessment method [8]
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ACR50 response is achieved when the participant has: =50% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [8]
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Weeks 36, and 52
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Secondary outcome [9]
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Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, and 24
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Assessment method [9]
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ACR70 response is achieved when the participant has: =70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [9]
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Weeks 2, 4, 12, and 24
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Secondary outcome [10]
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Percentage of Participants Who Achieved ACR70 at Weeks 36, and 52
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Assessment method [10]
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ACR70 response is achieved when the participant has: =70% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [10]
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Weeks 36, and 52
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Secondary outcome [11]
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Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, and 24
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Assessment method [11]
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ACR20 response is achieved when the participant has: =20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [11]
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Weeks 2, 4, and 24
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Secondary outcome [12]
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Percentage of Participants Who Achieved ACR20 Response at Weeks 36, and 52
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Assessment method [12]
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ACR20 response is achieved when the participant has: =20% improvement (reduction) from baseline in TJC68, SJC66 and in at least 3 of the following 5 items: PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions, 8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]; hsCRP. Participants with missing outcomes were set as non-responders.
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Timepoint [12]
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Weeks 36, and 52
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Secondary outcome [13]
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Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, and 24
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Assessment method [13]
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The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
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Timepoint [13]
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Baseline; Weeks 2, 4, and 24
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Secondary outcome [14]
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Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 36, and 52
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Assessment method [14]
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The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0 (no disability) to 3 (completely disabled). A negative change from baseline indicates improvement.
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Timepoint [14]
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Baseline; Weeks 36, and 52
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Secondary outcome [15]
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Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, and 24
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Assessment method [15]
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TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
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Timepoint [15]
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Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [16]
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Change From Baseline in Individual ACR Component: TJC68 at Weeks 36, and 52
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Assessment method [16]
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TJC was examined on 68 joints of the fingers, elbows, hips, knees, ankles, and toes distal for pain in response to pressure or passive motion at the study time points. Joint pain was scored as 0 = Absent; 1 = Present for each joint. The overall Tender Joint Count ranged from 0 to 68. A negative change from baseline indicates improvement.
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Timepoint [16]
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Baseline; Weeks 36, and 52
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Secondary outcome [17]
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Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, and 24
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Assessment method [17]
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The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
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Timepoint [17]
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Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [18]
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Change From Baseline in Individual ACR Component: SJC66 at Weeks 36, and 52
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Assessment method [18]
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The total SJC66 was based on 66 joints (same 68 joints counted in TJC68 minus hips). It was derived as the sum of all "1s" (presence of a joint swelling was scored as "1" and the absence of swelling was scored as "0," provided the joint was not replaced or could not be assessed due to other reasons) thus collected with no penalty considered for the joints not assessed or those which had been replaced. The range for SJC66 is 0 to 66. A negative change from baseline indicates improvement.
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Timepoint [18]
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Baseline; Weeks 36, and 52
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Secondary outcome [19]
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Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, and 24
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Assessment method [19]
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SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
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Timepoint [19]
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Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [20]
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Change From Baseline in Individual ACR Component: SGA at Weeks 36, and 52
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Assessment method [20]
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SGA was assessed by the participant using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
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Timepoint [20]
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Baseline; Weeks 36, and 52
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Secondary outcome [21]
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Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, and 24
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Assessment method [21]
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PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
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Timepoint [21]
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Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [22]
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Change From Baseline in Individual ACR Component: PGA at Weeks 36, and 52
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Assessment method [22]
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PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 100 (maximum disease activity). A negative change from baseline indicates improvement.
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Timepoint [22]
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Baseline; Weeks 36, and 52
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Secondary outcome [23]
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Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, and 24
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Assessment method [23]
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The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
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Timepoint [23]
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Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [24]
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Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 36, and 52
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Assessment method [24]
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The participant assessed their pain severity using a VAS on a scale of 0 (no pain) to 100 (severe pain). A negative change from baseline indicates improvement.
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Timepoint [24]
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Baseline; Weeks 36, and 52
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Secondary outcome [25]
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Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, and 24
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Assessment method [25]
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0
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Timepoint [25]
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Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [26]
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Change From Baseline in Individual ACR Component: hsCRP at Weeks 36, and 52
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Assessment method [26]
0
0
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Timepoint [26]
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Baseline; Weeks 36, and 52
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Secondary outcome [27]
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Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 2, 4, 12, and 24
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Assessment method [27]
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The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) = 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
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Timepoint [27]
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Weeks 2, 4, 12, and 24
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Secondary outcome [28]
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Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 36, and 52
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Assessment method [28]
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0
The HAQ-DI score is defined as the average of the scores of eight functional categories (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities), usually completed by the participant. Responses in each functional category are collected as 0 (without any difficulty) to 3 (unable to do a task in that area), with or without aids or devices. The eight category scores are averaged into an overall HAQ-DI score on a scale from 0-3 [0 (no disability) to 3 (completely disabled) when 6 or more categories are non-missing, so total possible score is 3. Improvement is defined as reduction in HAQ-DI, (baseline value - postbaseline value) = 0.22. If more than 2 categories are missing, the HAQ-DI score is set to missing. Participants with missing outcomes were set as non-responders.
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Timepoint [28]
0
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Weeks 36, and 52
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Secondary outcome [29]
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Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, and 24
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Assessment method [29]
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0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
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Timepoint [29]
0
0
Baseline; Weeks 2, 4, 12, and 24
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Secondary outcome [30]
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0
Change From Baseline in DAS28 (CRP) at Weeks 36, and 52
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Assessment method [30]
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0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
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Timepoint [30]
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0
Baseline; Weeks 36, and 52
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Secondary outcome [31]
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Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 2, 4, and 24
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Assessment method [31]
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0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
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Timepoint [31]
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Weeks 2, 4, and 24
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Secondary outcome [32]
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Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 36, and 52
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Assessment method [32]
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0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
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Timepoint [32]
0
0
Weeks 36, and 52
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Secondary outcome [33]
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0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, and 24
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Assessment method [33]
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0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
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Timepoint [33]
0
0
Weeks 2, 4, and 24
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Secondary outcome [34]
0
0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 36, and 52
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Assessment method [34]
0
0
The DAS28 score is a measure of the participant's disease activity calculated using the tender joint counts (28 joints), swollen joint counts (28 joints), SGA (VAS: 0 = no disease activity to 100 = maximum disease activity), and hsCRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. Participants with missing outcomes were set as non-responders.
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Timepoint [34]
0
0
Weeks 36, and 52
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Secondary outcome [35]
0
0
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 2, 4, 12, and 24
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Assessment method [35]
0
0
ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
Query!
Timepoint [35]
0
0
Weeks 2, 4, 12, and 24
Query!
Secondary outcome [36]
0
0
ACR N Percent Improvement (ACR-N) at Weeks 36, and 52
Query!
Assessment method [36]
0
0
ACR-N is defined as the smallest percentage improvement from baseline in swollen joints, tender joints and the median of the following 5 items (PGA, SGA, subject's pain assessment, HAQ-DI and hsCRP). It has a range between 0 and 100%. PGA and SGA assessed using VAS on a scale of 0-100 [0 and 100 indicating no disease activity and maximum disease activity]; subject's pain assessment using VAS on a scale of 0-100 [0 and 100 indicating no pain and unbearable pain]; HAQ-DI score contains 20 questions,8 components: dressing/grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 [0 and 3 indicating without difficulty and unable to do]. If this calculation results in a negative value, then the ACR-N is set to 0. The ACR-N value indicates an improvement of N%, with higher numbers indicating greater improvement.
Query!
Timepoint [36]
0
0
Weeks 36, and 52
Query!
Secondary outcome [37]
0
0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, and 24
Query!
Assessment method [37]
0
0
Good Response: DAS28(CRP) at visit =3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit =3.2 and improvement from baseline >0.6 and =1.2; DAS28(CRP) at visit >3.2 and =5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2.
No Response: DAS28(CRP) at visit =5.1 and improvement from baseline =0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline =1.2.
Query!
Timepoint [37]
0
0
Weeks 2, 4, 12, and 24
Query!
Secondary outcome [38]
0
0
Number of Participants With EULAR Response at Weeks 36, and 52
Query!
Assessment method [38]
0
0
Good Response: DAS28(CRP) at visit =3.2 and improvement from baseline >1.2. Moderate Response: DAS28(CRP) at visit =3.2 and improvement from baseline >0.6 and =1.2; DAS28(CRP) at visit >3.2 and =5.1 and improvement from baseline >0.6; DAS 28(CRP) at visit >5.1 and improvement from baseline >1.2.
No Response: DAS28(CRP) at visit =5.1 and improvement from baseline =0.6; DAS 28(CRP) >5.1 at visit and improvement from baseline =1.2.
Query!
Timepoint [38]
0
0
Weeks 36, and 52
Query!
Secondary outcome [39]
0
0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, and 24
Query!
Assessment method [39]
0
0
CDAI is calculated using formula: CDAI = TJC based on 28 joints (TJC28) + SJC based on 28 joints (SJC28) + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.
Query!
Timepoint [39]
0
0
Baseline; Weeks 2, 4, 12, and 24
Query!
Secondary outcome [40]
0
0
Change From Baseline in CDAI at Weeks 36, and 52
Query!
Assessment method [40]
0
0
CDAI is calculated using formula: CDAI = TJC28 + SJC28 + SGA + PGA. PGA and SGA are assessed using a VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. CDAI can range from 0 to 76, with higher score indicating more severe disease activity status. A negative change from baseline indicates improvement.
Query!
Timepoint [40]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [41]
0
0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, and 24
Query!
Assessment method [41]
0
0
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement.
Query!
Timepoint [41]
0
0
Baseline; Weeks 2, 4, 12, and 24
Query!
Secondary outcome [42]
0
0
Change From Baseline in SDAI at Weeks 36, and 52
Query!
Assessment method [42]
0
0
SDAI is a composite measure that sums the TJC28, SJC28, SGA, PGA, and the hsCRP (in mg/dL). PGA and SGA assessed using VAS on a scale of 0-10 [0 and 10 indicating no disease activity and maximum disease activity]. Higher score indicates more severe disease activity status and total possible score is 0 to 86. A negative change from baseline indicates improvement.
Query!
Timepoint [42]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [43]
0
0
Change From Baseline in mTSS at Week 52
Query!
Assessment method [43]
0
0
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. The mTSS (range [0-448]) is defined as the erosion score (range [0-280]) plus the joint space narrowing (JSN) score (range [0-168]). An erosion score of 0 to 5 is given to each joint in the hands and wrists, and a score of 0 to 10 is given to each joint in the feet where 0 indicates no erosion while 5 or 10 indicates extensive loss of bone (maximum erosion). JSN is scored from 0 to 4, with 0 indicating normal or no narrowing and 4 indicating complete loss of joint space. The maximal TSS is 448. Negative change in value indicates improvement (less erosion of bone, normal joint spaces).
Query!
Timepoint [43]
0
0
Baseline; Week 52
Query!
Secondary outcome [44]
0
0
Percentage of Participants With no Radiographic Progression From Baseline at Week 24
Query!
Assessment method [44]
0
0
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS = 0.5, Change in mTSS = 0 and Change in mTSS = smallest detectable change (SDC).
Query!
Timepoint [44]
0
0
Baseline; Weeks 24
Query!
Secondary outcome [45]
0
0
Percentage of Participants With no Radiographic Progression From Baseline at Week 52
Query!
Assessment method [45]
0
0
Participant's radiographs of bilateral hands, wrists and feet are taken and evaluated through central review using the mTSS method. No radiographic progression is defined by the change from baseline in mTSS and is reported for the following categories: Change in mTSS = 0.5, Change in mTSS = 0 and Change in mTSS = smallest detectable change (SDC).
Query!
Timepoint [45]
0
0
Baseline; Week 52
Query!
Secondary outcome [46]
0
0
36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Weeks 4, 12, and 24
Query!
Assessment method [46]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Query!
Timepoint [46]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [47]
0
0
SF-36 PCS Score at Weeks 36, and 52
Query!
Assessment method [47]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Query!
Timepoint [47]
0
0
Weeks 36, and 52
Query!
Secondary outcome [48]
0
0
Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
Query!
Assessment method [48]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [48]
0
0
Baseline; Weeks 4, and 24
Query!
Secondary outcome [49]
0
0
Change From Baseline in SF-36 PCS Score at Weeks 36, and 52
Query!
Assessment method [49]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [49]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [50]
0
0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
Query!
Assessment method [50]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Query!
Timepoint [50]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [51]
0
0
SF-36 MCS Score at Weeks 36, and 52
Query!
Assessment method [51]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning.
Query!
Timepoint [51]
0
0
Weeks 36, and 52
Query!
Secondary outcome [52]
0
0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
Query!
Assessment method [52]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [52]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [53]
0
0
Change From Baseline in SF-36 MCS Score at Weeks 36, and 52
Query!
Assessment method [53]
0
0
The SF-36 is a 36-item, self-reported, generic, comprehensive, and health-related quality of life questionnaire based on 8 health domains in 2 components: physical well-being (physical functioning, role-physical, bodily pain, general health perceptions), mental well-being (vitality, social functioning, role-emotional, and mental health). Each domain is scored by summing the individual items and transforming the scores into a 0 to 100 scale with highest possible score of 100. Higher scores indicate better health status or functioning. Positive change in value indicates improvement and better quality of life.
Query!
Timepoint [53]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [54]
0
0
Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Weeks 4, 12, and 24
Query!
Assessment method [54]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52.
Query!
Timepoint [54]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [55]
0
0
FACIT-Fatigue Score at Weeks 36, and 52
Query!
Assessment method [55]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52.
Query!
Timepoint [55]
0
0
Weeks 36, and 52
Query!
Secondary outcome [56]
0
0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
Query!
Assessment method [56]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Query!
Timepoint [56]
0
0
Baseline; Weeks 4, and 24
Query!
Secondary outcome [57]
0
0
Change From Baseline in FACIT-Fatigue Score at Weeks 36, and 52
Query!
Assessment method [57]
0
0
FACIT-Fatigue scale is a brief, 13-item, symptom-specific questionnaire that specifically assesses the self-reported severity of fatigue and its impact upon daily activities and functioning in the past 7 days. The FACIT-Fatigue uses 0 (not at all) to 4 (very much) numeric rating scales for a total possible score of 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).
Query!
Timepoint [57]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [58]
0
0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
Query!
Assessment method [58]
0
0
The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Query!
Timepoint [58]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [59]
0
0
Number of Participants by EQ-5D Health Profile Categories at Weeks 36, and 52
Query!
Assessment method [59]
0
0
The EQ-5D-5 levels (EQ-5D-5L) is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. EQ-5D-5L consists of 2 components: a descriptive system of the participant's health and a rating of his or her current health state on a 0-100 VAS. The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. Rating gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Query!
Timepoint [59]
0
0
Weeks 36, and 52
Query!
Secondary outcome [60]
0
0
EQ-5D Current Health VAS at Weeks 4, 12, and 24
Query!
Assessment method [60]
0
0
EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Query!
Timepoint [60]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [61]
0
0
EQ-5D Current Health VAS at Weeks 36, and 52
Query!
Assessment method [61]
0
0
EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health.
Query!
Timepoint [61]
0
0
Weeks 36, and 52
Query!
Secondary outcome [62]
0
0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
Query!
Assessment method [62]
0
0
The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Query!
Timepoint [62]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [63]
0
0
Change From Baseline in EQ-5D Current Health VAS at Weeks 36, and 52
Query!
Assessment method [63]
0
0
The EQ-5D-5L is a standardized measure of health status of the participant at the visit (same day) that provides a simple, generic measure of health for clinical and economic appraisal. Participant rates their current health state on a 0-100 VAS. It gets recorded on a vertical VAS in which the endpoints are labeled best imaginable health state is 100 (on the top) and worst imaginable health state is 0 (on the bottom). Higher scores of EQ VAS indicate better health. Positive change indicates improvement (better health).
Query!
Timepoint [63]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [64]
0
0
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Query!
Assessment method [64]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [64]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [65]
0
0
WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Query!
Assessment method [65]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [65]
0
0
Weeks 36, and 52
Query!
Secondary outcome [66]
0
0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Query!
Assessment method [66]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [66]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [67]
0
0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Query!
Assessment method [67]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [67]
0
0
Weeks 36, and 52
Query!
Secondary outcome [68]
0
0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Query!
Assessment method [68]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [68]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [69]
0
0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Query!
Assessment method [69]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [69]
0
0
Weeks 36, and 52
Query!
Secondary outcome [70]
0
0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Query!
Assessment method [70]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [70]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [71]
0
0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Query!
Assessment method [71]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity.
Query!
Timepoint [71]
0
0
Weeks 36, and 52
Query!
Secondary outcome [72]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Query!
Assessment method [72]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [72]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [73]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 36, and 52
Query!
Assessment method [73]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Absenteeism (work time missed) due to RA: 100×{Q2/(Q2+Q4)}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [73]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [74]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
Query!
Assessment method [74]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [74]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [75]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 36, and 52
Query!
Assessment method [75]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Presenteeism (impairment while working) due to RA: 100×{Q5/10}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [75]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [76]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
Query!
Assessment method [76]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [76]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [77]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 36, and 52
Query!
Assessment method [77]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Work productivity loss (overall work impairment) due to RA: 100×{Q2/(Q2+Q4) + [(1-Q2/(Q2+Q4) × (Q5/10)]}. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [77]
0
0
Baseline; Weeks 36, and 52
Query!
Secondary outcome [78]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Query!
Assessment method [78]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [78]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [79]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 36, and 52
Query!
Assessment method [79]
0
0
The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: Q1-currently employed; Q2-work time missed due to RA; Q3-work time missed due to other reasons; Q4-hours actually worked; Q5-degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); Q6-degree RA affected productivity in regular unpaid activities (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant's daily activities). Outcomes are expressed as impairment percentages: Activity impairment due to RA: 100×{Q6/10}. If Question 1 (Are you currently employed?) is 'NO', then only the activity impairment score can be determined. Higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Query!
Timepoint [79]
0
0
Baseline; Weeks 36, and 52
Query!
Eligibility
Key inclusion criteria
Key
- Have a diagnosis of rheumatoid arthritis (RA) [2010 American College of Rheumatology
(ACR)/European League Against Rheumatism (EULAR) criteria] , and are ACR functional
class I-III.
- Have = 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and =
6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both
screening and Day 1.
- Ongoing treatment with a stable dose of MTX
Key
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
- Previous treatment with any janus kinase (JAK) inhibitor
NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
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 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
30/08/2016
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
20/06/2019
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1759
Query!
Recruitment in Australia
Recruitment state(s)
WA
Query!
Recruitment hospital [1]
0
0
- Victoria Park
Query!
Recruitment postcode(s) [1]
0
0
- Victoria Park
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
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
Kansas
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Kentucky
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Maryland
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
Michigan
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Minnesota
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
Missouri
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 Mexico
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
Pennsylvania
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
South Carolina
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Tennessee
Query!
Country [18]
0
0
United States of America
Query!
State/province [18]
0
0
Texas
Query!
Country [19]
0
0
Argentina
Query!
State/province [19]
0
0
Buenos Aires
Query!
Country [20]
0
0
Argentina
Query!
State/province [20]
0
0
Caba
Query!
Country [21]
0
0
Argentina
Query!
State/province [21]
0
0
Mendoza
Query!
Country [22]
0
0
Argentina
Query!
State/province [22]
0
0
Quilmes
Query!
Country [23]
0
0
Argentina
Query!
State/province [23]
0
0
San Fernando
Query!
Country [24]
0
0
Argentina
Query!
State/province [24]
0
0
San Juan
Query!
Country [25]
0
0
Argentina
Query!
State/province [25]
0
0
San Miguel De Tucumán
Query!
Country [26]
0
0
Belgium
Query!
State/province [26]
0
0
Brussels
Query!
Country [27]
0
0
Belgium
Query!
State/province [27]
0
0
Genk
Query!
Country [28]
0
0
Belgium
Query!
State/province [28]
0
0
Merksem
Query!
Country [29]
0
0
Bulgaria
Query!
State/province [29]
0
0
Dobrich
Query!
Country [30]
0
0
Bulgaria
Query!
State/province [30]
0
0
Haskovo
Query!
Country [31]
0
0
Bulgaria
Query!
State/province [31]
0
0
Plovdiv
Query!
Country [32]
0
0
Bulgaria
Query!
State/province [32]
0
0
Sofia
Query!
Country [33]
0
0
Bulgaria
Query!
State/province [33]
0
0
Varna
Query!
Country [34]
0
0
Bulgaria
Query!
State/province [34]
0
0
Vidin
Query!
Country [35]
0
0
Canada
Query!
State/province [35]
0
0
Quebec
Query!
Country [36]
0
0
Czechia
Query!
State/province [36]
0
0
Praha
Query!
Country [37]
0
0
Czechia
Query!
State/province [37]
0
0
Brno
Query!
Country [38]
0
0
Czechia
Query!
State/province [38]
0
0
Ostrava-Poruba
Query!
Country [39]
0
0
Czechia
Query!
State/province [39]
0
0
Ostrava
Query!
Country [40]
0
0
Czechia
Query!
State/province [40]
0
0
Prague 10
Query!
Country [41]
0
0
Czechia
Query!
State/province [41]
0
0
Praha 4
Query!
Country [42]
0
0
Czechia
Query!
State/province [42]
0
0
Uherske Hradiste
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Frankfurt a Main
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Hamburg
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Ratingen
Query!
Country [46]
0
0
Hong Kong
Query!
State/province [46]
0
0
Hong Kong
Query!
Country [47]
0
0
Hungary
Query!
State/province [47]
0
0
Bacs-kiskun
Query!
Country [48]
0
0
Hungary
Query!
State/province [48]
0
0
Csongrad
Query!
Country [49]
0
0
Hungary
Query!
State/province [49]
0
0
Fejer
Query!
Country [50]
0
0
Hungary
Query!
State/province [50]
0
0
Budapest
Query!
Country [51]
0
0
Hungary
Query!
State/province [51]
0
0
Eger
Query!
Country [52]
0
0
India
Query!
State/province [52]
0
0
Ahmedabad
Query!
Country [53]
0
0
India
Query!
State/province [53]
0
0
Bangalore
Query!
Country [54]
0
0
India
Query!
State/province [54]
0
0
Chennai
Query!
Country [55]
0
0
India
Query!
State/province [55]
0
0
Delhi
Query!
Country [56]
0
0
India
Query!
State/province [56]
0
0
Gurgaon
Query!
Country [57]
0
0
India
Query!
State/province [57]
0
0
Hyderabad
Query!
Country [58]
0
0
India
Query!
State/province [58]
0
0
Jaipur
Query!
Country [59]
0
0
India
Query!
State/province [59]
0
0
Kolkata
Query!
Country [60]
0
0
India
Query!
State/province [60]
0
0
Lucknow
Query!
Country [61]
0
0
India
Query!
State/province [61]
0
0
Mangalore
Query!
Country [62]
0
0
India
Query!
State/province [62]
0
0
Nagpur
Query!
Country [63]
0
0
India
Query!
State/province [63]
0
0
New Delhi
Query!
Country [64]
0
0
India
Query!
State/province [64]
0
0
Pune
Query!
Country [65]
0
0
India
Query!
State/province [65]
0
0
Secunderabad
Query!
Country [66]
0
0
India
Query!
State/province [66]
0
0
Srikakulam
Query!
Country [67]
0
0
India
Query!
State/province [67]
0
0
Surat
Query!
Country [68]
0
0
India
Query!
State/province [68]
0
0
Vadodara
Query!
Country [69]
0
0
India
Query!
State/province [69]
0
0
Visakhapatnam
Query!
Country [70]
0
0
Ireland
Query!
State/province [70]
0
0
Dublin 4
Query!
Country [71]
0
0
Israel
Query!
State/province [71]
0
0
Haifa
Query!
Country [72]
0
0
Israel
Query!
State/province [72]
0
0
Tel Aviv
Query!
Country [73]
0
0
Israel
Query!
State/province [73]
0
0
Tel-Hashomer
Query!
Country [74]
0
0
Italy
Query!
State/province [74]
0
0
Bologna
Query!
Country [75]
0
0
Italy
Query!
State/province [75]
0
0
Catania
Query!
Country [76]
0
0
Italy
Query!
State/province [76]
0
0
Milano
Query!
Country [77]
0
0
Japan
Query!
State/province [77]
0
0
Chiba-shi
Query!
Country [78]
0
0
Japan
Query!
State/province [78]
0
0
Fukuoka
Query!
Country [79]
0
0
Japan
Query!
State/province [79]
0
0
Hiroshima
Query!
Country [80]
0
0
Japan
Query!
State/province [80]
0
0
Iizuka-shi
Query!
Country [81]
0
0
Japan
Query!
State/province [81]
0
0
Iruma-gun
Query!
Country [82]
0
0
Japan
Query!
State/province [82]
0
0
Izumo
Query!
Country [83]
0
0
Japan
Query!
State/province [83]
0
0
Kagoshima-shi
Query!
Country [84]
0
0
Japan
Query!
State/province [84]
0
0
Kato
Query!
Country [85]
0
0
Japan
Query!
State/province [85]
0
0
Kitakyushu-shi
Query!
Country [86]
0
0
Japan
Query!
State/province [86]
0
0
Kobe
Query!
Country [87]
0
0
Japan
Query!
State/province [87]
0
0
Kumamoto
Query!
Country [88]
0
0
Japan
Query!
State/province [88]
0
0
Kurume-shi
Query!
Country [89]
0
0
Japan
Query!
State/province [89]
0
0
Kyoto-shi
Query!
Country [90]
0
0
Japan
Query!
State/province [90]
0
0
Kyoto
Query!
Country [91]
0
0
Japan
Query!
State/province [91]
0
0
Miyazaki
Query!
Country [92]
0
0
Japan
Query!
State/province [92]
0
0
Morioka
Query!
Country [93]
0
0
Japan
Query!
State/province [93]
0
0
Nagaoka
Query!
Country [94]
0
0
Japan
Query!
State/province [94]
0
0
Nagasaki-shi
Query!
Country [95]
0
0
Japan
Query!
State/province [95]
0
0
Nagasaki
Query!
Country [96]
0
0
Japan
Query!
State/province [96]
0
0
Nagoya
Query!
Country [97]
0
0
Japan
Query!
State/province [97]
0
0
Narashino
Query!
Country [98]
0
0
Japan
Query!
State/province [98]
0
0
Nishinomiya
Query!
Country [99]
0
0
Japan
Query!
State/province [99]
0
0
Sanuki-shi
Query!
Country [100]
0
0
Japan
Query!
State/province [100]
0
0
Sapporo
Query!
Country [101]
0
0
Japan
Query!
State/province [101]
0
0
Sasebo-shi
Query!
Country [102]
0
0
Japan
Query!
State/province [102]
0
0
Sayama-shi
Query!
Country [103]
0
0
Japan
Query!
State/province [103]
0
0
Shibata-City
Query!
Country [104]
0
0
Japan
Query!
State/province [104]
0
0
Shinjuku-Ku
Query!
Country [105]
0
0
Japan
Query!
State/province [105]
0
0
Shizuoka
Query!
Country [106]
0
0
Japan
Query!
State/province [106]
0
0
Suita-shi
Query!
Country [107]
0
0
Japan
Query!
State/province [107]
0
0
Takaoka
Query!
Country [108]
0
0
Japan
Query!
State/province [108]
0
0
Takasaki-shi
Query!
Country [109]
0
0
Japan
Query!
State/province [109]
0
0
Tokorozawa
Query!
Country [110]
0
0
Japan
Query!
State/province [110]
0
0
Tokyo
Query!
Country [111]
0
0
Japan
Query!
State/province [111]
0
0
Tsukuba-shi
Query!
Country [112]
0
0
Japan
Query!
State/province [112]
0
0
Wakayama
Query!
Country [113]
0
0
Japan
Query!
State/province [113]
0
0
Yokohama-shi
Query!
Country [114]
0
0
Japan
Query!
State/province [114]
0
0
Oita
Query!
Country [115]
0
0
Korea, Republic of
Query!
State/province [115]
0
0
Anyang-si
Query!
Country [116]
0
0
Korea, Republic of
Query!
State/province [116]
0
0
Busan
Query!
Country [117]
0
0
Korea, Republic of
Query!
State/province [117]
0
0
Daegu
Query!
Country [118]
0
0
Korea, Republic of
Query!
State/province [118]
0
0
Daejeon
Query!
Country [119]
0
0
Korea, Republic of
Query!
State/province [119]
0
0
Gwangju
Query!
Country [120]
0
0
Korea, Republic of
Query!
State/province [120]
0
0
Incheon
Query!
Country [121]
0
0
Korea, Republic of
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State/province [121]
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Jeonju
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Korea, Republic of
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Seoul
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Mexico
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Yucatan
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Mexico
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Chihuahua
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Mexico
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Ciudad de Mexico
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Mexico
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Distrito Federal
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Mexico
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Monterrey
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Mexico
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Morelia
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Mexico
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Mérida
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Netherlands
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Leiden
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New Zealand
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Auckland
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New Zealand
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Hamilton
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New Zealand
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Newtown
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New Zealand
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Timaru
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Poland
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Dolnoslaskie
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Bytom
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Poland
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Elblag
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Poland
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Gdynia
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Country [141]
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Poland
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Kartuzy
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Nowa Sól
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Poland
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Poznan
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Poland
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Tomaszów Lubelski
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Poland
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Torun
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Poland
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Warsaw
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Poland
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Warszawa
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Romania
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Bihor
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Romania
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Bucuresti
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Romania
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Bacau
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Romania
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Târgu-Mures
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Russian Federation
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Barnaul
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Russian Federation
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Chelyabinsk
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Russian Federation
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Kazan
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Russian Federation
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Kemerovo
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Russian Federation
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Moscow
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Russian Federation
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Nizhniy Novgorod
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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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Country [163]
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Russian Federation
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Yaroslavl
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Country [164]
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Serbia
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State/province [164]
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Belgrade
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Serbia
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State/province [165]
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Niška Banja
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Country [166]
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Slovakia
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State/province [166]
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Bratislava
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Slovakia
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Prievidza
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Slovakia
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State/province [168]
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Rimavska Sobota
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Slovakia
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Topol'cany
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South Africa
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Cape Town
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South Africa
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Durban
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South Africa
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Johannesburg
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Spain
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La Coruna
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Spain
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Málaga
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Spain
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Sabadell
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Spain
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Santiago de Compostela
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Spain
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Valencia
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Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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Keelung
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Taiwan
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Taichung
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Country [182]
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Thailand
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Bangkok
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Thailand
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Chiangmai
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Thailand
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Songkla
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Country [188]
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Ukraine
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State/province [188]
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Dnipro
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Country [189]
0
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Ukraine
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State/province [189]
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Kharkiv
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Country [190]
0
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Ukraine
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Kherson
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Country [191]
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Country [193]
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Ukraine
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L'viv
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Ukraine
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Luts'k
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Ukraine
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Lviv
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Ukraine
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Odessa
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Country [197]
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Ukraine
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Vinnytsia
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Ukraine
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Vinnytsya
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Ukraine
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Zaporizhzhya
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United Kingdom
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England
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Country [201]
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United Kingdom
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Doncaster
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United Kingdom
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Edinburgh
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Warrington
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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Galapagos NV
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Address [1]
0
0
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0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of this study is to evaluate the effects of filgotinib versus placebo
for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the
percentage of participants achieving an American College of Rheumatology 20% improvement
response (ACR20) at Week 12.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02889796
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Public notes
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Contacts
Principal investigator
Name
0
0
Gilead Study Director
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Address
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Gilead Sciences
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02889796
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