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
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