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临床试验/EUCTR2014-003733-25-FR
EUCTR2014-003733-25-FR进行中(未招募)1 期

Pilot Study related to the effect of clopidogrel on plasmatic soluble CD40 ligand during systemic lupus erythematous - CLOPUS

CHU de BORDEAUX0 个研究点目标入组 30 人开始时间: 2015年6月26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
入组人数
30

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

  • - Aged 18-65 years
  • - Diagnosis of SLE according to revised criteria of American College of Rhumatology
  • - Being affiliated to health insurance
  • - Having signed an informed consent (later than the day of inclusion and before any examination required by research)
  • 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 30
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - > 20mg/day of prednisone equivalent for > 7 days 30 days before the pre-inclusion.
  • - Diseases flare 3 months before the inclusion. A disease flare is defined by an increase of SLEDAI score >3 and or a change of the immunosuppressive treatment and or an increase of steroids dose.
  • - Is treated or has received 3 months before the pre-inclusion steroids pulses or intravenous immunoglobulins.
  • - Renal involvement that could required a kidney biopsy.
  • - Required surgery in the next 12 weeks.
  • - Has been treated by cyclophosphamide 3 months before the pre-inclusion.
  • - Has been treated by biotherapy 6 months before the pre-inclusion.
  • - Contraindication to clopidogrel (annex 1).
  • - History of cancer except healed basal cell carcinoma.
  • - History of severe hemorrhage
  • - Disease exposing to hemorrhage
  • - Associated antiphospholipid syndrome
  • - Pregnant or breastfeeding women
  • - No contraception for women of childbearing age
  • - Severe hypertension
  • - Ongoing statin, non-steroidal anti-inflammatory, antiplatelet and anticoagulant drugs.
  • - Being under guardianship

研究者

发起方
CHU de BORDEAUX

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Pilot Study related to the effect of clopidogrel on... | 临床试验