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
Phase of Trial: Phase III
Latest Information Update: 19 Apr 2018
At a glance
- Drugs Etrolizumab (Primary) ; Infliximab
- Indications Ulcerative colitis
- Focus Registrational; Therapeutic Use
- Acronyms GARDENIA
- Sponsors Roche
- 07 Nov 2017 Planned End Date changed from 28 Feb 2019 to 30 Mar 2023.
- 07 Nov 2017 Planned primary completion date changed from 28 Feb 2019 to 30 Mar 2023.
- 01 Sep 2016 Planned End Date changed from 1 Sep 2019 to 1 Feb 2019.