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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/NCT02873936
Registration number
NCT02873936
Ethics application status
Date submitted
17/08/2016
Date registered
22/08/2016
Date last updated
13/05/2021
Titles & IDs
Public title
Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment
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Secondary ID [1]
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2016-000569-21
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Secondary ID [2]
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GS-US-417-0302
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Universal Trial Number (UTN)
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Trial acronym
FINCH 2
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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 - csDMARDs
Experimental: Filgotinib 200 mg - Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
Experimental: Filgotinib 100 mg - Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)
Placebo Comparator: Placebo - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily
Treatment: Drugs: csDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
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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]; subject'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 0-3 [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, 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)] = 3.2 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), Patient's Global Assessment of Disease Activity (visual analog scale: 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 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
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Assessment method [3]
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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 [3]
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Baseline; Week 12
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Secondary outcome [4]
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Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Week 24
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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), Patient's Global Assessment of Disease Activity (visual analog scale: 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 24
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Secondary outcome [5]
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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 [5]
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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 [5]
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Baseline; Week 12
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Secondary outcome [6]
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Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24
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Assessment method [6]
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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 [6]
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Weeks 4, 12, and 24
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Secondary outcome [7]
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Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24
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Assessment method [7]
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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 [7]
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Weeks 4, 12, and 24
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Secondary outcome [8]
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Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24
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Assessment method [8]
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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 [8]
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Weeks 4, and 24
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Secondary outcome [9]
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Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24
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Assessment method [9]
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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 [9]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [10]
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Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24
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Assessment method [10]
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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 [10]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [11]
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Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24
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Assessment method [11]
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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 [11]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [12]
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Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24
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Assessment method [12]
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PGA was assessed by the physician using a VAS on a scale of 0 (no disease activity) to 3 (maximum disease activity). A negative change from baseline indicates improvement.
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Timepoint [12]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [13]
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Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24
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Assessment method [13]
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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 [13]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [14]
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Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 24
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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 4, and 24
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Secondary outcome [15]
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Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24
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Assessment method [15]
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Timepoint [15]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [16]
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Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 4, 12, and 24
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Assessment method [16]
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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 [16]
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Weeks 4, 12, and 24
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Secondary outcome [17]
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Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 24
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Assessment method [17]
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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. A negative change from baseline indicates improvement.
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Timepoint [17]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [18]
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Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 4, and 24
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Assessment method [18]
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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 [18]
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Weeks 4, and 24
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Secondary outcome [19]
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Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12
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Assessment method [19]
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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 [19]
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Weeks 4, and 12
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Secondary outcome [20]
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American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24
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Assessment method [20]
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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.
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Timepoint [20]
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Weeks 4, 12, and 24
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Secondary outcome [21]
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Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24
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Assessment method [21]
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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.
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Timepoint [21]
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Weeks 4, 12, and 24
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Secondary outcome [22]
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Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24
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Assessment method [22]
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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.
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Timepoint [22]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [23]
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Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24
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Assessment method [23]
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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.
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Timepoint [23]
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Baseline; Weeks 4, 12, and 24
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Secondary outcome [24]
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SF-36 PCS Score at Weeks 4, 12, and 24
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Assessment method [24]
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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.
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Timepoint [24]
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Weeks 4, 12, and 24
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Secondary outcome [25]
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Change From Baseline in SF-36 PCS Score at Weeks 4, and 24
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Assessment method [25]
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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.
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Timepoint [25]
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Baseline; Weeks 4, and 24
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Secondary outcome [26]
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SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 24
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Assessment method [26]
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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.
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Timepoint [26]
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Weeks 4, 12, and 24
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Secondary outcome [27]
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Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 24
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Assessment method [27]
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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.
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Timepoint [27]
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0
Baseline; Weeks 4, 12, and 24
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Secondary outcome [28]
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FACIT-Fatigue Score at Weeks 4, 12, and 24
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Assessment method [28]
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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.
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Timepoint [28]
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Weeks 4, 12, and 24
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Secondary outcome [29]
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Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 24
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Assessment method [29]
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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).
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Timepoint [29]
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0
Baseline; Weeks 4, and 24
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Secondary outcome [30]
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Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24
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Assessment method [30]
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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.
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Timepoint [30]
0
0
Weeks 4, 12, and 24
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Secondary outcome [31]
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EQ-5D Current Health VAS at Weeks 4, 12, and 24
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Assessment method [31]
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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.
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Timepoint [31]
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0
Weeks 4, 12, and 24
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Secondary outcome [32]
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Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24
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Assessment method [32]
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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).
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Timepoint [32]
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0
Baseline; Weeks 4, 12, and 24
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Secondary outcome [33]
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Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
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Assessment method [33]
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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.
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Timepoint [33]
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0
Weeks 4, 12, and 24
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Secondary outcome [34]
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WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24
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Assessment method [34]
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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.
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Timepoint [34]
0
0
Weeks 4, 12, and 24
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Secondary outcome [35]
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WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24
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Assessment method [35]
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 [35]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [36]
0
0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24
Query!
Assessment method [36]
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 [36]
0
0
Weeks 4, 12, and 24
Query!
Secondary outcome [37]
0
0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24
Query!
Assessment method [37]
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 [37]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [38]
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 [38]
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 [38]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [39]
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 [39]
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 [39]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Secondary outcome [40]
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 [40]
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 [40]
0
0
Baseline; Weeks 4, 12, and 24
Query!
Eligibility
Key inclusion criteria
Key
- Have a diagnosis of RA (2010 American College of Rheumatology [ACR]/European League
Against Rheumatism [EULAR] criteria for RA), 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 screening and
Day 1
- Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
- Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for
the treatment of RA to which they have had an inadequate response or intolerance
Key
Query!
Minimum age
18
Years
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Query!
Maximum age
No limit
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Query!
Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Previous treatment with any janus kinase (JAK) inhibitor
NOTE: Other protocol Inclusion/ Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
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Query!
Query!
Query!
Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
Query!
Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
Query!
Actual
27/07/2016
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Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
26/06/2018
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Sample size
Target
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Accrual to date
Query!
Final
449
Query!
Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
0
0
- Victoria Park
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Recruitment postcode(s) [1]
0
0
- Victoria Park
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Recruitment outside Australia
Country [1]
0
0
United States of America
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State/province [1]
0
0
Alabama
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Country [2]
0
0
United States of America
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State/province [2]
0
0
Arizona
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Country [3]
0
0
United States of America
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State/province [3]
0
0
California
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Country [4]
0
0
United States of America
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State/province [4]
0
0
Florida
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Country [5]
0
0
United States of America
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State/province [5]
0
0
Georgia
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Country [6]
0
0
United States of America
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State/province [6]
0
0
Kansas
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Country [7]
0
0
United States of America
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State/province [7]
0
0
Kentucky
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Country [8]
0
0
United States of America
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State/province [8]
0
0
Maryland
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Country [9]
0
0
United States of America
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State/province [9]
0
0
Massachusetts
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Country [10]
0
0
United States of America
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State/province [10]
0
0
Michigan
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Country [11]
0
0
United States of America
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State/province [11]
0
0
Mississippi
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Country [12]
0
0
United States of America
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State/province [12]
0
0
Missouri
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Country [13]
0
0
United States of America
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State/province [13]
0
0
Nebraska
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Country [14]
0
0
United States of America
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State/province [14]
0
0
New Hampshire
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Country [15]
0
0
United States of America
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State/province [15]
0
0
New Jersey
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Country [16]
0
0
United States of America
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State/province [16]
0
0
New York
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Country [17]
0
0
United States of America
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State/province [17]
0
0
North Carolina
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Country [18]
0
0
United States of America
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State/province [18]
0
0
Ohio
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Country [19]
0
0
United States of America
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State/province [19]
0
0
Oklahoma
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Country [20]
0
0
United States of America
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State/province [20]
0
0
Pennsylvania
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Country [21]
0
0
United States of America
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State/province [21]
0
0
South Carolina
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Country [22]
0
0
United States of America
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State/province [22]
0
0
Tennessee
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Country [23]
0
0
United States of America
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State/province [23]
0
0
Texas
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Country [24]
0
0
Argentina
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State/province [24]
0
0
Buenos Aires
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Country [25]
0
0
Argentina
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State/province [25]
0
0
Caba
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Country [26]
0
0
Argentina
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State/province [26]
0
0
San Juan
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Country [27]
0
0
Belgium
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State/province [27]
0
0
Gent
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Country [28]
0
0
Belgium
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State/province [28]
0
0
Leuven
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Country [29]
0
0
Belgium
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State/province [29]
0
0
Merksem
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Country [30]
0
0
France
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State/province [30]
0
0
Montpellier
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Country [31]
0
0
Germany
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State/province [31]
0
0
Berlin
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Country [32]
0
0
Germany
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State/province [32]
0
0
Hamburg
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Country [33]
0
0
Germany
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State/province [33]
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0
Ratingen
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Country [34]
0
0
Hungary
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State/province [34]
0
0
Budapest
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Country [35]
0
0
Hungary
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State/province [35]
0
0
Gyula
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Country [36]
0
0
Hungary
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State/province [36]
0
0
Székesfehérvár
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Country [37]
0
0
Israel
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State/province [37]
0
0
Haifa
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Country [38]
0
0
Israel
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State/province [38]
0
0
Ramat Gan
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Country [39]
0
0
Japan
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State/province [39]
0
0
Hiroshima
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Country [40]
0
0
Japan
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State/province [40]
0
0
Izumo
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Country [41]
0
0
Japan
Query!
State/province [41]
0
0
Kato
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Country [42]
0
0
Japan
Query!
State/province [42]
0
0
Kawagoe
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Country [43]
0
0
Japan
Query!
State/province [43]
0
0
Kumamoto
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Country [44]
0
0
Japan
Query!
State/province [44]
0
0
Narashino
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Country [45]
0
0
Japan
Query!
State/province [45]
0
0
Okayama
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Country [46]
0
0
Japan
Query!
State/province [46]
0
0
Sagamihara
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Country [47]
0
0
Japan
Query!
State/province [47]
0
0
Sapporo
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Country [48]
0
0
Japan
Query!
State/province [48]
0
0
Shinjuku-Ku
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Country [49]
0
0
Japan
Query!
State/province [49]
0
0
Takaoka
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Country [50]
0
0
Japan
Query!
State/province [50]
0
0
Takasaki
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Country [51]
0
0
Japan
Query!
State/province [51]
0
0
Tokorozawa
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Country [52]
0
0
Japan
Query!
State/province [52]
0
0
Tokyo
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Country [53]
0
0
Japan
Query!
State/province [53]
0
0
Tomigusuku
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Country [54]
0
0
Korea, Republic of
Query!
State/province [54]
0
0
Seoul
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Country [55]
0
0
Mexico
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State/province [55]
0
0
Chihuahua
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Country [56]
0
0
Mexico
Query!
State/province [56]
0
0
Distrito Federal
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Country [57]
0
0
Mexico
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State/province [57]
0
0
Mérida
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Country [58]
0
0
Poland
Query!
State/province [58]
0
0
Bialystok
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Country [59]
0
0
Poland
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State/province [59]
0
0
Poznan
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Country [60]
0
0
Poland
Query!
State/province [60]
0
0
Warszawa
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Country [61]
0
0
Poland
Query!
State/province [61]
0
0
Wroclaw
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Country [62]
0
0
Spain
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State/province [62]
0
0
Madrid
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Country [63]
0
0
Spain
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State/province [63]
0
0
Málaga
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Country [64]
0
0
Spain
Query!
State/province [64]
0
0
Sabadell
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Country [65]
0
0
Spain
Query!
State/province [65]
0
0
Valencia
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Country [66]
0
0
Switzerland
Query!
State/province [66]
0
0
Sankt Gallen
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Country [67]
0
0
United Kingdom
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State/province [67]
0
0
Doncaster
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Country [68]
0
0
United Kingdom
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State/province [68]
0
0
Edinburgh
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Country [69]
0
0
United Kingdom
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State/province [69]
0
0
Goodmayes
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Country [70]
0
0
United Kingdom
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State/province [70]
0
0
Harlow
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Country [71]
0
0
United Kingdom
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State/province [71]
0
0
Newcastle upon Tyne
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
Gilead Sciences
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Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Commercial sector/Industry
Query!
Name [1]
0
0
Galapagos NV
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT02873936
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Gilead Study Director
Query!
Address
0
0
Gilead Sciences
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Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02873936
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