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

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

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 22 Jul 2024

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At a glance

  • Drugs Filgotinib (Primary)
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms DARWIN-2
  • Sponsors Galapagos NV

    • 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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