NCT02136069.

Trial name or title	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
Methods	SC injection of etrolizumab 105 mg administered every 4 weeks plus placebo IV infusions at weeks 0, 2 and 6, and then every 8 weeks, or, IV infusion of infliximab 5 mg/kg at weeks 0, 2 and 6, and then every 8 weeks plus SC placebo every 4 weeks
Participants	˜720 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 Patients had an inadequate response/intolerance to prior corticosteroid and/or immunosuppressant treatment
Interventions	Group 1 (experimental): etrolizumab + placebo Group 2 (active comparator): infliximab + placebo
Outcomes	Primary outcomes: proportion of patients in clinical remission (determined by MCS) Secondary outcomes: proportion of patients with clinical response (determined by MCS) at week 10, proportion of patients with sustained clinical response at weeks 10, 30 and 54
Starting date	December 2014
Contact information	Reference Study ID Number: GA29103 www.roche.com/about_roche/roche_worldwide.htm
Notes	Study is active: patients are being recruited