Filgotinib Versus Placebo in Adults With Active Rheumatoid Arthritis (RA) Who Have an Inadequate Response to Biologic Disease-modifying Anti-rheumatic Drug(s) (DMARDs) Treatment
NCT ID: NCT02873936
Last Updated: 2021-05-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
449 participants
INTERVENTIONAL
2016-07-27
2018-06-26
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 + stable dose of permitted csDMARD(s)
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
csDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
Filgotinib 100 mg
Filgotinib 100 mg + placebo to match filgotinib 200 mg + stable dose of permitted csDMARD(s)
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
csDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
Placebo
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg + stable dose of permitted csDMARD(s)
Placebo to match filgotinib
Tablet(s) administered orally once daily
csDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
Interventions
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Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
csDMARDs
csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
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 screening and Day 1
* Ongoing treatment with a stable prescription of 1 or 2 csDMARDs
* Have received at least one biologic disease modifying antirheumatic drug (bDMARD) for the treatment of RA to which they have had an inadequate response or intolerance
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
Gilbert, Arizona, United States
Covina, California, United States
Hemet, California, United States
La Jolla, California, United States
Palm Desert, California, United States
Palo Alto, California, United States
Riverside, California, United States
Upland, California, United States
Victorville, California, United States
Whittier, California, United States
Aventura, Florida, United States
DeBary, Florida, United States
Jacksonville, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Port Richey, Florida, United States
Decatur, Georgia, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Elizabethtown, Kentucky, United States
Lexington, Kentucky, United States
Cumberland, Maryland, United States
Frederick, Maryland, United States
Worcester, Massachusetts, United States
Detroit, Michigan, United States
Saint Clair Shores, Michigan, 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
Brooklyn, New York, United States
Charlotte, North Carolina, United States
Greenville, North Carolina, United States
Salisbury, North Carolina, United States
Middleburg Heights, Ohio, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Myrtle Beach, South Carolina, United States
Orangeburg, South Carolina, United States
Memphis, Tennessee, United States
Beaumont, 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
San Juan, , Argentina
Victoria Park, Western Australia, Australia
Ghent, , Belgium
Leuven, , Belgium
Merksem, , Belgium
Montpellier, , France
Berlin, , Germany
Hamburg, , Germany
Ratingen, , Germany
Budapest, , Hungary
Gyula, , Hungary
Székesfehérvár, , Hungary
Haifa, , Israel
Ramat Gan, , Israel
Hiroshima, , Japan
Izumo, , Japan
Katō, , Japan
Kawagoe, , Japan
Kumamoto, , Japan
Narashino, , Japan
Okayama, , Japan
Sagamihara, , Japan
Sapporo, , Japan
Shinjuku-Ku, , Japan
Takaoka, , Japan
Takasaki, , Japan
Tokorozawa, , Japan
Tokyo, , Japan
Tomigusuku, , Japan
Chihuahua City, , Mexico
Distrito Federal, , Mexico
Mérida, , Mexico
Bialystok, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Seoul, , South Korea
Madrid, , Spain
Málaga, , Spain
Sabadell, , Spain
Valencia, , Spain
Sankt Gallen, , Switzerland
Doncaster, , United Kingdom
Edinburgh, , United Kingdom
Goodmayes, , United Kingdom
Harlow, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Genovese MC, Kalunian KC, Walker D, Gottenberg JE, De Vlam K, Mozaffarian N, et al. Safety and Efficacy of Filgotinib in a Phase 3 Trial of Patients with Active Rheumatoid Arthritis and Inadequate Response or Intolerance to Biologic Dmards [Abstract No. L06]. ACR/ARHP Annual Meeting; 2018 19-24 October; Chicago, IL, USA.
Genovese MC, Kalunian K, Gottenberg JE, Mozaffarian N, Bartok B, Matzkies F, Gao J, Guo Y, Tasset C, Sundy JS, de Vlam K, Walker D, Takeuchi T. Effect of Filgotinib vs Placebo on Clinical Response in Patients With Moderate to Severe Rheumatoid Arthritis Refractory to Disease-Modifying Antirheumatic Drug Therapy: The FINCH 2 Randomized Clinical Trial. JAMA. 2019 Jul 23;322(4):315-325. doi: 10.1001/jama.2019.9055.
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.
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.
Takeuchi T, Matsubara T, Atsumi T, Amano K, Ishiguro N, Sugiyama E, Yamaoka K, Genovese MC, Kalunian K, Walker D, Gottenberg JE, de Vlam K, Bartok B, Pechonkina A, Kondo A, Gao J, Guo Y, Tasset C, Sundy JS, Tanaka Y. Efficacy and safety of filgotinib in Japanese patients with refractory rheumatoid arthritis: Subgroup analyses of a global phase 3 study (FINCH 2). Mod Rheumatol. 2022 Jan 5;32(1):59-67. doi: 10.1080/14397595.2020.1859675.
Provided Documents
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Document Type: Study Protocol: Amendment 1
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-000569-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-417-0302
Identifier Type: -
Identifier Source: org_study_id
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