NCT02118584.

Trial name or title	An open label extension and safety monitoring study of moderate to severe ulcerative colitis patients previously enrolled in etrolizumab phase III studies
Methods	SC injection of placebo or etrolizumab 105 mg administered every 4 weeks for up to 7 years
Participants	˜2600 patients Inclusion criteria: Part 1 (open‐label extension): patients are males and females over the age of 18 who were previously enrolled in a phase III study on etrolizumab who met the open‐label criteria outlined in the original study Part 2 (safety monitoring): patients are males and females over the age of 18 who previously enrolled in a phase III study on etrolizumab who were not eligible or chose not to participate in Part 1
Interventions	Part 1: open‐label etrolizumab 105 mg Part 2: no intervention
Outcomes	Primary outcomes: long‐term efficacy as determined by partial Mayo Clinic Score (pMCS), incidence of adverse events
Starting date	September 2014
Contact information	Reference Study ID Number: GA28951 www.roche.com/about_roche/roche_worldwide.htm
Notes	Study is active: patients are being recruited