drugset / Trial / NCT02889796
Filgotinib in Combination With Methotrexate in Adults With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2016-08-30
- Primary completion
- 2018-07-04
- Completion
- 2019-06-20
Outcome
Met primary endpoint
registry analysis (superiority test); Filgotinib 200 mg vs Placebo; p <0.001; Difference in Response Rates 26.7 (95% CI 20.6 to 32.8) NCT02889796 ↗
registry analysis (superiority test); Filgotinib 100 mg vs Placebo; p <0.001; Difference in Response Rates 19.9 (95% CI 13.6 to 26.2) NCT02889796 ↗
paper The proportion of patients (n=1755 randomised and treated) achieving ACR20 at week 12 was significantly higher for FIL200 (76.6%) and FIL100 (69.8%) versus placebo (49.9%; PMID 33504485 ↗
Publications
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | 40 mg | Subcutaneous |
| Subject | Filgotinib | Small molecule | 100 mg | Oral |
| Subject | Filgotinib | Small molecule | 200 mg | Oral |
| Background | Methotrexate | Small molecule | — | Oral |