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 (FINCH 2)

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Filgotinib; Drug: Placebo to match filgotinib; Drug: csDMARDs

• Study Type: Interventional
• Enrollment (Actual): 449
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Caba, Argentina
  • San Juan, Argentina
• Australia
  • Western Australia
    • Victoria Park, Western Australia, Australia
• Belgium
  • Gent, Belgium
  • Leuven, Belgium
  • Merksem, Belgium
• France
  • Montpellier, France
• Germany
  • Berlin, Germany
  • Hamburg, Germany
  • Ratingen, Germany
• Hungary
  • Budapest, Hungary
  • Gyula, Hungary
  • Székesfehérvár, Hungary
• Israel
  • Haifa, Israel
  • Ramat Gan, Israel
• Japan
  • Hiroshima, Japan
  • Izumo, Japan
  • Katō, Japan
  • Kawagoe, Japan
  • Kumamoto, Japan
  • Narashino, Japan
  • Okayama, Japan
  • Sagamihara, Japan
  • Sapporo, Japan
  • Shinjuku-Ku, Japan
  • Takaoka, Japan
  • Takasaki, Japan
  • Tokorozawa, Japan
  • Tokyo, Japan
  • Tomigusuku, Japan
• Korea, Republic of
  • Seoul, Korea, Republic of
• Mexico
  • Chihuahua, Mexico
  • Distrito Federal, Mexico
  • Mérida, Mexico
• Poland
  • Białystok, Poland
  • Poznań, Poland
  • Warszawa, Poland
  • Wroclaw, Poland
• Spain
  • Madrid, Spain
  • Málaga, Spain
  • Sabadell, Spain
  • Valencia, Spain
• Switzerland
  • Sankt Gallen, Switzerland
• United Kingdom
  • Doncaster, United Kingdom
  • Edinburgh, United Kingdom
  • Goodmayes, United Kingdom
  • Harlow, United Kingdom
  • Newcastle upon Tyne, United Kingdom
• United States
  • Alabama
    • Huntsville, Alabama, United States
  • Arizona
    • Gilbert, Arizona, United States
  • California
    • Covina, California, United States
    • Hemet, California, United States
    • La Jolla, California, United States
    • Palm Desert, California, United States
    • Palo Alto, California, United States
    • Riverside, California, United States
    • Upland, California, United States
    • Victorville, California, United States
    • Whittier, California, United States
  • Florida
    • Aventura, Florida, United States
    • DeBary, Florida, United States
    • Jacksonville, Florida, United States
    • Miami, Florida, United States
    • Orlando, Florida, United States
    • Plantation, Florida, United States
    • Port Richey, Florida, United States
  • Georgia
    • Decatur, Georgia, United States
  • Kansas
    • Kansas City, Kansas, United States
    • Wichita, Kansas, United States
  • Kentucky
    • Elizabethtown, Kentucky, United States
    • Lexington, Kentucky, United States
  • Maryland
    • Cumberland, Maryland, United States
    • Frederick, Maryland, United States
  • Massachusetts
    • Worcester, Massachusetts, United States
  • Michigan
    • Detroit, Michigan, United States
    • Saint Clair Shores, Michigan, United States
  • Mississippi
    • Hattiesburg, Mississippi, United States
    • Tupelo, Mississippi, United States
  • Missouri
    • Saint Louis, Missouri, United States
  • Nebraska
    • Lincoln, Nebraska, United States
  • New Hampshire
    • Lebanon, New Hampshire, United States
  • New Jersey
    • Freehold, New Jersey, United States
    • Toms River, New Jersey, United States
  • New York
    • Brooklyn, New York, United States
  • North Carolina
    • Charlotte, North Carolina, United States
    • Greenville, North Carolina, United States
    • Salisbury, North Carolina, United States
  • Ohio
    • Middleburg Heights, Ohio, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
    • Tulsa, Oklahoma, United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States
    • Wyomissing, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
    • Columbia, South Carolina, United States
    • Myrtle Beach, South Carolina, United States
    • Orangeburg, South Carolina, United States
  • Tennessee
    • Memphis, Tennessee, United States
  • Texas
    • Beaumont, Texas, United States
    • Corpus Christi, Texas, United States
    • Mesquite, Texas, United States
    • Plano, Texas, United States
    • San Antonio, Texas, United States
    • Webster, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• 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 Exclusion Criteria:

• Previous treatment with any janus kinase (JAK) inhibitor

NOTE: Other protocol Inclusion/ Exclusion criteria may apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Filgotinib 200 mg; Filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: 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)
Experimental: Filgotinib 100 mg; Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: 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)
Placebo Comparator: Placebo; Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)	Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Who Achieved an American College of Rheumatology (ACR) 20% Improvement (ACR20) Response at Week 12	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.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12	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).	Baseline; Week 12
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] ≤ 3.2 at Week 12	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.	Week 12
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12	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.	Baseline; Week 12
Percentage of Participants Who Achieved 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 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.	Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 12	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).	Baseline; Week 12
Percentage of Participants Who Achieved ACR 50% Improvement (ACR50) at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
Percentage of Participants Who Achieved ACR 70% Improvement (ACR70) at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
Percentage of Participants Who Achieved ACR20 Response at Weeks 4, and 24	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.	Weeks 4, and 24
Change From Baseline in Individual ACR Component: Tender Joint Count Based on 68 Joints (TJC68) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in Individual ACR Component: Swollen Joint Count Based on 66 Joints (SJC66) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in Individual ACR Component: Subject's Global Assessment of Disease Activity (SGA) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in Individual ACR Component: Physician's Global Assessment of Disease Activity (PGA) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in Individual ACR Component: Subject's Pain Assessment at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in Individual ACR Component: HAQ-DI at Weeks 4, and 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 (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.	Baseline; Weeks 4, and 24
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 4, 12, and 24		Baseline; Weeks 4, 12, and 24
Percentage of Participants Who Achieved an Improvement (Decrease) in the HAQ-DI Score ≥ 0.22 at Weeks 4, 12, and 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 (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.	Weeks 4, 12, and 24
Change From Baseline in DAS28 (CRP) at Weeks 4, 12, and 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), 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.	Baseline; Weeks 4, 12, and 24
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Weeks 4, and 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), 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.	Weeks 4, and 24
Percentage of Participants Who Achieved DAS28 (CRP) < 2.6 at Weeks 4, and 12	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.	Weeks 4, and 12
American College of Rheumatology N Percent Improvement (ACR-N) at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
Number of Participants With European League Against Rheumatism (EULAR) Response at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
Change From Baseline in Clinical Disease Activity Index (CDAI) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in Simplified Disease Activity Index (SDAI) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
SF-36 PCS Score at Weeks 4, 12, and 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.	Weeks 4, 12, and 24
Change From Baseline in SF-36 PCS Score at Weeks 4, and 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.	Baseline; Weeks 4, and 24
SF-36 Mental Component Summary (MCS) Score at Weeks 4, 12, and 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.	Weeks 4, 12, and 24
Change From Baseline in SF-36 MCS Score at Weeks 4, 12, and 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.	Baseline; Weeks 4, 12, and 24
FACIT-Fatigue Score at Weeks 4, 12, and 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 0 to 52.	Weeks 4, 12, and 24
Change From Baseline in FACIT-Fatigue Score at Weeks 4, and 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 0 to 52. Positive change in value indicates improvement (no or less severity of fatigue).	Baseline; Weeks 4, and 24
Number of Participants by European Quality of Life 5 Dimensions (EQ-5D) Health Profile Categories at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
EQ-5D Current Health VAS at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
Change From Baseline in EQ-5D Current Health VAS at Weeks 4, 12, and 24	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).	Baseline; Weeks 4, 12, and 24
Work Productivity and Activity Impairment-Rheumatoid Arthritis (WPAI-RA): Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24	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.	Weeks 4, 12, and 24
Change From Baseline in WPAI-RA: Mean Percentage of Work Time Missed (Absenteeism) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in WPAI-RA: Mean Percentage of Impairment While Working Due to RA (Presenteeism) at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in WPAI-RA: Mean Percentage of Overall Work Productivity Impairment Due to RA at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24
Change From Baseline in WPAI-RA: Mean Percentage of Activity Impairment Due to RA at Weeks 4, 12, and 24	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.	Baseline; Weeks 4, 12, and 24

Collaborators and Investigators

• Sponsor: Gilead Sciences
• Collaborators: Galapagos NV

Publications and helpful links

General Publications

• Combe B, Besuyen R, Gomez-Centeno A, Matsubara T, Sancho Jimenez JJ, Yin Z, Buch MH. Geographic Analysis of the Safety and Efficacy of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2022 Oct 7. doi: 10.1007/s40744-022-00494-1. Online ahead of print.
• Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.
• Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055. Erratum In: JAMA. 2020 Feb 4;323(5):480.
• Bingham CO 3rd, Walker D, Nash P, Lee SJ, Ye L, Hu H, Khalid JM, Combe B. The impact of filgotinib on patient-reported outcomes and health-related quality of life for patients with active rheumatoid arthritis: a post hoc analysis of Phase 3 studies. Arthritis Res Ther. 2022 Jan 3;24(1):11. doi: 10.1186/s13075-021-02677-7.
• Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, de Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2022 Jan 5;32(1):59-67. doi: 10.1080/14397595.2020.1859675.

Study record dates

Study Major Dates

• Study Start (Actual): July 27, 2016
• Primary Completion (Actual): March 20, 2018
• Study Completion (Actual): June 26, 2018

Study Registration Dates

• First Submitted: August 17, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 22, 2016

Study Record Updates

• Last Update Posted (Actual): May 13, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: GS-US-417-0302; 2016-000569-21 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No