Post-Marketing Observational Cohort Study of Patients with Inflammatory Bowel Disease (IBD) Treated with CT-P13 in Usual Clinical Practice (CONNECT-IBD) - CONNECT-IBD

Hospira UK Ltd.0 个研究点目标入组 2,500 人开始时间: 2015年4月8日最近更新: 2019年6月30日

适应症

试验速览

暂无简介。

•1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.
•2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.
•3. Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 2380
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 120

•1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC/Product Label.
•2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.
•3. Prior history of failure to respond to Remicade or CT-P13.

发起方

Hospira UK Ltd.