EUCTR2018-001546-33-GB进行中（未招募）1 期
IBD Biosimilar to Biosimilar Infliximab Switching Study - iBiSS v1.0
niversity Southampton Hospital NHS Foundation Trust0 个研究点目标入组 200 人开始时间: 2018年5月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •The principal inclusion criteria are;
- •All patients with IBD (Crohn’s Disease and Ulcerative Colitis) treated with =1 dose of CT-P13 at time of enrolment
- •Aged =18 years at time of enrolment
- •Planned continuation of infliximab treatment for at least 3 months after enrolment
- •Capable of providing written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •Patients with the following characteristics are ineligible for this study
- •Unable to provide written informed consent
- •Involved in another IMP trial
- •Age < 18 years at time of enrolment
- •Planned discontinuation of treatment at UHS within 3 months of enrolment
研究者
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