Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience

Cedars-Sinai Medical Center

Status: Unknown

Conditions: Pediatric Inflammatory Bowel Disease

Study type: Observational

Funder types: Other

Identifiers

NCT01490528

REMICADEIBD4008

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: Under 21 years old

Volunteers: No Healthy Volunteers

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