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NCT00606346

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

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

4970 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-05-31

Study Completion Date

2038-06-30

Brief Summary

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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.

Detailed Description

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This registry study will include volunteer pediatric patients: approximately 2,000 pediatric patients with Crohn's Disease who have been treated with infliximab and approximately 2,000 pediatric patients with Crohn's Disease who have received therapies other than infliximab. Approximately 1,000 pediatric patients with Ulcerative Colitis or Indeterminant Colitis will also be enrolled. All patient treatments for IBD will be decided by the treating physicians in consultation with their patients based on usual clinical practice. Patient information will be collected at the time of enrollment and every 6 months for approximately 20 years. Data collection will include disease characteristics, IBD medications, safety assessments to include adverse events. Patients will also be asked to complete a brief questionnaire describing school and/or work attendance in order to assess quality of life. Some patients may be asked to participate in a substudy that will evaluate blood levels of formation of proteins that may develop after treatment with infliximab. A small amount of additional blood may be taken at the time of a routine blood draw that is part of a patient's routine medical care as determined by a treating physician. There are three studies as part of the post marketing requirement for IBD - C0168Z02, REMICADEPIB4002 and REMICADEPIB4003. There is one combined database for these protocols and analyses are performed using the aggregate data. All reports and publications will be generated from the combined database. No study agents will be administered in this registry. All patients will receive standard-of-care treatments prescribed by the patient's physician.

Conditions

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Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Diseases

Keywords

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Crohn's Disease Ulcerative Colitis Indeterminate Colitis Inflammatory Bowel Diseases Immunomodulators infliximab TNF-alpha

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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