NCT02163759.

Trial name or title	A phase III, randomized, double‐blind, double‐dummy, placebo‐controlled, multicenter study to evaluate the efficacy (induction of remission) and safety of etrolizumab compared with adalimumab and placebo in patients with moderate to severe ulcerative colitis in patients who are naive to TNF inhibitors (Study #1)
Methods	SC injection of etrolizumab 105 mg and adalimumab placebo administered at weeks 0, 2, 4, 6 and 8, or, SC injection of etrolizumab placebo and adalimumab 160 mg administered at week 0, 89 mg at week 2, and 40 mg at weeks 4, 6 and 8, or, etrolizumab placebo and adalimumab placebo administered at Weeks 0, 2, 4, 6 and 8
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	Group 1: etrolizumab + adalimumab placebo Group 2: etrolizumab placebo + adalimumab Group 3: etrolizumab placebo + adalimumab placebo
Outcomes	Primary outcome: induction of remission compared with placebo (determined by MCS) Secondary outcome: induction of remission compared with adalimumab (determined by MCS)
Starting date	November 2014
Contact information	Contact: Reference Study ID Number: GA28948 www.roche.com/about_roche/roche_worldwide.htm
Notes	Study is active: patients are being recruited