This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies. Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927 \[NCT01461317\]) or the Phase III studies (GA28948 \[NCT02163759\], GA28949 \[NCT02171429\], GA28950 \[NCT02100696\], GA29102 \[NCT02165215\], and GA29103 \[NCT02136069\]) were included. Participants from the Phase II OLE study or the Phase III studies who are not eligible or willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 9 years after the first participant is enrolled into the study. Following Part 1, participants will enter Part 2 for a period of 92 weeks.
Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study.
Córdoba, Argentina
Rosario, Argentina