Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies
Public ClinicalTrials.gov record NCT02118584. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02118584
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,822 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Sep 15, 2014 (Actual)
- Primary completion
- Oct 5, 2023 (Actual)
- Completion
- Oct 5, 2023 (Actual)
- Last update posted
- Oct 23, 2024
2014 – 2023
United States locations
- U.S. sites
- 57
- U.S. states
- 22
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama Medical Center | Birmingham | Alabama | 35294 | — |
| University of California San Diego Medical Center | La Jolla | California | 92093-5354 | — |
| University of California, Irvine Medical Center | Orange | California | 92868 | — |
| SDG Clinical Research | San Diego | California | 92103 | — |
| University of California at San Francisco | San Francisco | California | 94115 | — |
| Ventura Clinical Trials | Ventura | California | 93003 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Clinical Research of the Rockies | Lafayette | Colorado | 80026 | — |
| Rocky Mountain Gastroenterology Associates | Wheat Ridge | Colorado | 80033 | — |
| Innovative Medical Research of South Florida, Inc. | Aventura | Florida | 33180 | — |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33756 | — |
| Regenerate Clinical Trials | Miami | Florida | 33155 | — |
| IMIC, Inc | Miami Beach | Florida | 33140 | — |
| FQL Research, LLC | Miramar | Florida | 33025 | — |
| Gastroenterology Group of Naples | Naples | Florida | 34102 | — |
| Advanced Research Institute, Inc. | New Port Richey | Florida | 34653 | — |
| Internal Medicine Specialists | Orlando | Florida | 32806 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Atlanta Gastroenterology Specialists, PC | Suwanee | Georgia | 30024 | — |
| Northwestern University Feinberg School Of Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center; Medicine, Section of Pulmonary | Chicago | Illinois | 60637 | — |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | — |
| Aquiant Research | New Albany | Indiana | 47150 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | — | — |
| Massachusetts General Hospital; Crohn's & Colitis Center | Boston | Massachusetts | 02114 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| Huron Gastroenterology Associates | Ypsilanti | Michigan | 48197 | — |
| Regents of the University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| Kansas City Research Institute, LLC | Kansas City | Missouri | 64131 | — |
| Clinica Peruano Americana S.A. | Great Neck | New York | 11021 | — |
| NYU Langone Medical Center | New York | New York | 10016-9451 | — |
| Weill Cornell Medical College (WCMC) - Judith Jaffe Multiple Sclerosis Center (JJMSC) | New York | New York | 10021 | — |
| Asheville Gastroenterology Associates, P.A. | Asheville | North Carolina | 28801 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Kinston Medical Specialists | Kinston | North Carolina | 28501 | — |
| Consultants for Clin. Rsrch | Cincinnati | Ohio | 45219 | — |
| UC Health Clinical Trials Office; Division of Digestive Diseases | Cincinnati | Ohio | 45267 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Gastroenterology Center of the Midsouth, P.C. | Memphis | Tennessee | 38120 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | — |
| Texas Digestive Disease Consultants - Dallas | Dallas | Texas | 75231 | — |
| Wellness Clinical Research Center | San Antonio | Texas | 78232 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Tyler Research Institute, LLC | Tyler | Texas | 75701 | — |
| Ericksen Research and Development | Clinton | Utah | 84015 | — |
| University of Utah School of Medicine | Salt Lake City | Utah | 84132 | — |
| McGuire Research Institute; Gastroenterology | Richmond | Virginia | 23249 | — |
| Washington Gastroenterology | Bellevue | Washington | 98004 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 354 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02118584, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 23, 2024 · Synced Nov 1, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02118584 live on ClinicalTrials.gov.