NL-OMON41540
Recruiting
Phase 4
A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn*s Disease and Ulcerative Colitis - Registry REMICADE PIB4002
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Crohn's disease
- Sponsor
- Janssen Biologics BV
- Enrollment
- 200
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
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,
Outcomes
Primary Outcomes
Not specified
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