A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors (Study #1)



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/13/2019
Start Date:November 4, 2014
End Date:December 29, 2020
Contact:Reference Study ID Number: GA28948 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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Phase III, Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy (Induction of Remission) and Safety of Etrolizumab Compared With Adalimumab and Placebo in Patients With Moderate to Severe Ulcerative Colitis Who Are Naive to TNF Inhibitors

This Phase III, double blind, placebo and active comparator controlled, multicenter study
will investigate the efficacy and safety of etrolizumab in induction of remission in
participants with moderately to severely active UC who are naIve to TNF inhibitors and
refractory to or intolerant of prior immunosuppressant and/or corticosteroid treatment.


Inclusion Criteria:

- Diagnosis of UC established at least 3 months prior to randomization (Day 1)

- Moderately to severely active UC as determined by the MCS

- Naive to treatment with TNF inhibitor therapy

- An inadequate response, loss of response, or intolerance to prior corticosteroid
and/or immunosuppressant treatment

- Background UC therapy may include oral 5-aminosalisylate (ASA), oral corticosteroids,
budesonide, probiotics, azathioprine (AZA), 6-mercaptopurine (MP), or methotrexate
(MTX) if doses have been stable for the 8 weeks immediately prior to randomization

- Use of highly effective contraception method as defined by the protocol

- Have received a colonoscopy within the past year or be willing to undergo a
colonoscopy in lieu of a flexible sigmoidoscopy at screening

Exclusion Criteria:

- A history of or current conditions and diseases affecting the digestive tract, such as
indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis,
Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, stricture
(stenosis) of the colon, toxic megacolon, or unremoved adenomatous colonic polyps

- Prior or planned surgery for UC

- Past or present ileostomy or colostomy

- Have received non-permitted inflammatory bowel disease (IBD) anti-integrin therapies
(including natalizumab, vedolizumab, and efalizumab) as stated in the protocol

- Any prior treatment with anti-adhesion molecules (e.g., anti-mucosal addressin cell
adhesion molecule-1 [anti-MAdCAM-1])

- Congenital or acquired immune deficiency, chronic hepatitis B or C infection, HIV
positive

- Evidence of or treatment for Clostridium difficile within 60 days prior to
randomization or other intestinal pathogens within 30 days prior to randomization

- History of active or latent tuberculosis (TB), recurrent opportunistic infections,
severe disseminated viral infections and organ transplant

- Any major episode of infection requiring treatment with intravenous (IV) antibiotics
within 8 weeks prior to screening or oral antibiotics within 4 weeks prior to
screening

- Received a live attenuated vaccine within 4 weeks prior to randomization
We found this trial at
33
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2728
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Miami, FL
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610 3rd St # 206
Macon, Georgia 31201
2252
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Macon, GA
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260 Lookout Pl # 201
Maitland, Florida 32751
2543
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Maitland, FL
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819 E 1st St # 6
Sanford, Florida 32771
2539
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Sanford, FL
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8200 Matlock Road
Arlington, Texas 76002
1675
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Arlington, TX
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Baton Rouge, Louisiana 70809
2035
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Baton Rouge, LA
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2485
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Boston, MA
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Charlotte, North Carolina 28207
2283
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Charlotte, NC
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Chattanooga, Tennessee 37421
2090
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Chattanooga, TN
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
1737
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Chicago, IL
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Cincinnati, Ohio 45267
1967
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Cincinnati, OH
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750 Pi y Margall
Ciudad Autonoma Buenos Aires, C1155
6920
mi
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Ciudad Autonoma Buenos Aires,
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2400 Pratt Street
Durham, North Carolina 27705
2339
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Durham, NC
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984
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Garden Grove, CA
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Hollywood, Florida 33021
2719
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Hollywood, FL
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7000 West Colfax Avenue
Lakewood, Colorado 80215
1017
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Lakewood, CO
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2513
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Largo, FL
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Little Rock, Arkansas 72211
1782
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Little Rock, AR
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
1938
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Louisville, KY
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999
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Mission Viejo, CA
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Naples, Florida 34102
2643
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Naples, FL
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Ogden, Utah 84405
678
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Ogden, UT
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1200 Children's Avenue
Oklahoma City, Oklahoma 73104
1523
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Oklahoma City, OK
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Orlando, Florida 32803
2547
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Orlando, FL
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146
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Portland, OR
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2801 Capitol Avenue
Roseville, California 95661
627
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Roseville, CA
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2714 West Avenue
San Antonio, Texas 78232
1782
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San Antonio, TX
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San Diego, California 92115
1065
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San Diego, CA
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Troy, Michigan 48098
1920
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Troy, MI
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1763
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Tyler, TX
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Urbana, Illinois 61801
1761
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Urbana, IL
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Vineland, New Jersey 08360
2395
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Vineland, NJ
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Ypsilanti, Michigan 48197
1909
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Ypsilanti, MI
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