Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
Public ClinicalTrials.gov record NCT02403323. 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 Patients With Moderately to Severely Active Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Protocol GA29144
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 \[NCT02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.
Study identification
- NCT ID
- NCT02403323
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 790 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
- Jun 8, 2015 (Actual)
- Primary completion
- Oct 9, 2023 (Actual)
- Completion
- Oct 9, 2023 (Actual)
- Last update posted
- Dec 2, 2024
2015 – 2023
United States locations
- U.S. sites
- 59
- U.S. states
- 24
- U.S. cities
- 54
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Valley Gastroenterology Consultants | Arcadia | California | 91006 | — |
| University of California San Diego Medical Center | La Jolla | California | 92093-5354 | — |
| VA Long Beach Healthcare System | Long Beach | California | 90822 | — |
| Digestive Care Associates, A Medical Corporation | San Carlos | California | 94070 | — |
| SDG Clinical Research | San Diego | California | 92103 | — |
| Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri | San Francisco | California | 94158 | — |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | — |
| Innovative Medical Research of South Florida | Aventura | Florida | 33180 | — |
| West Central Gastroenterology d/b/a Gastro Florida | Clearwater | Florida | 33756 | — |
| University of Florida College of Medicine | Gainesville | Florida | 32610 | — |
| Borland-Groover Clinic | Jacksonville | Florida | 32256 | — |
| IMIC, Inc | Miami Beach | Florida | 33140 | — |
| FQL Research, LLC | Miramar | Florida | 33025 | — |
| Shafran Gastroenterology Center | Winter Park | Florida | 32789 | — |
| Emory University Hospital | Atlanta | Georgia | 30322 | — |
| Atlanta Gastroenterology Associates | Atlanta | Georgia | 30342 | — |
| Columbus Regional Research Institute | Columbus | Georgia | 31904 | — |
| Atlanta Center for Gastroenterology, PC | Decatur | Georgia | 30033 | — |
| Gastroenterology Associates of Central Georgia | Macon | Georgia | 31201 | — |
| Gastrointestinal Specialists of Georgia, PC | Marietta | Georgia | 30060 | — |
| Advanced Clinical Research | Spokane | Idaho | 99202 | — |
| Northwestern Uni-Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| University of Chicago Medical Center | Chicago | Illinois | 60637 | — |
| Southwest Gastroenterology | Oak Lawn | Illinois | 60453 | — |
| Carle Foundation Hospital | Urbana | Illinois | 61801-2500 | — |
| Cotton-O'Neil Clinical Research Center, Digestive Health | Topeka | Kansas | 66606 | — |
| Gastroenterology Associates, LLC | Baton Rouge | Louisiana | 70809 | — |
| Louisiana Research Center, LLC | Shreveport | Louisiana | — | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Gastroenterology Associates of Western Michigan, P.L.C. | Grand Rapids | Michigan | 49506 | — |
| Henry Ford Health System | Novi | Michigan | 48377-3600 | — |
| Center for Digestive Health | Troy | Michigan | 48098 | — |
| Mayo Clinic - Rochester | Rochester | Minnesota | 55905 | — |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | — |
| Ehrhardt Clinical Research, LLC | Belton | Missouri | 64012 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| Weill Cornell Medical College-New York Presbyterian Hospital | New York | New York | 10021 | — |
| Lenox Hill Hospital | New York | New York | 10075 | — |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | — |
| Charlotte Gastroenterology and Hepatology, P.L.L.C | Charlotte | North Carolina | 28207 | — |
| Vidant Medical Group, LLC DBA Vidant Multispeciality Clinic-Kinston | Kinston | North Carolina | 28501 | — |
| Consultants for Clinical Research Inc. | Cincinnati | Ohio | 45219 | — |
| Great Lakes Gastroenterology Research, LLC | Mentor | Ohio | 44060 | — |
| Digestive Disease Specialists, Inc. | Oklahoma City | Oklahoma | 73112 | — |
| Great Lakes Medical Research, LLC | Harrisburg | Pennsylvania | 17110 | — |
| Innovative Clinical Research | Greenville | South Carolina | 29604 | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| University of Texas Southwestern Medical Center; Internal Medicne | Dallas | Texas | 75390-9151 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| Methodist Hospital Research Institute | Houston | Texas | 77030 | — |
| Wellness Clinical Research Center | San Antonio | Texas | 78232 | — |
| Texas Digestive Disease Consultants - Southlake | Southlake | Texas | 76092 | — |
| Digestive Health Specialists of Tyler | 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 | — |
| Digestive Disease Institute; Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
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 228 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02403323, 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 Dec 2, 2024 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02403323 live on ClinicalTrials.gov.