EUCTR2005-001688-74-GB进行中（未招募）1 期
A prospective, randomized, double-blind, placebo controlled trial evaluating the effects of Mycophenolate Mofetil (MMF) on 'surrogate markers' for atherosclerosis in female patients with systemic lupus erythematosus (SLE) - MMF in SLE (Missile)
Guy's & St Thomas' NHS Foundation Trust0 个研究点目标入组 70 人开始时间: 2005年8月16日最近更新:
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
- 70
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
入选标准
- •1) Female SLE patients
- •2) Age 18-50 years
- •3) Premenopausal using a reliable method of contraception
- •4) Clinically stable disease
- •5) Taking hydroxychloroquine and up to 15mgs of prednisolone daily
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Smokers
- •2) Pregnancy or breast feeding
- •3) Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
- •4) Use of any investigational drug within 1 month prior to screening
- •5) Acute infections 2 weeks prior to Visit 1
- •6) History of ischaemic heart disease or end stage renal disease
- •7) Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease.
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