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
2 other identifiers
interventional
1,252
31 countries
186
Brief Summary
The primary objective of this study is to evaluate the effects of filgotinib in combination with methotrexate (MTX) versus MTX alone in adults with active rheumatoid arthritis (RA).
Trial 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
186 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 8, 2016
CompletedFirst Submitted
Initial submission to the registry
August 29, 2016
CompletedFirst Posted
Study publicly available on registry
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 8, 2019
CompletedResults Posted
Study results publicly available
January 15, 2021
CompletedJune 1, 2021
May 1, 2021
2.2 years
August 29, 2016
December 21, 2020
May 5, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (42)
Change From Baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI) Score at Week 24
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
Week 24
Change From Baseline in the Modified Total Sharp Score (mTSS) at Week 24
Baseline; Week 24
Change From Baseline in 36-Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 24
Baseline; Week 24
Change From Baseline in Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Score at Week 24
Baseline; Week 24
- +37 more secondary outcomes
Study Arms (4)
Filgotinib 200 mg + MTX
EXPERIMENTALFilgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Filgotinib 100 mg + MTX
EXPERIMENTALFilgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg
Filgotinib 200 mg Monotherapy
EXPERIMENTALFilgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX
MTX Monotherapy
ACTIVE COMPARATORPlacebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Interventions
Tablet(s) administered orally once daily
Tablet(s) administered orally once daily
Capsule(s) administered orally once weekly
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Galapagos NVcollaborator
Study Sites (186)
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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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Los Angeles, California, United States
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Palm Desert, California, United States
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Victorville, California, United States
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Whittier, California, 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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Orlando, Florida, United States
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Plantation, Florida, United States
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Springfield, Illinois, United States
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Wichita, Kansas, United States
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Elizabethtown, Kentucky, United States
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Cumberland, Maryland, United States
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Wheaton, Maryland, United States
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Worcester, Massachusetts, 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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Lincoln, Nebraska, United States
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Lebanon, New Hampshire, United States
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Freehold, New Jersey, 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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Charlotte, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bethlehem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Wyomissing, Pennsylvania, United States
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Charleston, 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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Carrollton, Texas, United States
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Corpus Christi, Texas, United States
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Mesquite, Texas, United States
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Plano, 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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Maroochydore, Queensland, Australia
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Hobart, Tasmania, Australia
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Victoria Park, Western Australia, Australia
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Leuven, Flemish Brabant, Belgium
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Genk, Belgium
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Hasselt, 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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Barrie, Ontario, Canada
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Trois-Rivières, Quebec, Canada
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Santiago, Chile
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Temuco, Chile
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Ostrava, Czechia
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Prague, Czechia
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Uherské Hradiště, Czechia
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Aachen, 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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Tuenmen, Hong Kong
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Kalocsa, Bács-Kiskun county, Hungary
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Székesfehérvár, Fejér, Hungary
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Budapest, Hungary
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Kistarcsa, Hungary
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Ahmedabad, India
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Bangalore, India
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Delhi, 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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Mysuru, 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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Petah Tikva, Israel
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Bologna, Italy
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Reggio Emilia, Italy
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Fukuoka, Japan
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Hamamatsu, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Katō, Japan
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Kawagoe, Japan
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Miyagi, Japan
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Nagaoka, Japan
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Nagasaki, Japan
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Okayama, Japan
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Ōme, Japan
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Sanuki, Japan
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Sapporo, Japan
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Sasebo, Japan
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Sayama, Japan
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Tokyo, Japan
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Batu Caves, Malaysia
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Kuala Lumpur, Malaysia
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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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Mérida, Mexico
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Monterrey, Mexico
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Morelia, Mexico
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Timaru, Canterbury, New Zealand
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Hamilton, New Zealand
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Newtown, New Zealand
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Papatoetoe, New Zealand
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Bialystok, Poland
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Bydgoszcz, Poland
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Bytom, Poland
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Dąbrówka, Poland
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Elblag, Poland
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Gdynia, 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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Torun, Poland
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Warsaw, Poland
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Târgu Mureş, Mureș County, Romania
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Bucharest, Romania
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Oradea, Romania
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Barnaul, Russia
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Kemerovo, Russia
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Moscow, Russia
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Nizhny Novgorod, Russia
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Saratov, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Bratislava, Slovakia
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Prievidza, 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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Anyang-si, South Korea
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Daegu, South Korea
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Daejeon, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Sabadell, Barcelona, Spain
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A Coruña, Spain
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Barakaldo, 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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Kaohsiung City, 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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Kyiv, Ukraine
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Lviv, Ukraine
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Vinnitsa, Ukraine
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Vinnytsia, Ukraine
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Zaporizhzhya, Ukraine
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Edinburgh, United Kingdom
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Newcastle upon Tyne, United Kingdom
Related Publications (9)
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.
RESULTTaylor 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, 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: 34980223DERIVEDAletaha 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.
PMID: 34385364DERIVEDWesthovens 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.
PMID: 33452004DERIVED
MeSH Terms
Conditions
Interventions
Condition 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 29, 2016
First Posted
September 1, 2016
Study Start
August 8, 2016
Primary Completion
October 5, 2018
Study Completion
May 8, 2019
Last Updated
June 1, 2021
Results First Posted
January 15, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share