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临床试验/DRKS00012509
DRKS00012509已完成不适用

Biomonitoring of inflammation, therapy response and regeneration in patients with rheumatoid arthritis, axial spondyloarthritis and psoriatic arthritis during therapy with Certolizumab Pegol - BIORAC

Charité Campus Charité Mitte0 个研究点目标入组 137 人开始时间: 2018年1月8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
137

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

  • The enrollment ensued according to the prescribing information of the medication CTZ. Every patient has to fulfill the following inclusion criteria:
  • diagnosis in RA (ACR classification criteria), SpA (ASAS criteria) and PsoA (CASPAR)
  • Is capable of understanding and signing an informed consent form
  • An active RA and PsoA DAS28 = 3,2; active spondyloarthritis with BASDAI = 4 and spinal pain =4 (NRS)
  • Fulfilling the DGRh cirteria for the indicated therapy
  • With contraception in woman of child-bearing age during the time of treatment and at least up to 5 months after the last application

排除标准

  • If there will be one of the following exclusion criteria applicable, the patient can´t enroll in the study
  • Heart failure (NYHA III/IV)
  • Active tuberculosis
  • Contraindication for the treatment with CTZ or a hypersensitivity against the contents
  • Recent therapy with Anakinra or Abatacet, or in combination with CTZ is planed
  • Is female and capable of bearing children and use any reasonable contraception

研究者

发起方
Charité Campus Charité Mitte

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