Loading clinical trials...
Loading clinical trials...
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
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Valley Gastroenterology Consultants
Arcadia, California, United States
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
Start Date
June 8, 2015
Primary Completion Date
October 9, 2023
Completion Date
October 9, 2023
Last Updated
December 2, 2024
790
ACTUAL participants
Etrolizumab
DRUG
Lead Sponsor
Hoffmann-La Roche
NCT07245394
NCT07089420
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions