EUCTR2008-005237-30-SEActive, not recruitingNot Applicable
A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn's Disease - DEVELOP
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Janssen Biologics BV
- Enrollment
- 4,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
- •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]).
Investigators
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