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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Trial Summary
Trial Overview
Inclusion Criteria

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
sites
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
(919) 962-2211
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Baylor College of Medicine
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
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Indiana University
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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University of Mississippi Medical Center
2500 N State St
Jackson, Mississippi 39216
(601) 984-1000
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Borland-Groover Clinic
4800 Belfort Rd # 2
Jacksonville, Florida 32256
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Kinston Medical Specialists
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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University of Kentucky Medical Center
740 South Limestone Street
Lexington, Kentucky 40536
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Gastroenterology Associates of Central Georgia
610 3rd St # 206
Macon, Georgia 31201
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Center for Advanced Gastroenterology
260 Lookout Pl # 201
Maitland, Florida 32751
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Vanderbilt University Medical Center
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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Internal Medicine Specialists
Orlando, Florida 32806
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International Clinical Research
819 E 1st St # 6
Sanford, Florida 32771
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University of South Florida
4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
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Shafran Gastroenterology Center
701 West Morse Boulevard
Winter Park, Florida 32789
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University of Michigan Health System
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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Valley Gastroenterology Consultants
Arcadia, California 91006
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Texas Physicians Medical Research Group
Arlington, Texas 76015
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Asheville Gastroenterology Associates, P.A.; Gastroenterology
191 Biltmore Avenue
Asheville, North Carolina 28801
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Agile Clinical Research Trials,LLC
750 Hammond Drive Northeast
Atlanta, Georgia 30342
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Atlanta, GA
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Emory University Hospital
1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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Atlanta Gastroenterology Associates
Atlanta, Georgia 30342
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Innovative Medical Research of South Florida Inc.
Aventura, Florida 33180
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Gastroenterology Associates
Baton Rouge, Louisiana 70809
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Ehrhardt Clinical Research, LLC
Belton, Missouri 64012
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Massachusetts General Hospital - Crohn's & Colitis Center
Boston, Massachusetts 02114
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Boston, MA
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Commonwealth Clinical Studies
Brockton, Massachusetts 02302
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Investigator's Research Group
Brownsburg, Indiana
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Hospital Italiano
Caba,
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Ventura County Gastroenterology
Camarillo, California 93012
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Medical University of South Carolina
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina 28207
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University of Virginia; Gastroenterology and Hepatology
1215 Lee Street
Charlottesville, Virginia 22908
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Clin. Rsrch Inst. of Michigan
30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
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Chevy Chase Clinical Research
Chevy Chase, Maryland 20815
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University of Chicago Medical Center
5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
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Northwestern Uni-Feinberg School of Medicine
Chicago, Illinois 60611
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Consultants for Clinical Research Inc.
Cincinnati, Ohio 45219
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UC Health Clinical Trials Office
Cincinnati, Ohio 45206
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West Central Gastroenterology d/b/a Gastro Florida
3001 Executive Drive
Clearwater, Florida 33762
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Cleveland Clinic Foundation
2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
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Ericksen Research And Development
Clinton, Utah 84015
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Clinton, UT
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Peak Gastroenterology Associates; Gastroenterology
Colorado Springs, Colorado 80907
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Columbus Regional Research Institute
Columbus, Georgia 31904
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GastroCare; Digestive Care Research
3001 Coral Hills Drive
Coral Springs, Florida 33065
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Texas Digestive Disease Consultants - Dallas
3409 Worth Street
Dallas, Texas 75231
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University of Texas Southwestern Medical Center
1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
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Atlanta Center for Gastroenterology, P.C.
Decatur, Georgia 30033
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Decatur, GA
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Rocky Mountain Gastroenterology Associates
Denver, Colorado 80222
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Iowa Digestive Disease Center
1378 Northwest 124th Street
Des Moines, Iowa 50312
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Des Moines, IA
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Jesscan Medical Research
10200 Northwest 25th Street
Doral, Florida 33172
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Doral, FL
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University of Louisville
301 East Muhammad Ali Boulevard
Elizabethtown, Kentucky 42791
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Elizabethtown, KY
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Cumberland Research Associates
Fayetteville, North Carolina 28304
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University of Florida College of Medicine
3450 Hull Road
Gainesville, Florida 32610
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Valley View Internal Medicine
Garden Grove, California 92843
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Gastro One
Germantown, Tennessee 38138
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Germantown, TN
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Valley Gastroenterology Cnslts
Glendora, California 91741
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Gastroenterology Associates of Western Michigan, P.L.C.
2093 Health Drive Southwest
Grand Rapids, Michigan 49506
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Grand Rapids, MI
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Long Island Clin Rsch Asc, LLP
Great Neck, New York 11021
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Innovative Clinical Research
7021 Augusta Road
Greenville, South Carolina 29604
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Medical Research Center of Connecticut, LLC
Hamden, Connecticut 06518
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Center for Gastrointestinal Disorders
Hollywood, Florida 33021
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The Methodist Hospital Research Institute
Houston, Texas 77030
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Grand Teton Research Group
Idaho Falls, Idaho 83404
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Atlantic Medical Group
Kinston, North Carolina 28501
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University of California, San Diego Medical Center
La Jolla, California 92093
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Therapeutic Research Institute of Orange County
Laguna Hills, California 92653
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Rocky Mountain Gastroenterology Associates, P.L.L.C.; Gastroenterology
7000 West Colfax Avenue
Lakewood, Colorado 80215
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Florida Center for Gastroenterology
Largo, Florida 33777
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Largo, FL
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VA Long Beach Healthcare System
Long Beach, California 90822
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University of Wisconsin
Madison, Wisconsin 53792
(608) 263-2400
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Gastrointestinal Specialists of Georgia
Marietta, Georgia 30060
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Community Clinical Research Network
Marlborough, Massachusetts 01752
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Advanced Medical Research
4730 West Bancroft Street
Maumee, Ohio 43537
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Maumee, OH
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Great Lakes Gastroenterology Research
Mentor, Ohio 44060
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Mentor, OH
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City Medical Group
1611 Northwest 12th Avenue
Miami, Florida 33130
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Advanced Clinical Research of Miami
Miami, Florida 33155
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Regenerate Clinical Trials
Miami, Florida 33155
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IMIC, Inc
Miami Beach, Florida 33140
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FQL Research, LLC
Miramar, Florida 33025
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Miramar, FL
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Gastroenterology Group of Naples
Naples, Florida 34102
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Aquiant Research
2630 Grant Line Road
New Albany, Indiana 47150
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North Shore/Long Island Jewish PRIME; Pediatric Hematology/Oncology & Stem Cell Transplantation
1999 Marcus Avenue
New Hyde Park, New York 11042
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Advanced Research Institute, Inc
New Port Richey, Florida
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Concorde Medical Group
New York, New York 10016
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Weill Cornell Medical College/New York Presbyterian Hospital
New York, New York 10021
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Mount Sinai - PRIME
New York, New York 10029
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Lenox Hill Hospital
New York, New York 10021
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Digestive and Liver Disease Specialists
Norfolk, Virginia 23502
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Central Sooner Research
Norman, Oklahoma 73069
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Clinical Trials of South Carolina
North Charleston, South Carolina 29406
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Med-Care Research
North Miami Beach, Florida 33162
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California Medical Research Associates Inc.
Northridge, California 91324
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Southwest Gastroenterology
Oak Lawn, Illinois 60453
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Advanced Research Institute
Ogden, Utah 84405
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Digestive Disease Specialists
3366 Northwest Expressway
Oklahoma City, Oklahoma 73112
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Quality Clinical Research, Inc.
10040 Regency Cir
Omaha, Nebraska 68114
(402) 934-0044
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University of California, Irvine Medical Center
101 The City Drive South
Orange, California 92868
714-456-7890
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Medical Research Group of Central Florida
Orange City, Florida 32763
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Premier Medical Group of the Hudson Valley
243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
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McGuire Research Institute; Gastroenterology
Richmond, Virginia 23249
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