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

Study ID

Cancer Related

Healthy Volunteers

Study Sites

  • Children’s Medical Center (Dallas, Plano, Southlake)

Sally Redden

Principal Investigator
Ashish Patel, M.D.

Official Title

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

Brief Overview

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.


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.

Participant Eligibility

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.