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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

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: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 May 2019

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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

    • 07 May 2019 Planned End Date changed from 30 Sep 2020 to 21 Jul 2020.
    • 07 May 2019 Planned primary completion date changed from 30 Jun 2020 to 28 Apr 2020.
    • 07 May 2019 Status changed from recruiting to active, no longer recruiting.
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