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A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

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Trial Profile

A 52-week, Phase 3, Multicentre, Randomised, Double Blind, Efficacy and Safety Study Comparing GSK3196165 With Placebo and With Tofacitinib, in Combination With Methotrexate in Participants With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to Methotrexate

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Mar 2024

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At a glance

  • Drugs Otilimab (Primary) ; Folic acid; Methotrexate; Tofacitinib
  • Indications Rheumatoid arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms contRAst-1
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Research & Development; GSK

    • Most Recent Events

    • 30 Nov 2023 This trial has been completed in Spain according to European Clinical Trials Database record.
    • 12 Sep 2023 Results reporting efficacy and safety of otilimab from two clinical trials (NCT03980483, NCT03970837) published in the Annals of the Rheumatic Diseases
    • 27 Oct 2022 According to a GlaxoSmithKline media release, though the ContRAst-1 and ContRAst-2 trials met their primary endpoints, however the efficacy demonstrated is unlikely to transform patient care for this population. As a result, the company has decided not to progress with regulatory submissions.

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