At a glance
ClinicalIndex Comparison RecordN/ACompleted· 2,239 enrolled
Drug / intervention
infliximab +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ulcerative Colitis European Registry: A Prospective, Observational, Non-interventional, Post-Marketing Safety Surveillance Program
In Brief
An observational study evaluating infliximab and Standard Therapy for Ulcerative Colitis. Completed, enrolled 2,239 participants.
Detailed Summary
This is a prospective, safety surveillance registry in participants with moderate-to-severe active ulcerative colitis (UC).
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
Countries--
CollaboratorsCentocor, Inc.
Timeline
N/ACompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJun 2007
First PostedJun 2008
Primary CompletionOct 2016
TodayJul 2026
First PostedJun 26, 2008
Enrollment StartJun 1, 2007
Primary CompletionOct 20, 2016
TodayJul 2, 2026
Enrollment to primary: 9.4 yearsPosted 18.0 years ago
Interventions
infliximabbiological
The treating physician will determine the treatment regimen and dose of Remicade.
Standard Therapydrug
The standard therapy group will consist of participants receiving a treatment regimen that does not include Remicade. The treatment of each standard therapy participant will be left to the discretion of the treating physician and may change during the course of a participant's participation in the registry.