NCT02100696.

Trial name or title	Phase III, double blind, placebo‐controlled, multicenter study of the efficacy and safety of etrolizumab during induction and maintenance in patients with moderate to severe active ulcerative colitis who are refractory to or intolerant of TNF inhibitors
Methods	Double‐blind, randomized, placebo‐controlled study; SC injection of placebo or etrolizumab 105 mg administered every 4 weeks
Participants	˜800 patients Inclusion Criteria: Males and females between 18 to 80 years of age with moderate to severe active UC (determined by MCS score) who have experienced intolerance, loss of response or failure to respond to treatment with at least one TNF‐inhibitor in the past 5 years
Interventions	Group 1: Blinded (Cohort 2): etrolizumab induction (I) + maintenance (M) Group 2: Experimental: Blinded (Cohort 2): etrolizumab I + placebo M Group 3: Placebo Comparator: Blinded (Cohort 2): placebo I + M Group 4: Open‐label (Cohort 1): etrolizumab I + M Group 5: Open‐label (Cohort 1): etrolizumab I + placebo M
Outcomes	Primary outcomes: Clinical remission (determined by MCS) at week 14, maintenance of remission at week 66
Starting date	May 2014
Contact information	Reference Study ID Number: GA28950 www.roche.com/about_roche/roche_worldwide.htm
Notes	Study is active; patients are being recruited