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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02886728




Registration number
NCT02886728
Ethics application status
Date submitted
29/08/2016
Date registered
1/09/2016
Date last updated
1/06/2021

Titles & IDs
Public title
Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
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 Alone and in Combination With Methotrexate (MTX) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Are Naïve to MTX Therapy
Secondary ID [1] 0 0
2016-000570-37
Secondary ID [2] 0 0
GS-US-417-0303
Universal Trial Number (UTN)
Trial acronym
FINCH 3
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Filgotinib
Treatment: Drugs - Placebo to match filgotinib
Treatment: Drugs - MTX
Treatment: Drugs - Placebo to match MTX

Experimental: Filgotinib 200 mg + MTX - Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg

Experimental: Filgotinib 100 mg + MTX - Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg

Experimental: Filgotinib 200 mg Monotherapy - Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX

Active Comparator: MTX Monotherapy - Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg


Treatment: Drugs: Filgotinib
Tablet(s) administered orally once daily

Treatment: Drugs: Placebo to match filgotinib
Tablet(s) administered orally once daily

Treatment: Drugs: MTX
Capsule(s) administered orally once weekly

Treatment: Drugs: Placebo to match MTX
Capsule(s) administered orally once weekly

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

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 24 - 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.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24 - 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).
Timepoint [1] 0 0
Baseline; Week 24
Secondary outcome [2] 0 0
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 24 - 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 CRP 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.
Timepoint [2] 0 0
Week 24
Secondary outcome [3] 0 0
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24 - 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 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Timepoint [3] 0 0
Baseline; Week 24
Secondary outcome [4] 0 0
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24 - 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.
Timepoint [4] 0 0
Baseline; Week 24
Secondary outcome [5] 0 0
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24 - 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 52. Positive change in value indicates improvement (no or less severity of fatigue).
Timepoint [5] 0 0
Baseline; Week 24
Secondary outcome [6] 0 0
Change From Baseline in the mTSS at Week 52 - 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 [0 indicating no/normal JSN and 4 indicating complete loss of joint space]. The maximal TSS is 448. Positive change in value indicates progression of disease (more erosion of bone, less joint spaces).
Timepoint [6] 0 0
Baseline; Week 52
Secondary outcome [7] 0 0
Percentage of Participants Who Achieved ACR20 Response at Weeks 2, 4, 12, 36, and 52 - 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.
Timepoint [7] 0 0
Weeks 2, 4, 12, 36, and 52
Secondary outcome [8] 0 0
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [8] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [9] 0 0
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [9] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [10] 0 0
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 2, 4, 12, 36, and 52 - 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 (less disability).
Timepoint [10] 0 0
Baseline; Weeks 2, 4, 12, 36, and 52
Secondary outcome [11] 0 0
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [11] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [12] 0 0
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 2, 4, 12, 24, 36, and 52 - 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" 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.
Timepoint [12] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [13] 0 0
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [13] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [14] 0 0
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [14] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [15] 0 0
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [15] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [16] 0 0
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52
Timepoint [16] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [17] 0 0
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score = 0.22 at Weeks 2, 4, 12, 24, 36, and 52 - 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, 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.
Timepoint [17] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [18] 0 0
Change From Baseline in DAS28 (CRP) at Weeks 2, 4, 12, 24, 36, and 52 - The DAS28 score is a measure of the participant's disease activity calculated using the TJC (28 joints), SJC (28 joints), Patient's Global Assessment of Disease Activity (VAS: 0 = no disease activity to 100 = maximum disease activity), and CRP for a total possible score of 1 to 9.4. Higher values indicate higher disease activity. A negative change from baseline indicates improvement.
Timepoint [18] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [19] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) = 3.2 at Weeks 4, 12, 24, and 52 - 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 CRP 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.
Timepoint [19] 0 0
Weeks 4, 12, 24, and 52
Secondary outcome [20] 0 0
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 2, 4, 12, 36, and 52 - 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 CRP 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.
Timepoint [20] 0 0
Weeks 2, 4, 12, 36, and 52
Secondary outcome [21] 0 0
ACR N Percent Improvement (ACR-N) Response at Weeks 2, 4, 12, 24, 36, and 52 - 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 CRP). 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.
Timepoint [21] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [22] 0 0
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [22] 0 0
Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [23] 0 0
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 2, 4, 12, 24, 36, and 52 - 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.
Timepoint [23] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [24] 0 0
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 2, 4, 12, 24, 36, and 52 - 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 86. A negative change from baseline indicates improvement.
Timepoint [24] 0 0
Baseline; Weeks 2, 4, 12, 24, 36, and 52
Secondary outcome [25] 0 0
Percentage of Participants With no Radiographic Progression From Baseline at Weeks 24, and 52 - 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).
Timepoint [25] 0 0
Baseline; Weeks 24, and 52
Secondary outcome [26] 0 0
SF-36 PCS Score at Weeks 4, 12, 24, 36, and 52 - 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.
Timepoint [26] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [27] 0 0
Change From Baseline in SF-36 PCS Score at Weeks 4, 12, 36, and 52 - 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.
Timepoint [27] 0 0
Baseline; Weeks 4, 12, 36, and 52
Secondary outcome [28] 0 0
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, 24, 36, and 52 - 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.
Timepoint [28] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [29] 0 0
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, 24, 36, and 52 - 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.
Timepoint [29] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [30] 0 0
FACIT-Fatigue Score at Weeks 4, 12, 24, 36, and 52 - 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 scale for a total possible score of 52.
Timepoint [30] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [31] 0 0
Change From Baseline in FACIT-Fatigue Score at Weeks 4, 12, 36, and 52 - 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 52. Positive change in value indicates improvement (no or less severity of fatigue).
Timepoint [31] 0 0
Baseline; Weeks 4, 12, 36, and 52
Secondary outcome [32] 0 0
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, 24, 36, and 52 - 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.
Timepoint [32] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [33] 0 0
EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 - 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.
Timepoint [33] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [34] 0 0
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, 24, 36, and 52 - 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).
Timepoint [34] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [35] 0 0
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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. Higher numbers indicate greater impairment and less productivity.
Timepoint [35] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [36] 0 0
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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. Higher numbers indicate greater impairment and less productivity.
Timepoint [36] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [37] 0 0
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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. Higher numbers indicate greater impairment and less productivity.
Timepoint [37] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [38] 0 0
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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. Higher numbers indicate greater impairment and less productivity.
Timepoint [38] 0 0
Weeks 4, 12, 24, 36, and 52
Secondary outcome [39] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Timepoint [39] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [40] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Timepoint [40] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [41] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Timepoint [41] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52
Secondary outcome [42] 0 0
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, 24, 36, and 52 - The WPAI is a questionnaire that measures impairments in work activities in participants with RA which consists of 6 questions: currently employed; work time missed due to RA; work time missed due to other reasons; hours actually worked; degree RA affected productivity while working (0-10 VAS, with 0 indicating no effect and 10 indicating RA completely prevented the participant from working); 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, higher numbers indicate greater impairment and less productivity. A negative change from baseline indicates improvement.
Timepoint [42] 0 0
Baseline; Weeks 4, 12, 24, 36, and 52

Eligibility
Key inclusion criteria
Key

- Have a diagnosis of 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.

- Limited or no prior treatment with MTX

Key
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous treatment with any janus kinase (JAK) inhibitor

- Previous therapy for longer than 3 months with conventional synthetic disease
modifying antirheumatic drugs (csDMARDs) other than MTX or hydroxychloroquine

- Use of any licensed or investigational biologic disease-modifying antirheumatic drugs
(DMARDs)

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


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

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,TAS,WA
Recruitment hospital [1] 0 0
- Maroochydore
Recruitment hospital [2] 0 0
- Hobart
Recruitment hospital [3] 0 0
- Victoria Park
Recruitment postcode(s) [1] 0 0
- Maroochydore
Recruitment postcode(s) [2] 0 0
- Hobart
Recruitment postcode(s) [3] 0 0
- Victoria Park
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Maryland
Country [9] 0 0
United States of America
State/province [9] 0 0
Massachusetts
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Minnesota
Country [12] 0 0
United States of America
State/province [12] 0 0
Mississippi
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Nebraska
Country [15] 0 0
United States of America
State/province [15] 0 0
New Hampshire
Country [16] 0 0
United States of America
State/province [16] 0 0
New Jersey
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
North Carolina
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
Tennessee
Country [23] 0 0
United States of America
State/province [23] 0 0
Texas
Country [24] 0 0
Argentina
State/province [24] 0 0
Buenos Aires
Country [25] 0 0
Argentina
State/province [25] 0 0
Caba
Country [26] 0 0
Argentina
State/province [26] 0 0
Mendoza
Country [27] 0 0
Argentina
State/province [27] 0 0
Quilmes
Country [28] 0 0
Argentina
State/province [28] 0 0
San Fernando
Country [29] 0 0
Argentina
State/province [29] 0 0
San Juan
Country [30] 0 0
Argentina
State/province [30] 0 0
San Miguel de Tucumán
Country [31] 0 0
Belgium
State/province [31] 0 0
Flemish Brabant
Country [32] 0 0
Belgium
State/province [32] 0 0
Genk
Country [33] 0 0
Belgium
State/province [33] 0 0
Hasselt
Country [34] 0 0
Belgium
State/province [34] 0 0
Merksem
Country [35] 0 0
Bulgaria
State/province [35] 0 0
Dobrich
Country [36] 0 0
Bulgaria
State/province [36] 0 0
Haskovo
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Plovdiv
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Varna
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Vidin
Country [41] 0 0
Canada
State/province [41] 0 0
Ontario
Country [42] 0 0
Canada
State/province [42] 0 0
Quebec
Country [43] 0 0
Chile
State/province [43] 0 0
Santiago
Country [44] 0 0
Chile
State/province [44] 0 0
Temuco
Country [45] 0 0
Czechia
State/province [45] 0 0
Ostrava
Country [46] 0 0
Czechia
State/province [46] 0 0
Prague 2
Country [47] 0 0
Czechia
State/province [47] 0 0
Praha 4
Country [48] 0 0
Czechia
State/province [48] 0 0
Uherske Hradiste
Country [49] 0 0
Germany
State/province [49] 0 0
Aachen
Country [50] 0 0
Germany
State/province [50] 0 0
Hamburg
Country [51] 0 0
Germany
State/province [51] 0 0
Ratingen
Country [52] 0 0
Hong Kong
State/province [52] 0 0
Hong Kong
Country [53] 0 0
Hong Kong
State/province [53] 0 0
Tuen Mun
Country [54] 0 0
Hungary
State/province [54] 0 0
Bacs-Kiskun
Country [55] 0 0
Hungary
State/province [55] 0 0
Fejer
Country [56] 0 0
Hungary
State/province [56] 0 0
Budapest
Country [57] 0 0
Hungary
State/province [57] 0 0
Kistarcsa
Country [58] 0 0
India
State/province [58] 0 0
Ahmedabad
Country [59] 0 0
India
State/province [59] 0 0
Bangalore
Country [60] 0 0
India
State/province [60] 0 0
Delhi
Country [61] 0 0
India
State/province [61] 0 0
Jaipur
Country [62] 0 0
India
State/province [62] 0 0
Kolkata
Country [63] 0 0
India
State/province [63] 0 0
Lucknow
Country [64] 0 0
India
State/province [64] 0 0
Mangalore
Country [65] 0 0
India
State/province [65] 0 0
Mysuru
Country [66] 0 0
India
State/province [66] 0 0
Nagpur
Country [67] 0 0
India
State/province [67] 0 0
New Delhi
Country [68] 0 0
India
State/province [68] 0 0
Pune
Country [69] 0 0
India
State/province [69] 0 0
Secunderabad
Country [70] 0 0
India
State/province [70] 0 0
Srikakulam
Country [71] 0 0
India
State/province [71] 0 0
Surat
Country [72] 0 0
India
State/province [72] 0 0
Vadodara
Country [73] 0 0
India
State/province [73] 0 0
Visakhapatnam
Country [74] 0 0
Ireland
State/province [74] 0 0
Dublin 4
Country [75] 0 0
Israel
State/province [75] 0 0
Peta? Tiqwa
Country [76] 0 0
Italy
State/province [76] 0 0
Bologna
Country [77] 0 0
Italy
State/province [77] 0 0
Reggio Emilia
Country [78] 0 0
Japan
State/province [78] 0 0
Fukuoka
Country [79] 0 0
Japan
State/province [79] 0 0
Hamamatsu
Country [80] 0 0
Japan
State/province [80] 0 0
Hiroshima
Country [81] 0 0
Japan
State/province [81] 0 0
Kagoshima
Country [82] 0 0
Japan
State/province [82] 0 0
Kato
Country [83] 0 0
Japan
State/province [83] 0 0
Kawagoe
Country [84] 0 0
Japan
State/province [84] 0 0
Miyagi
Country [85] 0 0
Japan
State/province [85] 0 0
Nagaoka
Country [86] 0 0
Japan
State/province [86] 0 0
Nagasaki
Country [87] 0 0
Japan
State/province [87] 0 0
Okayama
Country [88] 0 0
Japan
State/province [88] 0 0
Sanuki
Country [89] 0 0
Japan
State/province [89] 0 0
Sapporo
Country [90] 0 0
Japan
State/province [90] 0 0
Sasebo
Country [91] 0 0
Japan
State/province [91] 0 0
Sayama
Country [92] 0 0
Japan
State/province [92] 0 0
Tokyo
Country [93] 0 0
Japan
State/province [93] 0 0
Ome
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Anyang-si
Country [95] 0 0
Korea, Republic of
State/province [95] 0 0
Daegu
Country [96] 0 0
Korea, Republic of
State/province [96] 0 0
Daejeon
Country [97] 0 0
Korea, Republic of
State/province [97] 0 0
Incheon
Country [98] 0 0
Korea, Republic of
State/province [98] 0 0
Seoul
Country [99] 0 0
Malaysia
State/province [99] 0 0
Batu Caves
Country [100] 0 0
Malaysia
State/province [100] 0 0
Kuala Lumpur
Country [101] 0 0
Mexico
State/province [101] 0 0
Yucatan
Country [102] 0 0
Mexico
State/province [102] 0 0
Chihuahua
Country [103] 0 0
Mexico
State/province [103] 0 0
Distrito Federal
Country [104] 0 0
Mexico
State/province [104] 0 0
Monterrey
Country [105] 0 0
Mexico
State/province [105] 0 0
Morelia
Country [106] 0 0
Mexico
State/province [106] 0 0
Mérida
Country [107] 0 0
New Zealand
State/province [107] 0 0
Canterbury
Country [108] 0 0
New Zealand
State/province [108] 0 0
Hamilton
Country [109] 0 0
New Zealand
State/province [109] 0 0
Newtown
Country [110] 0 0
New Zealand
State/province [110] 0 0
Papatoetoe
Country [111] 0 0
Poland
State/province [111] 0 0
Bialystok
Country [112] 0 0
Poland
State/province [112] 0 0
Bydgoszcz
Country [113] 0 0
Poland
State/province [113] 0 0
Bytom
Country [114] 0 0
Poland
State/province [114] 0 0
Dabrówka
Country [115] 0 0
Poland
State/province [115] 0 0
Elblag
Country [116] 0 0
Poland
State/province [116] 0 0
Gdynia
Country [117] 0 0
Poland
State/province [117] 0 0
Katowice
Country [118] 0 0
Poland
State/province [118] 0 0
Krakow
Country [119] 0 0
Poland
State/province [119] 0 0
Nowa Sól
Country [120] 0 0
Poland
State/province [120] 0 0
Poznan
Country [121] 0 0
Poland
State/province [121] 0 0
Torun
Country [122] 0 0
Poland
State/province [122] 0 0
Warszawa
Country [123] 0 0
Romania
State/province [123] 0 0
Mures
Country [124] 0 0
Romania
State/province [124] 0 0
Bucharest
Country [125] 0 0
Romania
State/province [125] 0 0
Oradea
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Barnaul
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Kemerovo
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Moscow
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Nizhniy Novgorod
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Saratov
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Yaroslavl
Country [132] 0 0
Serbia
State/province [132] 0 0
Belgrade
Country [133] 0 0
Slovakia
State/province [133] 0 0
Bratislava
Country [134] 0 0
Slovakia
State/province [134] 0 0
Prievidza
Country [135] 0 0
Slovakia
State/province [135] 0 0
Topol'cany
Country [136] 0 0
South Africa
State/province [136] 0 0
Cape Town
Country [137] 0 0
South Africa
State/province [137] 0 0
Durban
Country [138] 0 0
Spain
State/province [138] 0 0
Barcelona
Country [139] 0 0
Spain
State/province [139] 0 0
Barakaldo
Country [140] 0 0
Spain
State/province [140] 0 0
La Coruña
Country [141] 0 0
Spain
State/province [141] 0 0
Málaga
Country [142] 0 0
Spain
State/province [142] 0 0
Sabadell
Country [143] 0 0
Spain
State/province [143] 0 0
Santiago de Compostela
Country [144] 0 0
Spain
State/province [144] 0 0
Valencia
Country [145] 0 0
Taiwan
State/province [145] 0 0
Kaohsiung
Country [146] 0 0
Taiwan
State/province [146] 0 0
Taichung
Country [147] 0 0
Taiwan
State/province [147] 0 0
Tainan
Country [148] 0 0
Taiwan
State/province [148] 0 0
Taipei
Country [149] 0 0
Taiwan
State/province [149] 0 0
Taoyuan
Country [150] 0 0
Thailand
State/province [150] 0 0
Bangkok
Country [151] 0 0
Thailand
State/province [151] 0 0
Chiang Mai
Country [152] 0 0
Thailand
State/province [152] 0 0
Songkhla
Country [153] 0 0
Ukraine
State/province [153] 0 0
Dnipro
Country [154] 0 0
Ukraine
State/province [154] 0 0
Kharkiv
Country [155] 0 0
Ukraine
State/province [155] 0 0
Kherson
Country [156] 0 0
Ukraine
State/province [156] 0 0
Kyiv
Country [157] 0 0
Ukraine
State/province [157] 0 0
L'viv
Country [158] 0 0
Ukraine
State/province [158] 0 0
Vinnitsa
Country [159] 0 0
Ukraine
State/province [159] 0 0
Vinnytsya
Country [160] 0 0
Ukraine
State/province [160] 0 0
Zaporizhzhya
Country [161] 0 0
United Kingdom
State/province [161] 0 0
Edinburgh
Country [162] 0 0
United Kingdom
State/province [162] 0 0
Newcastle upon Tyne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Galapagos NV
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
The primary objective of this study is to evaluate the effects of filgotinib in combination
with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
Trial website
https://clinicaltrials.gov/show/NCT02886728
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications