Status:
COMPLETED
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
Lead Sponsor:
Janssen Research & Development, LLC
Collaborating Sponsors:
Janssen Biologics BV
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
Brief Summary
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
Detailed Description
This is a long term, multicenter, international safety study to evaluate targeted long-term safety information on patients who have participated in infliximab(Remicade) clinical studies in ulcerative ...
Eligibility Criteria
Inclusion
- All patients enrolled in three Phase 3 Janssen-sponsored (C0168T37, C0168T46, C0168T72) infliximab clinical studies in ulcerative colitis that require long-term safety follow-up
- Patients must have received at least 1 dose of study agent to be eligible for participation in the study
Exclusion
- \- Patients who refuse consent or are unwilling to respond to requests for long-term safety information within the required timeframe will be excluded. In addition, patients participating in a study extension to the primary study are not eligible for participation in the C0168T62 study during the study extension participation
Key Trial Info
Start Date :
August 31 2004
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2015
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT00207688
Start Date
August 31 2004
End Date
September 9 2015
Last Update
July 6 2018
Active Locations (102)
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1
Scottsdale, Arizona, United States
2
Anaheim, California, United States
3
Los Angeles, California, United States
4
Oakland, California, United States