Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
NCT ID: NCT02889796
Last Updated: 2021-06-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1759 participants
INTERVENTIONAL
2016-08-30
2019-06-20
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
Filgotinib 200 mg + placebo to match filgotinib 100 mg + placebo to match adalimumab 40 mg in addition to a stable dose of methotrexate (MTX)
Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg + placebo to match adalimumab 40 mg in addition to a stable dose of MTX
Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
Adalimumab
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + adalimumab 40 mg in addition to a stable dose of MTX
Placebo to match filgotinib
Tablet(s) administered orally once daily
Adalimumab
40 mg administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
Placebo to Filgotinib 200 mg
Placebo 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.
Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
Placebo to Filgotinib 100 mg
Placebo 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.
Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
Placebo Never Received Filgotinib
Placebo 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.
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
Interventions
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Filgotinib
200 mg or 100 mg tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Adalimumab
40 mg administered via subcutaneous injection once every two weeks
Placebo to match adalimumab
Administered via subcutaneous injection once every two weeks
MTX
Commercially sourced tablet(s) administered orally
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.
* Ongoing treatment with a stable dose of MTX
Exclusion Criteria
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
Hemet, California, United States
La Jolla, California, United States
Palm Desert, California, United States
Upland, California, United States
Victorville, California, United States
Whittier, California, United States
Clearwater, Florida, United States
DeBary, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
New Port Richey, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Cumberland, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Detroit, Michigan, 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
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Salisbury, North Carolina, United States
Bethlehem, Pennsylvania, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Orangeburg, South Carolina, United States
Memphis, Tennessee, United States
Beaumont, Texas, United States
Corpus Christi, Texas, United States
Dallas, Texas, United States
Mesquite, 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
Victoria Park, Western Australia, Australia
Brussels, , Belgium
Genk, , Belgium
Merksem, , Belgium
Dobrich, , Bulgaria
Haskovo, , Bulgaria
Plovdiv, , Bulgaria
Sofia, , Bulgaria
Varna, , Bulgaria
Vidin, , Bulgaria
Trois-Rivières, Quebec, Canada
Prague, Prague, Czechia
Brno, , Czechia
Ostrava, , Czechia
Ostrava-Poruba, , Czechia
Prague, , Czechia
Uherské Hradiště, , Czechia
Frankfurt A Main, , Germany
Hamburg, , Germany
Ratingen, , Germany
Hong Kong, , Hong Kong
Kalocsa, Bács-Kiskun county, Hungary
Szentes, Csongrád megye, Hungary
Székesfehérvár, Fejér, Hungary
Budapest, , Hungary
Eger, , Hungary
Ahmedabad, , India
Bangalore, , India
Chennai, , India
Delhi, , India
Gurgaon, , India
Hyderabad, , India
Jaipur, , India
Kolkata, , India
Lucknow, , India
Mangalore, , India
Nagpur, , India
New Delhi, , India
Pune, , India
Secunderabad, , India
Srikakulam, , India
Surat, , India
Vadodara, , India
Visakhapatnam, , India
Dublin, , Ireland
Haifa, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Bologna, , Italy
Catania, , Italy
Milan, , Italy
Chiba, , Japan
Fukuoka, , Japan
Hiroshima, , Japan
Iizuka-shi, , Japan
Iruma-gun, , Japan
Izumo, , Japan
Kagoshima, , Japan
Katō, , Japan
Kitakyushu-shi, , Japan
Kobe, , Japan
Kumamoto, , Japan
Kurume-shi, , Japan
Kyoto, , Japan
Miyazaki, , Japan
Morioka, , Japan
Nagaoka, , Japan
Nagasaki, , Japan
Nagoya, , Japan
Narashino, , Japan
Nishinomiya, , Japan
Ōita, , Japan
Sanuki-shi, , Japan
Sapporo, , Japan
Sasebo-shi, , Japan
Sayama-shi, , Japan
Shibata, , Japan
Shinjuku-Ku, , Japan
Shizuoka, , Japan
Suita-shi, , Japan
Takaoka, , Japan
Takasaki-shi, , Japan
Tokorozawa, , Japan
Tokyo, , Japan
Tsukuba, , Japan
Wakayama, , Japan
Yokohama, , Japan
Mérida, Yucatán, Mexico
Chihuahua City, , Mexico
Distrito Federal, , Mexico
Mexico City, , Mexico
Mérida, , Mexico
Monterrey, , Mexico
Morelia, , Mexico
Leiden, , Netherlands
Papatoetoe, Auckland, New Zealand
Auckland, , New Zealand
Hamilton, , New Zealand
Newtown, , New Zealand
Timaru, , New Zealand
Wroclaw, Lower Silesian Voivodeship, Poland
Bialystok, , Poland
Bydgoszcz, , Poland
Bytom, , Poland
Elblag, , Poland
Gdynia, , Poland
Kartuzy, , Poland
Katowice, , Poland
Krakow, , Poland
Nowa Sól, , Poland
Poznan, , Poland
Tomaszów Lubelski, , Poland
Torun, , Poland
Warsaw, , Poland
Oradea, Bihor County, Romania
Bucharest, București, Romania
Bacau, , Romania
Târgu Mureş, , Romania
Barnaul, , Russia
Chelyabinsk, , Russia
Kazan', , Russia
Kemerovo, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Saratov, , Russia
Vladimir, , Russia
Yaroslavl, , Russia
Belgrade, , Serbia
Niška Banja, , Serbia
Bratislava, , Slovakia
Prievidza, , Slovakia
Rimavská Sobota, , Slovakia
Topoľčany, , Slovakia
Cape Town, , South Africa
Durban, , South Africa
Johannesburg, , South Africa
Anyang-si, , South Korea
Busan, , South Korea
Daegu, , South Korea
Daejeon, , South Korea
Gwangju, , South Korea
Incheon, , South Korea
Jeonju, , South Korea
Seoul, , South Korea
A Coruña, , Spain
Málaga, , Spain
Sabadell, , Spain
Santiago de Compostela, , Spain
Valencia, , Spain
Changhua, , Taiwan
Kaohsiung City, , Taiwan
Keelung, , Taiwan
Taichung, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Songkhla, , Thailand
Dnipro, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kiev, , Ukraine
Kyiv, , Ukraine
Lutsk, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Vinnytsia, , Ukraine
Zaporizhzhya, , Ukraine
Poole, England, United Kingdom
Doncaster, , United Kingdom
Edinburgh, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Warrington, , United Kingdom
Countries
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References
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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.
Tanaka 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.
Buch 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.
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, 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.
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.
Combe 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000568-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-417-0301
Identifier Type: -
Identifier Source: org_study_id
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