Open-Label Extension and Safety Study for Patients With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
- Autoimmune Disorder
- Crohn's Disease
Terminated
- Australia
- Austria
- Belgium
- Brazil
- Bulgaria
- Canada
- Croatia
- Czechia
- Estonia
- France
- Germany
- Hungary
- Israel
- Italy
- Latvia
- Lithuania
- Mexico
- Netherlands
- New Zealand
- Poland
- Romania
- Russia
- Serbia
- Slovakia
- South Africa
- South Korea
- Spain
- Switzerland
- Türkiye
- Ukraine
- United Kingdom
- United States
NCT02403323 2014-003855-76 GA29145
Trial 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.
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
Eligibility Criteria
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
Part 1 Open-Label Extension:
- Any new, significant, uncontrolled condition
Part 2 Safety Monitoring:
- No exclusion criteria
For the latest version of this information please go to www.forpatients.roche.com