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Therapeutic Areas: Gastroenterology | Family Medicine
Disease Category: Crohn's Disease
Location: United States, FL

Clinical Trial Details


Research Study Summary

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 III, double-blind, placebo-controlled study evaluating the safety and efficacy of etrolizumab during induction and maintenance treatment of moderate to severely active Crohn's disease (CD) in patients who are anti-tumor necrosis factor (TNF) naive (TNF-naive) and in patients who are refractory or intolerant of tumor necrosis factor inhibitors.

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CW ID: 226285
Date Last Changed: August 31, 2017

Clinical Trial Snapshot

Both Male and Female
18 to 80 Years
Overall Status
Lead Sponsor
Hoffmann-La Roche
Facility Type


Inclusion Criteria:
  • 18-80 years of age (inclusive)
  • Moderately to severely active Crohn's disease as determined by the Crohn's Disease Activity Index (CDAI), patient reported outcomes and endoscopically defined disease activity in the ileum and/or colon
  • Intolerance, loss of response or failure to respond to corticosteroids (CS) or, immunosuppressants (IS), or TNF inhibitors within the previous 5 years
  • 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, indeterminant 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 efilizumab, as stated in the protocol)
  • Chronic hepatitis B or C infection, HIV, active or latent tuberculosis (patients with prior history of BCG vaccination must pass protocol-defined screening criteria)

More Info



Rachel Karlnoski
University of South Florida - Tampa General Hospital
1 Tampa General Circle
Tampa, FL 33606
Phone: (813) 844-4133

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