Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

a study on Crohn's Disease Inflammatory Bowel Disease

Summary

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

Description

Summary

This two-part, open-label extension and safety monitoring study will examine the safety and efficacy of continued etrolizumab treatment in patients with moderate to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144.

Official Title

AN OPEN-LABEL EXTENSION AND SAFETY MONITORING STUDY OF PATIENTS WITH MODERATELY TO SEVERELY ACTIVE CROHN'S DISEASE PREVIOUSLY ENROLLED IN THE ETROLIZUMAB PHASE III PROTOCOL GA29144

Keywords

Crohn Disease

Eligibility

You can join if…

Open to people ages 18 years and up

Part 1 Open-label Extension:

  • Patients previously enrolled in etrolizumab Phase III study GA29144 who meet the eligibility criteria for open-label etrolizumab as described in the protocol

Part 2 Safety Monitoring:

  • Patients who participated in etrolizumab Phase III study GA29144 and are not eligible or choose not to enter Part 1
  • Patients who transfer from Part 1
  • Completion of the 12-week safety follow-up period prior to entering

You CAN'T join if...

Part 1 Open-label Extension:

  • Any new, significant, uncontrolled condition

Part 2 Safety Monitoring:

  • No exclusion criteria

Locations

  • Uni. of California at San Francisco; Dept Pediatric, Div. of Gastroenterology, Hepatology & Nutri accepting new patients
    San Francisco, California, 94158, United States
  • Digestive Care Associates, A Medical Corporation not yet accepting patients
    San Carlos, California, 94070, United States
  • Ventura Clinical Trials accepting new patients
    Ventura, California, 93003, United States
  • California Medical Research Associates, Inc. terminated
    Northridge, California, 91324, United States
  • VA Long Beach Healthcare System not yet accepting patients
    Long Beach, California, 90822, United States
  • University of California, Irvine Medical Center withdrawn
    Orange, California, 92868, United States
  • Therapeutic Research Institute of Orange County terminated
    Laguna Hills, California, 92653, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02403323
Phase
Phase 3
Lead Scientist
Melvin Heyman
Study Type
Interventional
Last Updated
March 30, 2018