NCT01461317.

Trial name or title	A phase II open‐label extension study to evaluate the long‐term safety of rhuMAb beta7 in patients with moderate to severe ulcerative colitis
Methods	Patients will receive a repeating SC injection of etrolizumab; safety and efficacy will be assessed through 104 weeks
Participants	˜ 116 patients Inclusion Criteria: Males and females between 18 to 75 years old with active ulcerative colitis Patients had failed to obtain a clinical response by week 10, or they obtained a clinical response by week 10 but they had a flare‐up between weeks 10 and 28 in a previous phase II study (ABS4986g) Patients in the Unitied States must discontinue concomitant immunosuppressive therapy before enrolment and completely taper off oral corticosteroids 24 weeks before study entry
Interventions	Group 1: SC injection of etrolizumab 150 mg/ml
Outcomes	Primary outcomes: adverse events, serious adverse events Secondary outcomes: clinically significant changes in vital signs and safety laboratory measures, discontinuation due to adverse events, incidence and nature of injection‐site reactions/hypersensitivity, incidence of infections complications, immunogenicity (incidence of anti‐therapeutic antibodies)
Starting date	November 2011
Contact information	Genentech, Inc.
Notes	Study is active; enrolment is complete