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Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

Trial Profile

Randomized, Double-blind, Placebo-controlled, Multicenter, Phase IIb Dose Finding Study of GLPG0634 Administered for 24 Weeks in Combination With Methotrexate to Subjects With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate Alone

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 02 Jan 2024

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At a glance

  • Drugs Filgotinib (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms DARWIN-1
  • Sponsors Galapagos NV
  • Most Recent Events

    • 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.
    • 15 Nov 2023 Results of a post-hoc sub-group analysis reporting updated long-term safety and efficacy in 4 subgroups of patients with RA pooling data from following clinical trials (Phase 2: NCT01888874, NCT01894516, NCT02065700 and Phase 3: NCT02889796, NCT02873936, NCT02886728, NCT03025308) presented at the ACR Convergence 2023
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