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 #2)



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/13/2019
Start Date:November 14, 2014
End Date:December 29, 2020
Contact:Reference Study ID Number: GA28949 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
34
sites
Houston, Texas 77098
570
mi
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Houston, TX
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300 Community Drive
Manhasset, New York 11030
(516) 562-0100
North Shore University Hospital North Shore-LIJ Health System includes 16 award-winning hospitals and nearly 400...
1302
mi
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Manhasset, NY
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Orlando, Florida 32806
1143
mi
from
Orlando, FL
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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...
808
mi
from
Ann Arbor, MI
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1444
mi
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Boston, MA
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321 South Columbia Street
Chapel Hill, North Carolina 27599
1044
mi
from
Chapel Hill, NC
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2019 Avenida Córdoba
Ciudad Autonoma de Buenos Aires, 1120
5601
mi
from
Ciudad Autonoma de Buenos Aires,
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805
mi
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Decatur, GA
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409
mi
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Denver, CO
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3205 Fire Road
Egg Harbor Township, New Jersey 08234
1257
mi
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Egg Harbor Township, NJ
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Germantown, Tennessee 38138
481
mi
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Germantown, TN
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Hagerstown, Maryland 21740
1088
mi
from
Hagerstown, MD
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1345
mi
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Hamden, CT
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425 Volker Boulevard
Kansas City, Missouri 64131
196
mi
from
Kansas City, MO
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Kinston, North Carolina 28501
1134
mi
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Kinston, NC
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700 South Park Street
Madison, Wisconsin 53715
574
mi
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Madison, WI
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Marietta, Georgia 30060
788
mi
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Marietta, GA
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915
mi
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Mentor, OH
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Nashville, Tennessee 37211
623
mi
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Nashville, TN
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New Port Richey, Florida
1096
mi
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New Port Richey, FL
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New York, New York 10016
1288
mi
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New York, NY
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New York, New York 10024
1225
mi
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New York, NY
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North Charleston, South Carolina 29406
1054
mi
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North Charleston, SC
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Orange, California 92868
1154
mi
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Orange, CA
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Orlando, Florida 32803
1141
mi
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Orlando, FL
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243 N Rd
Poughkeepsie, New York 12601
(845) 471-9410
Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
1294
mi
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Poughkeepsie, NY
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1106
mi
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Richmond, VA
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1101 East Marshall Street
Richmond, Virginia 23298
1113
mi
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Richmond, VA
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1000 Laurel Street
San Carlos, California 94070
1333
mi
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San Carlos, CA
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San Diego, California 92123
1139
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San Diego, CA
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1410
mi
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Seattle, WA
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Shreveport, Louisiana 71103
429
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Shreveport, LA
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718 Teaneck Road
Teaneck, New Jersey 07666
1286
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Teaneck, NJ
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146
mi
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Topeka, KS
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