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

Conditions: Pediatric patients with a confirmed diagnosis of CD or UC .
MedDRA version: 18.1Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 100000004856
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2008-005237-30-NL

Lead Sponsor: Janssen Biologics B.V.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 6000

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 with the exception of patients who participated in the Sponsor's protocol C0168T72 or C0168T62. These patients are eligible for enrollment regardless of the patients 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.

Are the trial subjects under 18? yes
Number of subjects for this age range: 6000
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 with the exception of patients who participated in the Sponsor's protocol C0168T72 or C0168T62. These patients are eligible for enrollment regardless of the patients age at the time of enrollment
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 Sponsor's trials for pediatric IBD.