Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

Stopped early · Phase 3

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT02403323

Run by

Hoffmann-La Roche

People needed

790

Starts

2015-06-08

Expected to finish

2023-10-09

Last updated by the study team

2024-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Part 1 Open-Label Extension:
• Patients previously enrolled in etrolizumab Phase III study GA29144 (NCT02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol
• Part 2 Safety Monitoring:
• Patients who participated in etrolizumab Phase III study GA29144 (NCT02394028) and are not eligible or choose not to enter Part 1
• Patients who transfer from Part 1
• Completion of the 12-week safety follow-up period prior to entering

You may not qualify if…

• Part 1 Open-Label Extension:
• Any new, significant, uncontrolled condition
• Part 2 Safety Monitoring:
• No exclusion criteria

Where it is running

• University of California San Diego Medical Center — La Jolla, California, United States
• VA Long Beach Healthcare System — Long Beach, California, United States
• Digestive Care Associates, A Medical Corporation — San Carlos, California, United States
• SDG Clinical Research — San Diego, California, United States
• Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri — San Francisco, California, United States
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States
• Innovative Medical Research of South Florida — Aventura, Florida, United States
• West Central Gastroenterology d/b/a Gastro Florida — Clearwater, Florida, United States
• University of Florida College of Medicine — Gainesville, Florida, United States
• Borland-Groover Clinic — Jacksonville, Florida, United States
• IMIC, Inc — Miami Beach, Florida, United States
• FQL Research, LLC — Miramar, Florida, United States
• Shafran Gastroenterology Center — Winter Park, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Columbus Regional Research Institute — Columbus, Georgia, United States
• Atlanta Center for Gastroenterology, PC — Decatur, Georgia, United States
• Gastroenterology Associates of Central Georgia — Macon, Georgia, United States
• Gastrointestinal Specialists of Georgia, PC — Marietta, Georgia, United States
• Advanced Clinical Research — Spokane, Idaho, United States
• Northwestern Uni-Feinberg School of Medicine — Chicago, Illinois, United States
• University of Chicago Medical Center — Chicago, Illinois, United States
• Southwest Gastroenterology — Oak Lawn, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Valley Gastroenterology Consultants — Arcadia, California, United States

Full record on ClinicalTrials.gov

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