NCT02171429.

Trial name or title	Phase III, randomized, double‐blind, double‐dummy, placebo‐controlled, multicenter study to evaluate the efficacy (induction and 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 #2)
Methods	Patients were randomized to one of three treatment groups: experimental (etrolizumab and adalimumab placebo), active comparator (etrolizumab placebo and adalimumab) or placebo comparator (etrolizumab placebo and adalimumab placebo) for 8 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	Goup 1 (experimental): SC etrolizumab 105 mg every 4 weeks, plus SC adalimumab placebo at weeks 0, 2, 4, 6 and 8 Group 2 (active comparator): SC adalimumab 160 mg administered SC at Week 0; 80 mg administered SC at Week 2; 40 mg SC at Weeks 4, 6 and 8, plus SC etrolizumab placebo every 4 weeks Group 3: SC adalimumab placebo at weeks 0, 2, 4, 6 and 8, plus SC etrolizumab placebo every 4 weeks
Outcomes	Primary outcome: induction of remission compared with placebo (determined by the MCS) Secondary outcome: Induction of remission compared with adalimumab (determined by MCS)
Starting date	November 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