Filgotinib Alone and in Combination With Methotrexate (MTX) in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Are Naive to MTX Therapy
NCT ID: NCT02886728
Last Updated: 2021-06-01
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1252 participants
INTERVENTIONAL
2016-08-08
2019-05-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Filgotinib 200 mg + MTX
Filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
MTX
Capsule(s) administered orally once weekly
Filgotinib 100 mg + MTX
Filgotinib 100 mg + placebo to match filgotinib 200 mg + MTX up to 20 mg
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
MTX
Capsule(s) administered orally once weekly
Filgotinib 200 mg Monotherapy
Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match MTX
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo to match MTX
Capsule(s) administered orally once weekly
MTX Monotherapy
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + MTX up to 20 mg
Placebo to match filgotinib
Tablet(s) administered orally once daily
MTX
Capsule(s) administered orally once weekly
Interventions
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Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
MTX
Capsule(s) administered orally once weekly
Placebo to match MTX
Capsule(s) administered orally once weekly
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Huntsville, Alabama, United States
Phoenix, Arizona, United States
Tucson, Arizona, United States
Covina, California, United States
Los Angeles, California, United States
Palm Desert, California, United States
Victorville, California, United States
Whittier, California, United States
DeBary, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Springfield, Illinois, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Cumberland, Maryland, United States
Wheaton, Maryland, United States
Worcester, Massachusetts, United States
Saint Clair Shores, Michigan, United States
Eagan, Minnesota, United States
Hattiesburg, Mississippi, United States
Tupelo, Mississippi, United States
St Louis, Missouri, United States
Lincoln, Nebraska, United States
Lebanon, New Hampshire, United States
Freehold, New Jersey, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Charlotte, North Carolina, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Orangeburg, South Carolina, United States
Memphis, Tennessee, United States
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
Buenos Aires, , Argentina
Caba, , Argentina
Mendoza, , Argentina
Quilmes, , Argentina
San Fernando, , Argentina
San Juan, , Argentina
San Miguel de Tucumán, , Argentina
Maroochydore, Queensland, Australia
Hobart, Tasmania, Australia
Victoria Park, Western Australia, Australia
Leuven, Flemish Brabant, Belgium
Genk, , Belgium
Hasselt, , Belgium
Merksem, , Belgium
Dobrich, , Bulgaria
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vidin, , Bulgaria
Barrie, Ontario, Canada
Trois-Rivières, Quebec, Canada
Santiago, , Chile
Temuco, , Chile
Ostrava, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Aachen, , Germany
Hamburg, , Germany
Ratingen, , Germany
Hong Kong, , Hong Kong
Tuenmen, , Hong Kong
Kalocsa, Bács-Kiskun county, Hungary
Székesfehérvár, Fejér, Hungary
Budapest, , Hungary
Kistarcsa, , Hungary
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
Dublin, , Ireland
Petah Tikva, , Israel
Bologna, , Italy
Reggio Emilia, , Italy
Fukuoka, , Japan
Hamamatsu, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Katō, , Japan
Kawagoe, , Japan
Miyagi, , Japan
Nagaoka, , Japan
Nagasaki, , Japan
Okayama, , Japan
Ōme, , Japan
Sanuki, , Japan
Sapporo, , Japan
Sasebo, , Japan
Sayama, , Japan
Tokyo, , Japan
Batu Caves, , Malaysia
Kuala Lumpur, , Malaysia
Mérida, Yucatán, Mexico
Chihuahua City, , Mexico
Distrito Federal, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Morelia, , Mexico
Timaru, Canterbury, New Zealand
Hamilton, , New Zealand
Newtown, , New Zealand
Papatoetoe, , New Zealand
Bialystok, , Poland
Bydgoszcz, , Poland
Bytom, , Poland
Dąbrówka, , Poland
Elblag, , Poland
Gdynia, , Poland
Katowice, , Poland
Krakow, , Poland
Nowa Sól, , Poland
Poznan, , Poland
Torun, , Poland
Warsaw, , Poland
Târgu Mureş, Mureș County, Romania
Bucharest, , Romania
Oradea, , Romania
Barnaul, , Russia
Kemerovo, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saratov, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Bratislava, , Slovakia
Prievidza, , Slovakia
Topoľčany, , Slovakia
Cape Town, , South Africa
Durban, , South Africa
Anyang-si, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Sabadell, Barcelona, Spain
A Coruña, , Spain
Barakaldo, , Spain
Málaga, , Spain
Sabadell, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Songkhla, , Thailand
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kyiv, , Ukraine
Lviv, , Ukraine
Vinnitsa, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Edinburgh, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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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.
Taylor 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.
Curtis 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.
Balsa 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.
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. 2023 Feb;10(1):161-185. doi: 10.1007/s40744-022-00503-3. Epub 2022 Nov 3.
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. 2023 Feb;10(1):35-51. doi: 10.1007/s40744-022-00494-1. Epub 2022 Oct 7.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000570-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-417-0303
Identifier Type: -
Identifier Source: org_study_id
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