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Active, not recruiting Observational

A Multicenter, Prospective, Long-term, Observational Registry of Pediatric Patients With Inflammatory Bowel Disease

NCT00606346 · tracked via the Priya Life Science USA tracker
Sponsor
Janssen Biotech, Inc
Phase
Observational
Started
2007-05-31
Last updated
2026-11-03

Condition(s) studied

Crohn's DiseaseUlcerative ColitisIndeterminate ColitisInflammatory Bowel Diseases

Investigational drug(s) / intervention(s)

Anti TNF therapy including infliximabNo Biologics

Anti TNF therapy including infliximab: Treatments will be prescribed according to investigator judgement.

No Biologics: Treatments will be prescribed according to investigator judgement.

Study summary

The purpose of this study is to evaluate the long-term safety and clinical status of pediatric patients with Inflammatory Bowel Disease (IBD). Particular attention will be directed to recording safety outcomes reported in association with infliximab and other prescribed IBD therapies. In addition, information on disease status and quality of life will be collected.

Eligibility

Sex
ALL
Min age
1 Month
Max age
17 Years
Healthy volunteers
No
Inclusion Criteria: C0168Z02 - Confirmed diagnosis of Crohn's disease, Ulcerative Colitis, or Indeterminate Colitis for at least 2 months The parent/legal guardian must be capable of providing written informed consent, and assent should be obtained from the child according to local regulations (age at which assent is given may vary by the IRB or EC). The patient's physician expects the patient to be scheduled for a medical encounter (and/or other direct contact) at least every 6 months, as part of their usual care, at the time of enrollment. REMICADEPIB4002 and REMICADEPIB4003: Confirmed diagnosis of Crohn's disease or Ulcerative Colitis for at least 2 months Exclusion Criteria: C0168Z02: 17 years of age or older, with the exception of patients who participated in the Sponsor's conducted pediatric IBD clinical trials. Have other Crohn's-like diseases that are associated with genetic diseases (eg, glycogen storage disease). The patient and parent/guardian are not able to adhere to the protocol requirements. Are participating in any clinical trial for an investigational agent that is not commercially available. REMICADEPIB4002 and REMICADEPIB4003: Less than 6 years of age or 17 years of age or older.

Primary outcome measure(s)

  • Obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or indeterminate colitis [IC]). — This is a 20-year registry that has visits every 6 months.
    The objective of this registry is to obtain long-term safety and clinical status information on pediatric patients with IBD (ie, CD, UC, or IC).

Trial sites (62)

FacilityCityRegionStatus
— Mobile Alabama
— Phoenix Arizona
— Los Angeles California
— Oakland California
— Sacramento California
— San Diego California
— San Francisco California
— Aurora Colorado
— Hartford Connecticut
— New Haven Connecticut
— Gainesville Florida
— Miami Florida
— Orlando Florida
— Atlanta Georgia
— Boise Idaho
— Chicago Illinois
— Lexington Kentucky
— New Orleans Louisiana
— Portland Maine
— Boston Massachusetts
— Newton Massachusetts
— Worcester Massachusetts
— Detroit Michigan
— Southfield Michigan
— Minneapolis Minnesota
— Rochester Minnesota
— Boys Town Nebraska
— Las Vegas Nevada
— Manchester New Hampshire
— Mays Landing New Jersey
— Morristown New Jersey
— Brooklyn New York
— Buffalo New York
— Lake Success New York
— Mineola New York
— New York New York
— Stony Brook New York
— Syracuse New York
— The Bronx New York
— Williamsville New York

+ 22 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00606346 on ClinicalTrials.gov ↗ ← All trials in the USA