A Multicenter, Prospective, Long-term Registry of children with Crohn's Disease

Conditions: Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment
MedDRA version: 14.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 10017947 - Gastrointestinal disorders
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2008-005237-30-SE

Lead Sponsor: Janssen Biologics BV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 4000

Inclusion Criteria

1. Have a confirmed diagnosis of CD for at least 2 months.
2. Are male or female at least 6 years of age, but less than 17 years of
age.
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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria may not be enrolled in the
registry:
1. Are less than 6 years of age or 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 a Centocor-sponsored trial for pediatric
CD (eg, RESULTS [C0168T45]).

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The objective of this registry is to obtain long-term safety and clinical<br>status<br>information on pediatric patients with CD.;Secondary Objective: ;Primary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable

Secondary Outcome Measures