This study is in progress, not accepting new patients

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

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Melvin Heyman
Headshot of Melvin Heyman
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, Etrolizumab, Etrolizumab Open-Label Extension, Safety Monitoring

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
    San Francisco California 94158 United States
  • Digestive Care Associates, A Medical Corporation
    San Carlos California 94070 United States

Lead Scientist at UCSF

  • Melvin Heyman
    Professor, Pediatrics, School of Medicine. Authored (or co-authored) 323 research publications. Research interests: inflammatory bowel disease (ulcerative colitis · Crohn's disease) · Pediatric Nutrition · Pancreatitis in children (acute and chronic) · Mentoring and Career Development · Fellowship Training · Gastroesophageal Reflux Disease

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Hoffmann-La Roche
ID
NCT02403323
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 900 study participants
Last Updated