A Study to Assess Whether Etrolizumab is a Safe and Effective Treatment for Participants With Moderately to Severely Active Crohn's Disease (CD)



Status:Recruiting
Conditions:Gastrointestinal, Crohns Disease
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:3/15/2019
Start Date:March 20, 2015
End Date:February 19, 2021
Contact:Reference Study ID Number: GA29144 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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A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Etrolizumab as an Induction And Maintenance Treatment For Patients With Moderately to Severely Active Crohn's Disease

This is a multicenter, Phase 3, double-blind, placebo-controlled study evaluating the
efficacy, safety, and tolerability of etrolizumab compared with placebo during induction and
maintenance treatment of moderate to severely active CD in participants who are refractory or
intolerant to corticosteroids (CS), immunosuppressants (IS), or anti-tumor necrosis factors
(anti-TNFs) or have inadequate response to anti-tumor necrosis factor (TNF-IR). Participants
who enroll on the basis of refractory or intolerance to CS and/or IS may have been previously
exposed to anti-TNFs or be naïve to anti-TNFs. The study period will consist of Screening
Phase (up to 35 days) plus (+) 14-week Induction Phase + 52-week Maintenance Phase + 12-week
Safety Follow-up Phase. At Week 14 (end of Induction Phase), participants achieving decrease
of 70 points in Crohn's Disease Activity Index (CDAI) from baseline (CDAI-70 response)
without the use of rescue therapy will continue to the Maintenance Phase.


Inclusion Criteria:

- Moderately to severely active CD as determined by the CDAI, patient reported outcomes
and endoscopically defined disease activity in the ileum and/or colon

- Intolerance, refractory disease, or no response to CS, IS, or anti-TNF therapy within
5 years from screening. Participants who have not previously demonstrated inadequate
response or intolerance to one or more anti-TNF therapies are eligible to participate
in the study provided they are intolerant or refractory to CS or IS therapy

- Use of effective contraception as defined by the protocol

Exclusion Criteria:

- A history of, or current conditions affecting the digestive tract, such as ulcerative
colitis, indeterminate colitis, fistulizing disease, abdominal or perianal abscess,
adenomatous colonic polyps not excised, colonic mucosal dysplasia, and short bowel
syndrome

- Planned surgery for CD

- Ileostomy or colostomy

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

- Any prior treatment with ustekinumab within 14 weeks prior to randomization

- Chronic hepatitis B or C infection, human immunodeficiency virus (HIV), active or
latent tuberculosis (participants with prior history of Bacillus Calmette-Guérin [BCG]
vaccination must pass protocol-defined screening criteria)

- Sinus tract with evidence for infection (e.g., purulent discharge) in the clinical
judgment of the investigator. Fistulas related to CD are not exclusionary

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

- Any major episode of infection requiring treatment with intravenous antibiotics weeks prior to screening or oral antibiotics with antibiotics as adjunctive therapy for CD in the absence of documented infection
is not exclusionary

- Hospitalization (other than for elective reasons) within 4 weeks prior to
randomization
We found this trial at
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Chapel Hill, North Carolina 27599
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9500 Euclid Avenue
Cleveland, Ohio 44106
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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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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740 South Limestone Street
Lexington, Kentucky 40536
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610 3rd St # 206
Macon, Georgia 31201
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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
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Orlando, Florida 32806
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819 E 1st St # 6
Sanford, Florida 32771
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4202 E Fowler Ave
Tampa, Florida 33620
(813) 974-2011
University of South Florida The University of South Florida is a high-impact, global research university...
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701 West Morse Boulevard
Winter Park, Florida 32789
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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...
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Arcadia, California 91006
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191 Biltmore Avenue
Asheville, North Carolina 28801
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750 Hammond Drive Northeast
Atlanta, Georgia 30342
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
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Atlanta, Georgia 30342
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4190 Juan D. Peron
Buenos Aires, C1181
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Charlotte, North Carolina 28207
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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
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Chicago, Illinois 60637
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1801 Inwood Rd
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10040 Regency Cir
Omaha, Nebraska 68114
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