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

NCT01490528 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2011-12-14

No results posted yet for this study

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

Sponsors & Collaborators

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Marla Dubinsky · Cedar Sinai Medical Center

Eligibility

Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01490528 on ClinicalTrials.gov