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
sites
2400 Pratt Street
Durham, North Carolina 27705
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610 3rd St # 206
Macon, Georgia 31201
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Macon, GA
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260 Lookout Pl # 201
Maitland, Florida 32751
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819 E 1st St # 6
Sanford, Florida 32771
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8200 Matlock Road
Arlington, Texas 76002
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Baton Rouge, Louisiana 70809
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Boston, MA
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Charlotte, North Carolina 28207
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Chattanooga, Tennessee 37421
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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...
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Cincinnati, Ohio 45267
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Cincinnati, OH
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750 Pi y Margall
Ciudad Autonoma Buenos Aires, C1155
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Ciudad Autonoma Buenos Aires,
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Garden Grove, CA
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Hollywood, Florida 33021
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Hollywood, FL
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7000 West Colfax Avenue
Lakewood, Colorado 80215
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Largo, FL
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Little Rock, Arkansas 72211
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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...
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Louisville, KY
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Miami, FL
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Mission Viejo, CA
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Naples, Florida 34102
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Ogden, Utah 84405
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1200 Children's Avenue
Oklahoma City, Oklahoma 73104
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Orlando, Florida 32803
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Portland, OR
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2801 Capitol Avenue
Roseville, California 95661
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2714 West Avenue
San Antonio, Texas 78232
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San Diego, California 92115
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Troy, Michigan 48098
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Tyler, TX
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Urbana, Illinois 61801
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Vineland, New Jersey 08360
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Ypsilanti, Michigan 48197
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