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

NCT01490528 | Unknown

• 1 other identifier: REMICADEIBD4008
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Conditions

Pediatric Inflammatory Bowel Disease

Keywords

Pediatric IBD

Outcome Measures

Primary Outcomes (1)

• Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab

  10 years

Secondary Outcomes (2)

• 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

Eligibility Criteria

• Age: Up to 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• not exposed to infliximab

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Officials

• Marla Dubinsky

  Cedar Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marla Dubinsky, MD

CONTACT

dubinskym@csmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Pediatric IBd Center

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 13, 2011
• Study Start: January 1, 2012
• Last Updated: December 14, 2011

Record last verified: 2011-12