Pediatric Inflammatory Bowel Disease
Conditions
Keywords
Pediatric IBD
Brief summary
There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children. The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab. The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab. Safety outcomes will focus on frequency of malignancies, infections and immunogenecity
Interventions
None listed
Sponsors
Cedars-Sinai Medical Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab | 10 years |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of concomitant immunomodulator use in children on infliximab | 10 years |
| Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators | 10 years |
Contacts
Primary ContactMarla Dubinsky, MD
Outcome results
None listed