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
131
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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701 Doctors Dr
Kinston, North Carolina 28504
(252) 559-2200
Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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740 South Limestone Street
Lexington, Kentucky 40536
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610 3rd St # 206
Macon, Georgia 31201
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260 Lookout Pl # 201
Maitland, Florida 32751
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Orlando, Florida 32806
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819 E 1st St # 6
Sanford, Florida 32771
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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701 West Morse Boulevard
Winter Park, Florida 32789
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
(734) 936-4000
University of Michigan Health System The University of Michigan is home to one of the...
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Arcadia, California 91006
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191 Biltmore Avenue
Asheville, North Carolina 28801
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
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Atlanta, Georgia 30342
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Baton Rouge, Louisiana 70809
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Belton, Missouri 64012
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Camarillo, California 93012
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlotte, North Carolina 28207
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1215 Lee Street
Charlottesville, Virginia 22908
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30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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Cincinnati, Ohio 45206
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3001 Executive Drive
Clearwater, Florida 33762
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Clinton, Utah 84015
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Colorado Springs, Colorado 80907
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Columbus, Georgia 31904
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3001 Coral Hills Drive
Coral Springs, Florida 33065
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3409 Worth Street
Dallas, Texas 75231
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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1378 Northwest 124th Street
Des Moines, Iowa 50312
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10200 Northwest 25th Street
Doral, Florida 33172
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301 East Muhammad Ali Boulevard
Elizabethtown, Kentucky 42791
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Fayetteville, North Carolina 28304
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3450 Hull Road
Gainesville, Florida 32610
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Garden Grove, California 92843
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Germantown, Tennessee 38138
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Glendora, California 91741
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2093 Health Drive Southwest
Grand Rapids, Michigan 49506
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Great Neck, New York 11021
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7021 Augusta Road
Greenville, South Carolina 29604
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Hollywood, Florida 33021
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Idaho Falls, Idaho 83404
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Kinston, North Carolina 28501
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Laguna Hills, California 92653
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7000 West Colfax Avenue
Lakewood, Colorado 80215
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Long Beach, California 90822
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Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Marietta, Georgia 30060
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Marlborough, Massachusetts 01752
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4730 West Bancroft Street
Maumee, Ohio 43537
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1611 Northwest 12th Avenue
Miami, Florida 33130
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2630 Grant Line Road
New Albany, Indiana 47150
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3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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101 The City Drive South
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Orange City, Florida 32763
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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