Study for Participants With Ulcerative Colitis Previously Enrolled in Etrolizumab Phase II/III Studies



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/16/2019
Start Date:September 15, 2014
End Date:April 8, 2025
Contact:Reference Study ID Number: GA28951 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 Moderate to Severe Ulcerative Colitis Patients Previously Enrolled in Etrolizumab Phase II/III Studies

This two-part, part 1: open-label extension (OLE) and part 2: safety monitoring (SM) study
will examine the efficacy and safety of continued etrolizumab treatment in moderate to severe
ulcerative colitis (UC) participants previously enrolled in etrolizumab Phase II/III studies.
Participants with moderate to severe UC who were enrolled in the Phase II OLE study (GA27927
[NCT01461317]) or the Phase III studies (GA28948 [NCT02163759], GA28949 [NCT02171429],
GA28950 [NCT02100696], GA29102 [NCT02165215], and GA29103 [NCT02136069]) were included.
Participants from the Phase II OLE study or the Phase III studies who are not eligible or
willing to receive etrolizumab in the OLE-SM study, and who have completed the 12-week safety
follow-up period will be enrolled in Part 2. Part 1 of OLE-SM will continue for up to 7 years
after the first participant is enrolled into the study. Following Part 1, participants will
enter Part 2 for a period of 92 weeks.


Inclusion Criteria:

Part 1 (Open-label Extension)

- Participants previously enrolled in the Phase II OLE study or Phase III controlled
studies who meet the eligibility criteria for open-label etrolizumab for those studies as
described in the protocol

Part 2 (Safety Monitoring)

- Participants whose safety follow-up or PML follow-up is not completed within Study
GA27927 and participants who had their last dose of etrolizumab in July 2016 in Study
GA27927 and are not eligible or willing to enroll in Part 1 (OLE)

- Participants who participated in one of the etrolizumab Phase III studies and are not
eligible or willing to enter Part 1 (OLE)

- Participants who transfer from Part 1 (OLE)

- Completion of the 12-week safety follow-up prior to entering.

Exclusion Criteria:

Part 1 (Open-label Extension)

- Withdrawal of consent from and participant not compliant in the Phase II OLE study or
any of the Phase III studies

- Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 10 or did
not perform the Week 10 visit of the Phase III Studies GA28948, GA28949, GA29102, and
GA29103

- Participant who discontinued etrolizumab/etrolizumab placebo prior to Week 14 or did
not perform the Week 14 visit of the Phase III Study GA28950

- Any new, significant, uncontrolled condition
We found this trial at
162
sites
Shreveport, Louisiana 71103
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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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3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
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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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610 3rd St # 206
Macon, Georgia 31201
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750 Highland Avenue
Madison, Wisconsin 53792
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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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1690 Dunlawton Ave # 220
Port Orange, Florida 32127
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819 E 1st St # 6
Sanford, Florida 32771
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701 West Morse Boulevard
Winter Park, Florida 32789
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Arlington, Texas 76012
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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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Bellevue, Washington 98004
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Belton, Missouri 64012
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Bethlehem, Pennsylvania 18015
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Birmingham, Alabama 35233
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Brockton, Massachusetts 02302
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Brownsburg, Indiana
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2000 Regency Parkway
Cary, North Carolina 27511
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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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Chattanooga, Tennessee 37421
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30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
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Chevy Chase, Maryland 20815
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303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
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5841 South Maryland Avenue
Chicago, Illinois 60637
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10123 Alliance Road
Cincinnati, Ohio 45014
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2925 Vernon Place
Cincinnati, Ohio 45219
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750 Pi y Margall
Ciudad Autonoma Buenos Aires, C1155
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3001 Executive Drive
Clearwater, Florida 33762
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Clinton, Utah 84015
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Colorado Springs, Colorado 80907
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Columbia, South Carolina 29203
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Coral Springs, Florida 33071
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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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Decatur, Alabama 35601
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1378 Northwest 124th Street
Des Moines, Iowa 50312
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Detroit, Michigan 48202
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Dothan, Alabama 36305
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2400 Pratt Street
Durham, North Carolina 27705
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3205 Fire Road
Egg Harbor Township, New Jersey 08234
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Evansville, Indiana 47714
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Fort Worth, Texas 76104
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1575 North Rivercenter Drive
Glendale, Wisconsin 53212
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Great Neck, New York 11021
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Hollywood, Florida 33021
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Homestead, Florida 33030
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7200 Cambridge Street
Houston, Texas 77030
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Houston, Texas 77098
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425 Volker Boulevard
Kansas City, Missouri 64131
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Kinston, North Carolina 28504
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LaFayette, Colorado 80026
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Laguna Hills, California 92653
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Las Vegas, Nevada 89113
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Limerick, Pennsylvania 19468
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Little Rock, Arkansas 72211
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Little Rock, Arkansas 72212
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Long Beach, California 90822
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2080 Century Park East
Los Angeles, California 90067
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757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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700 South Park Street
Madison, Wisconsin 53715
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Marietta, Georgia 30060
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Miami, Florida 33122
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Miami, Florida 33155
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Miami Beach, Florida 33140
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8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
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Minneapolis, Minnesota 55455
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Miramar, Florida 33025
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Modesto, California 95355
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Naples, Florida 34102
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Nashville, Tennessee 37211
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2630 Grant Line Road
New Albany, Indiana 47150
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