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



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:June 8, 2015
End Date:April 19, 2024
Contact:Reference Study ID Number: GA29145 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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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 two-part, open-label extension and safety monitoring study will examine the safety and
efficacy of continued etrolizumab treatment in patients with moderate to severely active
Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.


Inclusion Criteria:

Part 1 Open-label Extension:

- Patients previously enrolled in etrolizumab Phase III study GA29144 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 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

Exclusion Criteria:

Part 1 Open-label Extension:

- Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

- No exclusion criteria
We found this trial at
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Chapel Hill, North Carolina 27599
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1200 Moursund Street
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2500 N State St
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701 Doctors Dr
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Lexington, Kentucky 40536
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Macon, Georgia 31201
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Sanford, Florida 32771
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1500 E Medical Center Dr
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Atlanta, Georgia 30342
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171 Ashley Avenue
Charleston, South Carolina 29425
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