Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
a study on Inflammatory Bowel Disease
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedestimated completion
Description
Summary
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.
Official Title
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
Keywords
Ulcerative Colitis Colitis Colitis, Ulcerative Ulcer rhuMAb Beta7 Etrolizumab
Eligibility
You can join if…
Open to people ages 18 years and up
Part 1 (Open-label Extension)
- Participants previously enrolled in the Phase II OLE study or Phase III controlled studies who meet the eligibility criteria for open-label etrolizumab for those studies as described in the protocol
Part 2 (Safety Monitoring)
- Participants whose safety follow-up or PML follow-up is not completed within Study GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study GA27927 and are not eligible or willing to enroll in Part 1 (OLE)
- Participants who participated in one of the etrolizumab Phase III studies and are not eligible or willing to enter Part 1 (OLE)
- Participants who transfer from Part 1 (OLE)
- Completion of the 12-week safety follow-up prior to entering.
You CAN'T join if...
Part 1 (Open-label Extension)
- Withdrawal of consent from and participant not compliant in the Phase II OLE study or any of the Phase III studies
- Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and GA29103
- Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did not perform the Week 14 visit of the Phase III Study GA28950
- Any new, significant, uncontrolled condition
Locations
- University of California San Diego Medical Center
accepting new patients
La Jolla California 92093-5354 United States - Medical Associates Research Group, Inc.
withdrawn
San Diego California 92123 United States - Clinical Applications Laboratories, Inc.
accepting new patients
San Diego California 92103 United States - San Diego Gastroenterology Medical Associates
not yet accepting patients
San Diego California 92103 United States - Sharp Rees-Stealy Medical Group
withdrawn
San Diego California 92101 United States
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Hoffmann-La Roche
- ID
- NCT02118584
- Phase
- Phase 3
- Study Type
- Interventional
- Last Updated
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