A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn*s Disease and Ulcerative Colitis

Phase 4

Recruiting

Conditions: Crohn's disease
Ulcerative Colitis
10017969

Registration Number: NL-OMON41540

Lead Sponsor: Janssen Biologics BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1. Have a confirmed diagnosis of CD or ulcerative colitis for at least 2 months.
2. Are male or female at least 6 years of age, but less than 17 years of age with the exception of
patients who participated in the Sponsor*s Protocol C0168T72 or C0168T62 and
are 17 years of age or older. These patients are eligible for enrollment in this registry regardless of
the patient's age at the time of enrollment.
3. 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).
4. 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.

Exclusion Criteria

1. Are less than 6 years of age or 17 years of age or older with the exception of
patients who participated in the Sponsor*s Protocol C0168T72 or C0168T62 and
are 17 years of age or older.
2. The patient and parent/guardian are not able to adhere to the protocol
requirements.
3. Have other Crohn*s-like diseases that are associated with genetic diseases (eg,
glycogen storage disease).
4. Are participating in any clinical trial for an investigational agent that is not
commercially available.
5. Are currently participating in one of the sponsors trials for pediatric IBD (eg,
RESULTS [C0168T45]).

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Data will be obtained by the registry physician or designee<br /><br>every 6 months, and will include: disease characteristics; medications; dose<br /><br>and frequency of Remicade, other<br /><br>biologics, and immune modulators; clinical status; quality of life; and AEs<br /><br>(including<br /><br>dysplasias and malignancies of all types, infections, and autoimmune disease).<br /><br>The assessment of immunogenicity and potential effects of antibody formation<br /><br>will be<br /><br>evaluated in the substudy.<br /><br></p><br>

Secondary Outcome Measures