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Summary

for people ages 18–80 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Crohn Disease

Eligibility

You can join if…

Open to people ages 18–80

  • 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

You CAN'T join if...

  • 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)

Locations

  • Digestive Care Associates, A Medical Corporation accepting new patients
    San Carlos, California, 94070, United States
  • California Medical Research Associates, Inc. accepting new patients
    Northridge, California, 91324, United States
  • Ventura Clinical Trials accepting new patients
    Ventura, California, 90265, United States
  • University of California, Irvine Medical Center withdrawn
    Orange, California, 92868, United States
  • MMJ Medical Inc. accepting new patients
    Corona, California, 92881, United States
  • Therapeutic Research Institute of Orange County accepting new patients
    Laguna Hills, California, 92653, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02394028
Phase
Phase 3
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated
March 1, 2017
I’m interested in this study!