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

Recruiting
Phase of Trial: Phase III

Latest Information Update: 02 Aug 2017

At a glance

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

    • 01 Sep 2016 Planned End Date changed from 1 Sep 2019 to 1 Feb 2019.
    • 01 Sep 2016 Planned primary completion date changed from 1 Sep 2019 to 1 Feb 2019.
    • 31 Dec 2015 Planned End Date changed from 1 Jan 2019 to 1 Sep 2019, according to ClinicalTrials.gov record.
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