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) |
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.
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 =8
weeks prior to screening or oral antibiotics =4 weeks prior to screening. Treatment
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
130
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Kinston Medical Specialists offers comprehensive medical services for all ages. Whether it’s a case of...
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1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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University of South Florida The University of South Florida is a high-impact, global research university...
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1500 E Medical Center Dr
Ann Arbor, Michigan 48109
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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191 Biltmore Avenue
Asheville, North Carolina 28801
Asheville, North Carolina 28801
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Emory University Hospital As the largest health care system in Georgia and the only health...
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171 Ashley Avenue
Charleston, South Carolina 29425
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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1215 Lee Street
Charlottesville, Virginia 22908
Charlottesville, Virginia 22908
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303 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 503-8194
Northwestern University Feinberg School of Medicine Northwestern University Feinberg School of Medicine, founded in 1859,...
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University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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2093 Health Drive Southwest
Grand Rapids, Michigan 49506
Grand Rapids, Michigan 49506
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2500 North State Street
Jackson, Mississippi 39216
Jackson, Mississippi 39216
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7000 West Colfax Avenue
Lakewood, Colorado 80215
Lakewood, Colorado 80215
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University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
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Quality Clinical Research, Inc. Welcome to Quality Clinical Research. We originated here in Omaha, NE...
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101 The City Drive South
Orange, California 92868
Orange, California 92868
714-456-7890
University of California, Irvine Medical Center We are UC Irvine Health. We are a devoted...
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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