A Multicenter, Prospective, Long-term Registry of Pediatric Patients with Crohn*s Disease and Ulcerative Colitis - Registry REMICADE PIB4002

Janssen Biologics BV0 个研究点目标入组 200 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

暂无简介。

•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
•usual care, at the time of enrollment.

•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,
•RESULTS [C0168T45]).

发起方