A Multicenter, Prospective, Long-Term, Observational Registry of Pediatric Patients with Inflammatory Bowel Disease

Study ID
Study00000027

Cancer Related
No

Healthy Volunteers
No

Study Sites

Contact
Maria Rocha
214-456-2671
maria.rocha@childrens.com

Principal Investigator
Ashish Patel

Summary

The registry is a multicenter, prospective, long-term, observational registry of pediatric patients with a confirmed diagnosis of iBD (inflammatory bowel disease) (i.e., CD (Crohn's Disease), uC (ulcerative Colitis), or
iC (indeterminate Colitis). Patients must be less than 17 years of age at the time of registry enrollment. The Sponsor's registry will include approximately 2,000 pediatric patients with CD who have been treated with infliximab as prescribed by their physicians. The control group for these infliximab-treated CD patients will include approximately 2,000 pediatric patients with CD who were prescribed therapies other than infliximab, likewise by their physicians. an additional 1,000 pediatric patients with uC or iC will also be enrolled. The patient enrollment period will be conducted over 24 months; the patient observation period is planned for approximately 20 years. The planned duration of the registry is approximately 22 years. The registry will be conducted at approximately 150 sites in the uS. There will be no randomized or nonrandomized treatment assignment of patients. Patient treatment will be prescribed by the physician based on usual clinical practice. There are no restrictions related to use of commercially available medications. Pediatric patients who are participating in other registries will not be excluded from participating in this registry. after the enrollment visit, data will be collected every 6 months and will include disease characteristics; medications; dose and frequency of infliximab administration; clinical status; quality of life
aes (adverse events) including dysplasias and malignancies of all types, infections, and autoimmune disease.

Participant Eligibility

1. Confirmed diagnosis for IBD for at least 2 months
2. Male or female less than 17 years of age with the exception of patients who participated in Sponsor's Protocol C0168T72 or patient who are participating in the Sponsor's Protocol C0168T62. These patients are eligible for enrollment in this registry regardless of the patient's age at the time of enrollment.
3. The parent/legal guaridan must be capable of providing written informed consent, and assent should be obtained from the child according to local regulations.
The patient's physician expects the patient to 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.