NCT02165215.

Trial name or title	Phase III, randomized, double‐blind, placebo‐controlled, multicenter study to evaluate the efficacy (maintenance of remission) and safety of etrolizumab compared with placebo in patients with moderate to severe active ulcerative colitis who are naive to TNF inhibitors
Methods	During the open‐label phase, patients will be given SC etrolizumab 105 mg every 4 weeks During the maintenance phase, patients will be given SC etrolizumab 105 mg or placebo every 4 weeks
Participants	˜350 patients Inclusion criteria: Males and females between 18 to 80 years of age with moderate to severe UC (determined by MCS) who are naive to anti‐TNF therapy Previous inadequate response to or intolerance of corticosteroids and/or immunosuppressant drugs
Interventions	Phase 1: open‐label SC etrolizumab 105 mg Phase 2: SC etrolizumab 105 mg or placebo
Outcomes	Primary outcome: maintenance of clinical remission among randomized patients in clinical remission at week 10 (determined by MCS) Secondary outcomes: maintenance of clinical remission among randomized patients in clinical remission at week 10 (determined by MCS)
Starting date	August 2014
Contact information	Contact: Reference Study ID Number: GA28949 www.roche.com/about_roche/roche_worldwide.htm
Notes	Study is active: patients are being recruited