EUCTR2008-005237-30-SE
Active, not recruiting
Not Applicable
A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP
ConditionsPediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollmentMedDRA version: 14.0Level: LLTClassification code 10013099Term: Disease CrohnsSystem Organ Class: 10017947 - Gastrointestinal disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
DrugsRemicade
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pediatric patients with a confirmed diagnosis of CD aged 6 years to lessthan 17 years of age at the time of enrollment
- Sponsor
- Janssen Biologics BV
- Enrollment
- 4000
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
- •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
Exclusion Criteria
- •Patients meeting any of the following criteria may not be enrolled in the
- •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]).
Outcomes
Primary Outcomes
Not specified
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