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

This study is not yet open for participant recruitment.
Verified December 2011 by Cedars-Sinai Medical Center
Sponsor:
Information provided by (Responsible Party):
Marla Dubinsky, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier:
NCT01490528
First received: December 7, 2011
Last updated: December 12, 2011
Last verified: December 2011
History of Changes
  Purpose

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


Condition
Pediatric Inflammatory Bowel Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Further study details as provided by Cedars-Sinai Medical Center:

Primary Outcome Measures:
  • Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Frequency of concomitant immunomodulator use in children on infliximab [ Time Frame: 10 years ] [ Designated as safety issue: No ]
  • Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators [ Time Frame: 10 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: January 2012
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01490528

Contacts
Contact: Marla Dubinsky, MD dubinskym@csmc.edu

Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Principal Investigator: Marla Dubinsky Cedar Sinai Medical Center
  More Information

No publications provided

Responsible Party: Marla Dubinsky, Director Pediatric IBd Center, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01490528     History of Changes
Other Study ID Numbers: REMICADEIBD4008
Study First Received: December 7, 2011
Last Updated: December 12, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Cedars-Sinai Medical Center:
Pediatric IBD

Additional relevant MeSH terms:
Inflammatory Bowel Diseases
Intestinal Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 16, 2013