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A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

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Trial Profile

A Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study to Assess the Efficacy and Safety of Filgotinib Administered for 24 Weeks in Combination With Conventional Synthetic Disease-modifying Anti-rheumatic Drug(s) (csDMARDs) to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Biologic DMARD(s) Treatment

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 19 Jul 2024

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At a glance

  • Drugs Filgotinib (Primary) ; Chloroquine; Disease-modifying antirheumatics; Hydroxychloroquine; Leflunomide; Methotrexate; Sulfasalazine
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms FINCH 2
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 15 Jun 2024 Results of pooled analysis from DARWIN 1-3 (NCT01888874, NCT01894516, NCT02065700) and FINCH 1-4 (NCT02889796, NCT02873936, NCT02886728, NCT03025308) trials providing an update on FIL selected AEs , presented at the 25th Annual Congress of the European League Against Rheumatism
    • 15 Nov 2023 Results of pooled analysis from DARWIN 1-3 (NCT01888874, NCT01894516, NCT02065700) and FINCH 1-4 (NCT02889796, NCT02873936, NCT02886728, NCT03025308) trials assessing the incidence of malignancies excluding nonmelanoma skin cancer (NMSC), NMSC, MACE and venous thromboembolism (VTE) in patients treated with FIL200 or FIL100, presented at the ACR Convergence 2023.
    • 15 Nov 2023 Results of integrated safety analysis of filgotinib in patients with moderate to severe active rheumatoid arthritis from 7 clinical trials NCT01888874, NCT01894516 NCT02889796, NCT02873936, NCT02886728, NCT02065700 & NCT03025308, presented at the ACR Convergence 2023.

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