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临床试验/DRKS00005940
DRKS00005940已完成不适用

Early MOnitoring of REsponse on the therapy of Golimumab (GLM) with fecal calprotectin and trough serum levels in patients with ulcerative colitis. A multicentric, prospective study - MORE

GISG Organisationsbüro Kompetenznetz Darmerkrankungen0 个研究点目标入组 61 人开始时间: 2014年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
61

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • 1. Established diagnosis of ulcerative colitis by endoscopical and clinical determination
  • 2. Trial-independend treatment with golimumab according to routine local prescribing practice at the discretion of the investigator
  • 3. Minimum age of 18 years
  • 4. The patient must be capable in communicating sufficiently in German
  • 5. The patient must be able to recognize the nature, significance and scope of the study and must agree in a written informed consent.
  • 6. Increased level of calprotectin (=100 mg/l or =100 mg/kg) within 3 weeks prior to inclusion or existing endoscopic record of a distinct inflammatory response (UCEIS = 3 points).

排除标准

  • 1. Infectious colitis
  • 2. Treatment with Golimumab outside the label
  • 3. Treatment with Golimumab within the last 3 month

研究者

发起方
GISG Organisationsbüro Kompetenznetz Darmerkrankungen

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