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)

Use our guide to learn which trials are right for you!

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
?
mi
from
Tyler, TX
Click here to add this to my saved trials
Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
?
mi
from
Chapel Hill, NC
Click here to add this to my saved trials
3500 Camp Bowie Boulevard
Fort Worth, Texas 76107
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
7000 Fannin St
Houston, Texas 77030
(713) 500-4472
University of Texas Health Science Center at Houston The University of Texas Health Science Center...
?
mi
from
Houston, TX
Click here to add this to my saved trials
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...
?
mi
from
Jackson, MS
Click here to add this to my saved trials
4800 Belfort Rd # 2
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
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...
?
mi
from
Kinston, NC
Click here to add this to my saved trials
610 3rd St # 206
Macon, Georgia 31201
?
mi
from
Macon, GA
Click here to add this to my saved trials
750 Highland Avenue
Madison, Wisconsin 53792
?
mi
from
Madison, WI
Click here to add this to my saved trials
260 Lookout Pl # 201
Maitland, Florida 32751
?
mi
from
Maitland, FL
Click here to add this to my saved trials
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...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
1690 Dunlawton Ave # 220
Port Orange, Florida 32127
?
mi
from
Port Orange, FL
Click here to add this to my saved trials
819 E 1st St # 6
Sanford, Florida 32771
?
mi
from
Sanford, FL
Click here to add this to my saved trials
701 West Morse Boulevard
Winter Park, Florida 32789
?
mi
from
Winter Park, FL
Click here to add this to my saved trials
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...
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
Arlington, Texas 76012
?
mi
from
Arlington, TX
Click here to add this to my saved trials
?
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina 28801
?
mi
from
Asheville, NC
Click here to add this to my saved trials
750 Hammond Drive Northeast
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30342
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Aventura, FL
Click here to add this to my saved trials
Baton Rouge, Louisiana 70809
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
Bellevue, Washington 98004
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Belton, Missouri 64012
?
mi
from
Belton, MO
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Birmingham, Alabama 35233
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Boston, MA
Click here to add this to my saved trials
Brockton, Massachusetts 02302
?
mi
from
Brockton, MA
Click here to add this to my saved trials
Brownsburg, Indiana
?
mi
from
Brownsburg, IN
Click here to add this to my saved trials
2000 Regency Parkway
Cary, North Carolina 27511
?
mi
from
Cary, NC
Click here to add this to my saved trials
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...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1215 Lee Street
Charlottesville, Virginia 22908
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Chattanooga, Tennessee 37421
?
mi
from
Chattanooga, TN
Click here to add this to my saved trials
30795 23 Mile Rd # 206
Chesterfield, Michigan 48047
?
mi
from
Chesterfield, MI
Click here to add this to my saved trials
Chevy Chase, Maryland 20815
?
mi
from
Chevy Chase, MD
Click here to add this to my saved trials
303 E Chicago Ave
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
5841 South Maryland Avenue
Chicago, Illinois 60637
?
mi
from
Chicago, IL
Click here to add this to my saved trials
10123 Alliance Road
Cincinnati, Ohio 45014
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
2925 Vernon Place
Cincinnati, Ohio 45219
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
750 Pi y Margall
Ciudad Autonoma Buenos Aires, C1155
?
mi
from
Ciudad Autonoma Buenos Aires,
Click here to add this to my saved trials
3001 Executive Drive
Clearwater, Florida 33762
?
mi
from
Clearwater, FL
Click here to add this to my saved trials
Clinton, Utah 84015
?
mi
from
Clinton, UT
Click here to add this to my saved trials
Colorado Springs, Colorado 80907
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
Columbia, South Carolina 29203
?
mi
from
Columbia, SC
Click here to add this to my saved trials
Coral Springs, Florida 33071
?
mi
from
Coral Springs, FL
Click here to add this to my saved trials
3409 Worth Street
Dallas, Texas 75231
?
mi
from
Dallas, TX
Click here to add this to my saved trials
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...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Decatur, Alabama 35601
?
mi
from
Decatur, AL
Click here to add this to my saved trials
?
mi
from
Decatur, GA
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
1378 Northwest 124th Street
Des Moines, Iowa 50312
?
mi
from
Des Moines, IA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Dothan, Alabama 36305
?
mi
from
Dothan, AL
Click here to add this to my saved trials
2400 Pratt Street
Durham, North Carolina 27705
?
mi
from
Durham, NC
Click here to add this to my saved trials
3205 Fire Road
Egg Harbor Township, New Jersey 08234
?
mi
from
Egg Harbor Township, NJ
Click here to add this to my saved trials
Evansville, Indiana 47714
?
mi
from
Evansville, IN
Click here to add this to my saved trials
Fort Worth, Texas 76104
?
mi
from
Fort Worth, TX
Click here to add this to my saved trials
?
mi
from
Garden Grove, CA
Click here to add this to my saved trials
1575 North Rivercenter Drive
Glendale, Wisconsin 53212
?
mi
from
Glendale, WI
Click here to add this to my saved trials
Great Neck, New York 11021
?
mi
from
Great Neck, NY
Click here to add this to my saved trials
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Hollywood, Florida 33021
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Homestead, Florida 33030
?
mi
from
Homestead, FL
Click here to add this to my saved trials
7200 Cambridge Street
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
Houston, Texas 77098
?
mi
from
Houston, TX
Click here to add this to my saved trials
425 Volker Boulevard
Kansas City, Missouri 64131
?
mi
from
Kansas City, MO
Click here to add this to my saved trials
Kinston, North Carolina 28504
?
mi
from
Kinston, NC
Click here to add this to my saved trials
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
LaFayette, Colorado 80026
?
mi
from
LaFayette, CO
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
?
mi
from
Largo, FL
Click here to add this to my saved trials
Las Vegas, Nevada 89113
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Limerick, Pennsylvania 19468
?
mi
from
Limerick, PA
Click here to add this to my saved trials
Little Rock, Arkansas 72211
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Little Rock, Arkansas 72212
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90822
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
2080 Century Park East
Los Angeles, California 90067
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
757 Westwood Plaza
Los Angeles, California 90024
(310) 825-9111
UCLA Medical Center Founded in 1955, UCLA Medical Center became Ronald Reagan UCLA Medical Center...
?
mi
from
Los Angeles, CA
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
700 South Park Street
Madison, Wisconsin 53715
?
mi
from
Madison, WI
Click here to add this to my saved trials
Marietta, Georgia 30060
?
mi
from
Marietta, GA
Click here to add this to my saved trials
?
mi
from
Memphis, TN
Click here to add this to my saved trials
?
mi
from
Mentor, OH
Click here to add this to my saved trials
Miami, Florida 33122
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Miami Beach, Florida 33140
?
mi
from
Miami Beach, FL
Click here to add this to my saved trials
8701 W Watertown Plank Rd
Milwaukee, Wisconsin
(414) 955-8296
Medical College of Wisconsin The Medical College (MCW) of Wisconsin is a major national research...
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
Minneapolis, Minnesota 55455
?
mi
from
Minneapolis, MN
Click here to add this to my saved trials
Miramar, Florida 33025
?
mi
from
Miramar, FL
Click here to add this to my saved trials
Mission Hills, California
?
mi
from
Mission Hills, CA
Click here to add this to my saved trials
?
mi
from
Mission Viejo, CA
Click here to add this to my saved trials
Modesto, California 95355
?
mi
from
Modesto, CA
Click here to add this to my saved trials
Naples, Florida 34102
?
mi
from
Naples, FL
Click here to add this to my saved trials
Nashville, Tennessee 37211
?
mi
from
Nashville, TN
Click here to add this to my saved trials
2630 Grant Line Road
New Albany, Indiana 47150
?
mi
from
New Albany, IN
Click here to add this to my saved trials