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Active Not Recruiting NCT00606346

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

Conditions: Crohn's Disease, Ulcerative Colitis, Indeterminate Colitis, Inflammatory Bowel Diseases

Sex: All
Ages: 1 Month – 17 Years
Healthy volunteers: No
Enrollment: 4970
Sponsor: Janssen Biotech, Inc.

Location: Mobile Alabama

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 Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00606346). StuddyBuddy aggregates publicly available trial information.