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Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

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Trial Profile

Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Etrolizumab (Primary) ; Infliximab
  • Indications Ulcerative colitis
  • Focus Registrational; Therapeutic Use
  • Acronyms GARDENIA
  • Sponsors Roche

    • Most Recent Events

    • 13 Oct 2020 Primary endpoint (Percentage of Participants with both Clinical Response at Week 10 and Clinical Remission at Week 54) has not been met as per results presented at the 28th United European Gastroenterology Week.
    • 13 Oct 2020 Results presented at the 28th United European Gastroenterology Week
    • 30 Jul 2020 This trial has been completed in Belgium and Hungary, according to European Clinical Trials Database record.

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