Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
FINCH 1
A Randomized, Double-blind, Placebo- and Active-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 52 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
2 other identifiers
interventional
1,759
30 countries
230
Brief Summary
The primary objective of this study is to evaluate the effects of filgotinib versus placebo for the treatment of signs and symptoms of rheumatoid arthritis (RA) as measured by the percentage of participants achieving an American College of Rheumatology 20% improvement response (ACR20) at Week 12.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 rheumatoid-arthritis
Started Aug 2016
Typical duration for phase_3 rheumatoid-arthritis
230 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 30, 2016
CompletedFirst Submitted
Initial submission to the registry
August 31, 2016
CompletedFirst Posted
Study publicly available on registry
September 7, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 4, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2019
CompletedResults Posted
Study results publicly available
January 19, 2021
CompletedJune 9, 2021
May 1, 2021
1.8 years
August 31, 2016
December 21, 2020
May 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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)participant's pain assessment using VAS on a scale of 0-100 (0 and 100 indicating no pain and unbearable pain) health assessment questionnaire-disability index (HAQ-DI) score contains 20 questions,8 components: dressing/ grooming, arising, eating, walking, hygiene, reach, grip and activities and scored on a scale of 0-3 (0 and 3 indicating without difficulty and unable to do); high-sensitivity C-reactive protein (hsCRP). Participants with missing outcomes were set as non-responders.
Week 12
Secondary Outcomes (79)
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 12
Baseline; Week 12
Percentage of Participants Who Achieved Disease Activity Score for 28 Joint Count Using C-Reactive Protein [DAS28 (CRP)] < 2.6 at Week 12
Week 12
Change From Baseline in Modified Total Sharp Score (mTSS) at Week 24
Baseline; Week 24
Percentage of Participants Who Achieved DAS28 (CRP) ≤ 3.2 at Week 12
Week 12
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 12
Baseline; Week 12
- +74 more secondary outcomes
Study Arms (6)
Filgotinib 200 mg
EXPERIMENTALFilgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)
Filgotinib 100 mg
EXPERIMENTALFilgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX
Adalimumab
ACTIVE COMPARATORPlacebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX
Placebo to Filgotinib 200 mg
EXPERIMENTALPlacebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 200 mg to receive filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.
Placebo to Filgotinib 100 mg
EXPERIMENTALPlacebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks. After 24 weeks, participants will be rerandomized to filgotinib 100 mg to receive filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX.
Placebo Never Received Filgotinib
PLACEBO COMPARATORPlacebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX for up to 24 weeks.
Interventions
200 mg or 100 mg tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Administered via subcutaneous injection once every two weeks
Commercially sourced tablet(s) administered orally
Eligibility Criteria
You may qualify if:
- Have a diagnosis of rheumatoid arthritis (RA) \[2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria\] , and are ACR functional class I-III.
- Have ≥ 6 swollen joints (from a swollen joint count based on 66 joints (SJC66)) and ≥ 6 tender joints (from a tender joint count based on 68 joints (TJC68)) at both screening and Day 1.
- Ongoing treatment with a stable dose of MTX
You may not qualify if:
- Previous treatment with any janus kinase (JAK) inhibitor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Galapagos NVcollaborator
Study Sites (230)
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Huntsville, Alabama, United States
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Covina, California, United States
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Hemet, California, United States
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La Jolla, California, United States
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Palm Desert, California, United States
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Upland, California, United States
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Victorville, California, United States
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Whittier, California, United States
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Clearwater, Florida, United States
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DeBary, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Plantation, Florida, United States
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Kansas City, Kansas, United States
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Wichita, Kansas, United States
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Elizabethtown, Kentucky, United States
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Lexington, Kentucky, United States
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Cumberland, Maryland, United States
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Hagerstown, Maryland, United States
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Wheaton, Maryland, United States
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Detroit, Michigan, United States
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Saint Clair Shores, Michigan, United States
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Eagan, Minnesota, United States
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Hattiesburg, Mississippi, United States
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Tupelo, Mississippi, United States
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St Louis, Missouri, United States
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Toms River, New Jersey, United States
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Albuquerque, New Mexico, United States
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Salisbury, North Carolina, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Charleston, South Carolina, United States
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Columbia, South Carolina, United States
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Orangeburg, South Carolina, United States
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Memphis, Tennessee, United States
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Beaumont, Texas, United States
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Corpus Christi, Texas, United States
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Dallas, Texas, United States
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Mesquite, Texas, United States
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San Antonio, Texas, United States
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Webster, Texas, United States
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Buenos Aires, Argentina
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Caba, Argentina
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Mendoza, Argentina
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Quilmes, Argentina
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San Fernando, Argentina
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San Juan, Argentina
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San Miguel de Tucumán, Argentina
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Victoria Park, Western Australia, Australia
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Brussels, Belgium
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Genk, Belgium
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Merksem, Belgium
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Dobrich, Bulgaria
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Haskovo, Bulgaria
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Plovdiv, Bulgaria
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Sofia, Bulgaria
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Varna, Bulgaria
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Vidin, Bulgaria
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Trois-Rivières, Quebec, Canada
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Prague, Prague, Czechia
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Brno, Czechia
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Ostrava, Czechia
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Ostrava-Poruba, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Frankfurt A Main, Germany
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Hamburg, Germany
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Ratingen, Germany
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Hong Kong, Hong Kong
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Kalocsa, Bács-Kiskun county, Hungary
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Szentes, Csongrád megye, Hungary
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Székesfehérvár, Fejér, Hungary
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Budapest, Hungary
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Eger, Hungary
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Ahmedabad, India
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Bangalore, India
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Chennai, India
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Delhi, India
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Gūrgaon, India
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Hyderabad, India
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Jaipur, India
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Kolkata, India
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Lucknow, India
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Mangalore, India
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Nagpur, India
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New Delhi, India
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Pune, India
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Secunderabad, India
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Srikakulam, India
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Surat, India
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Vadodara, India
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Visakhapatnam, India
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Dublin, Ireland
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Haifa, Israel
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Tel Aviv, Israel
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Tel Litwinsky, Israel
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Bologna, Italy
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Catania, Italy
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Milan, Italy
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Chiba, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Iizuka-shi, Japan
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Iruma-gun, Japan
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Izumo, Japan
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Kagoshima, Japan
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Katō, Japan
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Kitakyushu-shi, Japan
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Kobe, Japan
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Kumamoto, Japan
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Kurume-shi, Japan
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Kyoto, Japan
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Miyazaki, Japan
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Morioka, Japan
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Nagaoka, Japan
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Nagasaki, Japan
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Nagoya, Japan
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Narashino, Japan
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Nishinomiya, Japan
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Ōita, Japan
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Sanuki-shi, Japan
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Sapporo, Japan
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Sasebo-shi, Japan
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Sayama-shi, Japan
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Shibata, Japan
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Shinjuku-Ku, Japan
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Shizuoka, Japan
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Suita-shi, Japan
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Takaoka, Japan
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Takasaki-shi, Japan
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Tokorozawa, Japan
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Tokyo, Japan
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Tsukuba, Japan
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Wakayama, Japan
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Yokohama, Japan
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Mérida, Yucatán, Mexico
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Chihuahua City, Mexico
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Distrito Federal, Mexico
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Mexico City, Mexico
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Mérida, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Leiden, Netherlands
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Papatoetoe, Auckland, New Zealand
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Auckland, New Zealand
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Hamilton, New Zealand
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Newtown, New Zealand
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Timaru, New Zealand
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Wroclaw, Lower Silesian Voivodeship, Poland
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Bialystok, Poland
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Bydgoszcz, Poland
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Bytom, Poland
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Elblag, Poland
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Gdynia, Poland
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Kartuzy, Poland
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Katowice, Poland
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Krakow, Poland
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Nowa Sól, Poland
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Poznan, Poland
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Tomaszów Lubelski, Poland
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Torun, Poland
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Warsaw, Poland
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Oradea, Bihor County, Romania
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Bucharest, București, Romania
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Bacau, Romania
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Târgu Mureş, Romania
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Barnaul, Russia
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Chelyabinsk, Russia
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Kazan', Russia
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Kemerovo, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Vladimir, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Niška Banja, Serbia
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Bratislava, Slovakia
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Prievidza, Slovakia
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Rimavská Sobota, Slovakia
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Topoľčany, Slovakia
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Cape Town, South Africa
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Durban, South Africa
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Johannesburg, South Africa
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Anyang-si, South Korea
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Busan, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Gwangju, South Korea
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Incheon, South Korea
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Jeonju, South Korea
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Seoul, South Korea
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A Coruña, Spain
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Málaga, Spain
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Sabadell, Spain
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Santiago de Compostela, Spain
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Valencia, Spain
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Changhua, Taiwan
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Kaohsiung City, Taiwan
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Keelung, Taiwan
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Taichung, Taiwan
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Tainan, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Bangkok, Thailand
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Chiang Mai, Thailand
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Songkhla, Thailand
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Dnipro, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kiev, Ukraine
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Kyiv, Ukraine
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Lutsk, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Poole, England, United Kingdom
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Doncaster, United Kingdom
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Edinburgh, United Kingdom
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Newcastle upon Tyne, United Kingdom
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Warrington, United Kingdom
Related Publications (11)
Combe B, Kivitz A, Tanaka Y, van der Heijde D, Matzkies F, Bartok B, et al. Efficacy and safety of filgotinib for patients with rheumatoid arthritis with inadequate response to methotrexate: FINCH 1 primary outcome results. Ann Rheum Dis 2019; 78 (supplement 2):A77.
RESULTTanaka Y, Atsumi T, Aletaha D, Schulze-Koops H, Fukada H, Watson C, Takeuchi T. The Uncoupling of Disease Activity from Joint Structural Progression in Patients with Rheumatoid Arthritis Treated with Filgotinib. Rheumatol Ther. 2025 Feb;12(1):53-66. doi: 10.1007/s40744-024-00725-7. Epub 2024 Nov 26.
PMID: 39592547DERIVEDBuch MH, Walker D, Edwards CJ, Barry J, Akroyd L, Ekoka Omoruyi EV, Taylor PC. Efficacy and safety of filgotinib in patients with moderately active rheumatoid arthritis and an inadequate response to methotrexate. Rheumatology (Oxford). 2025 Apr 1;64(4):1661-1671. doi: 10.1093/rheumatology/keae486.
PMID: 39331638DERIVEDTaylor PC, Downie B, Han L, Hawtin R, Hertz A, Moots RJ, Takeuchi T. Patients with High Baseline Neutrophil-to-Lymphocyte Ratio Exhibit Better Response to Filgotinib as Treatment for Rheumatoid Arthritis. Rheumatol Ther. 2024 Oct;11(5):1383-1392. doi: 10.1007/s40744-024-00695-w. Epub 2024 Jul 10.
PMID: 38985247DERIVEDCurtis JR, Emery P, Downie B, Zhong Y, Liu J, Han L, Hawtin RE, Burmester GR. Filgotinib Demonstrates Efficacy in Rheumatoid Arthritis Independent of Smoking Status: Post Hoc Analysis of Phase 3 Trials and Claims-Based Analysis. Rheumatol Ther. 2024 Feb;11(1):177-189. doi: 10.1007/s40744-023-00619-0. Epub 2023 Dec 6.
PMID: 38057656DERIVEDBalsa A, Wassenberg S, Tanaka Y, Tournadre A, Orzechowski HD, Rajendran V, Lendl U, Stiers PJ, Watson C, Caporali R, Galloway J, Verschueren P. Effect of Filgotinib on Body Mass Index (BMI) and Effect of Baseline BMI on the Efficacy and Safety of Filgotinib in Rheumatoid Arthritis. Rheumatol Ther. 2023 Dec;10(6):1555-1574. doi: 10.1007/s40744-023-00599-1. Epub 2023 Sep 25.
PMID: 37747626DERIVEDTanaka Y, Taylor PC, Elboudwarej E, Hertz A, Shao X, Malkov VA, Matsushima H, Emoto K, Downie B, Takeuchi T. Filgotinib Modulates Inflammation-Associated Peripheral Blood Protein Biomarkers in Adults with Active Rheumatoid Arthritis and Prior Inadequate Response to Methotrexate. Rheumatol Ther. 2023 Oct;10(5):1335-1348. doi: 10.1007/s40744-023-00583-9. Epub 2023 Jul 25.
PMID: 37490202DERIVEDTanaka 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. 2023 Feb;10(1):161-185. doi: 10.1007/s40744-022-00503-3. Epub 2022 Nov 3.
PMID: 36327094DERIVEDCombe 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. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.
PMID: 36205910DERIVEDBingham 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.
PMID: 34980223DERIVEDCombe B, Kivitz A, Tanaka Y, van der Heijde D, Simon JA, Baraf HSB, Kumar U, Matzkies F, Bartok B, Ye L, Guo Y, Tasset C, Sundy JS, Jahreis A, Genovese MC, Mozaffarian N, Landewe RBM, Bae SC, Keystone EC, Nash P. Filgotinib versus placebo or adalimumab in patients with rheumatoid arthritis and inadequate response to methotrexate: a phase III randomised clinical trial. Ann Rheum Dis. 2021 Jul;80(7):848-858. doi: 10.1136/annrheumdis-2020-219214. Epub 2021 Jan 27.
PMID: 33504485DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gilead Clinical Study Information Center
- Organization
- Gilead Sciences
Study Officials
- STUDY DIRECTOR
Gilead Study Director
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2016
First Posted
September 7, 2016
Study Start
August 30, 2016
Primary Completion
July 4, 2018
Study Completion
June 20, 2019
Last Updated
June 9, 2021
Results First Posted
January 19, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share