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临床试验/EUCTR2014-003262-25-PT
EUCTR2014-003262-25-PT进行中(未招募)1 期

An open label, single group assignment design study to correlate soluble ST2 with clinical, endoscopic and histological activity in moderate to severe Ulcerative Colitis patients under golimumab - EVOLUTIO

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.0 个研究点目标入组 38 人开始时间: 2014年11月20日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
38

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

入选标准

  • Subjects with a diagnosis of moderate to severe ulcerative colitis will be selected to participate in the trial.
  • Age 18 years or older at time of enrollment; diagnosis of moderate to severe ulcerative colitis at inclusion (defined as a clinical Mayo score =6) including endoscopy that shows inflammation as judged by a Mayo endoscopy score =2; subject is eligible to receive golimumab as per product monograph; signed the informed consent
  • 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 37
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • as per golimumab’s product monograph; history of asthma, autoimmune
  • diseases, hypertension.

研究者

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