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

Janssen Biologics B.V.0 个研究点目标入组 6,000 人开始时间: 2009年8月18日最近更新: 2015年12月7日

试验速览

暂无简介。

•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

•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 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.

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