Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy (FINCH 3)

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

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).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 1252
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
  • Caba, Argentina
  • Mendoza, Argentina
  • Quilmes, Argentina
  • San Fernando, Argentina
  • San Juan, Argentina
  • San Miguel de Tucumán, Argentina
• Australia
  • Queensland
    • Maroochydore, Queensland, Australia
  • Tasmania
    • Hobart, Tasmania, Australia
  • Western Australia
    • Victoria Park, Western Australia, Australia
• Belgium
  • Genk, Belgium
  • Hasselt, Belgium
  • Merksem, Belgium
  • Flemish Brabant
    • Leuven, Flemish Brabant, Belgium
• Bulgaria
  • Dobrich, Bulgaria
  • Haskovo, Bulgaria
  • Plovdiv, Bulgaria
  • Sofia, Bulgaria
  • Varna, Bulgaria
  • Vidin, Bulgaria
• Canada
  • Ontario
    • Barrie, Ontario, Canada
  • Quebec
    • Trois-Rivieres, Quebec, Canada
• Chile
  • Santiago, Chile
  • Temuco, Chile
• Czechia
  • Ostrava, Czechia
  • Prague 2, Czechia
  • Praha 4, Czechia
  • Uherske Hradiste, Czechia
• Germany
  • Aachen, Germany
  • Hamburg, Germany
  • Ratingen, Germany
• Hong Kong
  • Hong Kong, Hong Kong
  • Tuen Mun, Hong Kong
• Hungary
  • Budapest, Hungary
  • Kistarcsa, Hungary
  • Bacs-Kiskun
    • Kalocsa, Bacs-Kiskun, Hungary
  • Fejer
    • Székesfehérvár, Fejer, Hungary
• India
  • Ahmedabad, India
  • Bangalore, India
  • Delhi, India
  • Jaipur, India
  • Kolkata, India
  • Lucknow, India
  • Mangalore, India
  • Mysuru, India
  • Nagpur, India
  • New Delhi, India
  • Pune, India
  • Secunderabad, India
  • Srikakulam, India
  • Surat, India
  • Vadodara, India
  • Visakhapatnam, India
• Ireland
  • Dublin 4, Ireland
• Israel
  • Petaẖ Tiqwa, Israel
• Italy
  • Bologna, Italy
  • Reggio Emilia, Italy
• Japan
  • Fukuoka, Japan
  • Hamamatsu, Japan
  • Hiroshima, Japan
  • Kagoshima, Japan
  • Katō, Japan
  • Kawagoe, Japan
  • Miyagi, Japan
  • Nagaoka, Japan
  • Nagasaki, Japan
  • Okayama, Japan
  • Sanuki, Japan
  • Sapporo, Japan
  • Sasebo, Japan
  • Sayama, Japan
  • Tokyo, Japan
  • Ōme, Japan
• Korea, Republic of
  • Anyang-si, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Incheon, Korea, Republic of
  • Seoul, Korea, Republic of
• Malaysia
  • Batu Caves, Malaysia
  • Kuala Lumpur, Malaysia
• Mexico
  • Chihuahua, Mexico
  • Distrito Federal, Mexico
  • Monterrey, Mexico
  • Morelia, Mexico
  • Mérida, Mexico
  • Yucatan
    • Mérida, Yucatan, Mexico
• New Zealand
  • Hamilton, New Zealand
  • Newtown, New Zealand
  • Papatoetoe, New Zealand
  • Canterbury
    • Timaru, Canterbury, New Zealand
• Poland
  • Białystok, Poland
  • Bydgoszcz, Poland
  • Bytom, Poland
  • Dąbrówka, Poland
  • Elbląg, Poland
  • Gdynia, Poland
  • Katowice, Poland
  • Krakow, Poland
  • Nowa Sól, Poland
  • Poznan, Poland
  • Toruń, Poland
  • Warszawa, Poland
• Romania
  • Bucharest, Romania
  • Oradea, Romania
  • Mures
    • Targu Mures, Mures, Romania
• Russian Federation
  • Barnaul, Russian Federation
  • Kemerovo, Russian Federation
  • Moscow, Russian Federation
  • Nizhniy Novgorod, Russian Federation
  • Saratov, Russian Federation
  • Yaroslavl, Russian Federation
• Serbia
  • Belgrade, Serbia
• Slovakia
  • Bratislava, Slovakia
  • Prievidza, Slovakia
  • Topol'cany, Slovakia
• South Africa
  • Cape Town, South Africa
  • Durban, South Africa
• Spain
  • Barakaldo, Spain
  • La Coruña, Spain
  • Málaga, Spain
  • Sabadell, Spain
  • Santiago de Compostela, Spain
  • Valencia, Spain
  • Barcelona
    • Sabadell, Barcelona, Spain
• Taiwan
  • Kaohsiung, Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taipei, Taiwan
  • Taoyuan, Taiwan
• Thailand
  • Bangkok, Thailand
  • Chiang Mai, Thailand
  • Songkhla, Thailand
• Ukraine
  • Dnipro, Ukraine
  • Kharkiv, Ukraine
  • Kherson, Ukraine
  • Kyiv, Ukraine
  • L'viv, Ukraine
  • Vinnitsa, Ukraine
  • Vinnytsya, Ukraine
  • Zaporizhzhya, Ukraine
• United Kingdom
  • Edinburgh, United Kingdom
  • Newcastle upon Tyne, United Kingdom
• United States
  • Alabama
    • Huntsville, Alabama, United States
  • Arizona
    • Phoenix, Arizona, United States
    • Tucson, Arizona, United States
  • California
    • Covina, California, United States
    • Los Angeles, California, United States
    • Palm Desert, California, United States
    • Victorville, California, United States
    • Whittier, California, United States
  • Florida
    • DeBary, Florida, United States
    • Jacksonville, Florida, United States
    • Miami, Florida, United States
    • Orlando, Florida, United States
    • Plantation, Florida, United States
  • Illinois
    • Springfield, Illinois, United States
  • Kansas
    • Wichita, Kansas, United States
  • Kentucky
    • Elizabethtown, Kentucky, United States
  • Maryland
    • Cumberland, Maryland, United States
    • Wheaton, Maryland, United States
  • Massachusetts
    • Worcester, Massachusetts, United States
  • Michigan
    • Saint Clair Shores, Michigan, United States
  • Minnesota
    • Eagan, Minnesota, 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 Mexico
    • Albuquerque, New Mexico, United States
  • North Carolina
    • Charlotte, North Carolina, United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States
    • Tulsa, Oklahoma, United States
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States
    • Duncansville, Pennsylvania, United States
    • Wyomissing, Pennsylvania, United States
  • South Carolina
    • Charleston, South Carolina, United States
    • Orangeburg, South Carolina, United States
  • Tennessee
    • Memphis, Tennessee, United States
  • Texas
    • Beaumont, Texas, United States
    • Carrollton, 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: 18 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) 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 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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Filgotinib 200 mg + MTX; Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: MTX; Capsule(s) administered orally once weekly
EXPERIMENTAL: Filgotinib 100 mg + MTX; Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: MTX; Capsule(s) administered orally once weekly
EXPERIMENTAL: Filgotinib 200 mg Monotherapy; Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX	Drug: Filgotinib; Tablet(s) administered orally once daily; Other Names: GS-6034; GLPG0634; Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: Placebo to match MTX; Capsule(s) administered orally once weekly
ACTIVE_COMPARATOR: MTX Monotherapy; Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg	Drug: Placebo to match filgotinib; Tablet(s) administered orally once daily; Drug: MTX; Capsule(s) administered orally once weekly

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 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.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline; Week 24
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.	Week 24
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).	Baseline; Week 24
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.	Baseline; Week 24
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).	Baseline; Week 24
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).	Baseline; Week 52
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.	Weeks 2, 4, 12, 36, and 52
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.	Weeks 2, 4, 12, 24, 36, and 52
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.	Weeks 2, 4, 12, 24, 36, and 52
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).	Baseline; Weeks 2, 4, 12, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
Change From Baseline in Individual ACR Component: High-Sensitivity C-Reactive Protein (hsCRP) at Weeks 2, 4, 12, 24, 36, and 52		Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, and 52
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.	Weeks 2, 4, 12, 36, and 52
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.	Weeks 2, 4, 12, 24, 36, and 52
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.	Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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.	Baseline; Weeks 2, 4, 12, 24, 36, and 52
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).	Baseline; Weeks 24, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Baseline; Weeks 4, 12, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Baseline; Weeks 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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).	Baseline; Weeks 4, 12, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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).	Baseline; Weeks 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Weeks 4, 12, 24, 36, and 52
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.	Baseline; Weeks 4, 12, 24, 36, and 52
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.	Baseline; Weeks 4, 12, 24, 36, and 52
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.	Baseline; Weeks 4, 12, 24, 36, and 52
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.	Baseline; Weeks 4, 12, 24, 36, and 52

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.
• Westhovens R, Rigby W, van der Heijde D, Ching D, Bartok B, Matzkies F, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis naive to methotrexate therapy: FINCH 3 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2): A259.
• Tanaka Y, Atsumi T, Aletaha D, Bartok B, Pechonkina A, Han L, Emoto K, Kano S, Rajendran V, Takeuchi T. Benefit of Filgotinib, a JAK1 Preferential Inhibitor, in Rheumatoid Arthritis Patients with Previous Rapid Radiographic Progression: Post Hoc Analysis of Two Trials. Rheumatol Ther. 2022 Nov 3. doi: 10.1007/s40744-022-00503-3. Online ahead of print.
• 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.
• Aletaha D, Westhovens R, Gaujoux-Viala C, Adami G, Matsumoto A, Bird P, Messina OD, Buch MH, Bartok B, Yin Z, Guo Y, Hendrikx T, Burmester GR. Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3. RMD Open. 2021 Aug;7(2):e001621. doi: 10.1136/rmdopen-2021-001621.
• Westhovens R, Rigby WFC, van der Heijde D, Ching DWT, Stohl W, Kay J, Chopra A, Bartok B, Matzkies F, Yin Z, Guo Y, Tasset C, Sundy JS, Jahreis A, Mozaffarian N, Messina OD, Landewe RB, Atsumi T, Burmester GR. Filgotinib in combination with methotrexate or as monotherapy versus methotrexate monotherapy in patients with active rheumatoid arthritis and limited or no prior exposure to methotrexate: the phase 3, randomised controlled FINCH 3 trial. Ann Rheum Dis. 2021 Jun;80(6):727-738. doi: 10.1136/annrheumdis-2020-219213. Epub 2021 Jan 15.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 8, 2016
• Primary Completion (ACTUAL): October 5, 2018
• Study Completion (ACTUAL): May 8, 2019

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: August 29, 2016
• First Posted (ESTIMATE): September 1, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 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-417-0303; 2016-000570-37 (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