Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience
|ClinicalTrials.gov Identifier: NCT01490528|
Recruitment Status : Unknown
Verified December 2011 by Marla Dubinsky, Cedars-Sinai Medical Center.
Recruitment status was: Not yet recruiting
First Posted : December 13, 2011
Last Update Posted : December 14, 2011
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 or disease|
|Pediatric Inflammatory Bowel Disease|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Study Start Date :||January 2012|
- Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab [ Time Frame: 10 years ]
- Frequency of concomitant immunomodulator use in children on infliximab [ Time Frame: 10 years ]
- Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators [ Time Frame: 10 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01490528
|Contact: Marla Dubinsky, MDfirstname.lastname@example.org|
|Principal Investigator:||Marla Dubinsky||Cedar Sinai Medical Center|