Trial Information
Inclusion Criteria:
- All individuals who received at least 2 doses of infliximab before the age of 16 at
the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's
disease or ulcerative colitis Able to give consent
Exclusion Criteria:
- not exposed to infliximab
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Retrospective
Outcome Measure:
Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab
Outcome Time Frame:
10 years
Safety Issue:
Yes
Principal Investigator
Marla Dubinsky
Investigator Role:
Principal Investigator
Investigator Affiliation:
Cedar Sinai Medical Center
Authority:
United States: Institutional Review Board
Study ID:
REMICADEIBD4008
NCT ID:
NCT01490528
Start Date:
January 2012
Completion Date:
Related Keywords:
- Pediatric Inflammatory Bowel Disease
- Pediatric IBD
- Inflammatory Bowel Diseases
- Intestinal Diseases