Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Status: | Recruiting |
---|---|
Conditions: | Colitis, Colitis, Gastrointestinal |
Therapuetic Areas: | Gastroenterology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/16/2019 |
Start Date: | September 15, 2014 |
End Date: | April 8, 2025 |
Contact: | Reference Study ID Number: GA28951 www.roche.com/about_roche/roche_worldwide.htm |
Email: | global-roche-genentech-trials@gene.com |
Phone: | 888-662-6728 (U.S. and Canada) |
An Open-Label Extension and Safety Monitoring Study of Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies
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 7 years
after the first participant is enrolled into the study. Following Part 1, participants will
enter Part 2 for a period of 92 weeks.
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 7 years
after the first participant is enrolled into the study. Following Part 1, participants will
enter Part 2 for a period of 92 weeks.
Inclusion Criteria:
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.
Exclusion Criteria:
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
We found this trial at
162
sites
7000 Fannin St
Houston, Texas 77030
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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750 Highland Avenue
Madison, Wisconsin 53792
Madison, Wisconsin 53792
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of Michigan The University of Michigan was founded in 1817 as one of the...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1215 Lee Street
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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5841 South Maryland Avenue
Chicago, Illinois 60637
Chicago, Illinois 60637
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
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University of Louisville The University of Louisville is a state supported research university located in...
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700 South Park Street
Madison, Wisconsin 53715
Madison, Wisconsin 53715
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Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
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