Open-Label Extension and Safety Study for Participants 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
Melvin Heyman

Description

Summary

This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's disease who were previously enrolled in the etrolizumab Phase III Study GA29144 (NCT02394028) and who meet eligibility criteria for enrollment into Part 1. In Part 2, participants who have stopped etrolizumab treatment (either by exiting Part 1 of this study or by entering directly from Study GA29144 [NCT02394028]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (PML) and other safety events.

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 rhuMAb Beta7 Etrolizumab

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 (NCT02394028) 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 (NCT02394028) 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 accepting new patients
    San Carlos California 94070 United States

Lead Scientist

  • Melvin Heyman
    Professor, Pediatrics. Authored (or co-authored) 300 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02403323
Phase
Phase 3
Study Type
Interventional
Last Updated