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临床试验/EUCTR2014-005418-45-SE
EUCTR2014-005418-45-SE进行中(未招募)1 期

Improved cardiovascular risk factors and inflammatory markers in Rheumatoid Arthritis and Systemic Lupus Erythematosus? New aspects of Hydroxychloroquine – an interventional study (HCQCVDRASLE) - HCQCVDRASLE

Christine Bengtsson0 个研究点开始时间: 2015年3月18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)
发起方

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

  • Male or female, 18-65 years of age, who has given written consent for his/her par-ticipation to the study
  • ACR criteria for RA and SLE
  • < 10mg Prednisolon daily doses
  • Low-medium disease activity DAS28 <4.6-RA, SLEDAI-2k <6 SLE (Arthritis accepted)
  • 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 44
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 4

排除标准

  • Antimalarial medication less than5 ½-t= 250 days before study inclusion visit
  • High disease activity, where cortison ad-justment is predictable
  • Pleuritis or Pericarditis – SLE
  • Impaired visus and/or colour vision
  • Hypertension >160/95
  • Short life expectancy due to other comor-bidity
  • Documented allergy or intolerance to study drug
  • Severe psychiatric condition or other reason that jeopardize compliance with fol-low up.
  • On fertile females, pregnancy assessed by anamnesis and pregnancy test

研究者

发起方
Christine Bengtsson

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