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

Pediatric Inflammatory Bowel Disease Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01490528
• Other study ID #: REMICADEIBD4008
• Status: Not yet recruiting
• Phase: N/A
• First received: December 7, 2011
• Last updated: December 12, 2011
• Start date: January 2012

Study information

• Verified date: December 2011
• Source: Cedars-Sinai Medical Center
• Contact: Marla Dubinsky, MD
• Email: dubinskym[@]csmc.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases
• Pediatric Inflammatory Bowel Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab		10 years	Yes
Secondary	Frequency of concomitant immunomodulator use in children on infliximab		10 years	No
Secondary	Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators		10 years	Yes