NCT01101802已完成4 期
A Prospective, Randomised, Double-blind, Placebo-controlled Trial Evaluating the Effects of Mycophenolate Mofetil on 'Surrogate Markers' for Atherosclerosis in Female Patients With SLE.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Flow mediated dilation
研究概览
简要总结
Systemic lupus erythematosus (SLE) is an independent risk factor for atherosclerosis. Endothelial dysfunction is the earliest marker of atherosclerosis and is measured by flow mediated dilation (FMD) of the brachial artery. The purpose of the study was to measure FMD in mild, stable SLE patients and look for change in FMD with the immunosuppressant drug mycophenolate mofetil (MMF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female SLE patients
- •Age 18-60 years
- •If premenopausal using a reliable method of contraception
- •Clinically stable disease
- •Taking hydroxychloroquine and up to 15mgs of prednisolone daily
排除标准
- •Pregnancy or breast feeding
- •Use of other immunosuppressants (hydroxychloroquine and stable dose of prednisolone up to 15 mgs daily will be permitted)
- •Use of any investigational drug within 1 month prior to screening
- •Acute infections 2 weeks prior to Visit 1
- •History of ischaemic heart disease or end stage renal disease
- •Current signs or symptoms of severe, progressive or uncontrolled hepatic, haematological, gastroenterological, endocrine, pulmonary, cardiac or neurological disease
研究组 & 干预措施
Mycophenolate mofetil
Active Comparator
Patients were given 1gm bd mycophenolate mofetil for 8 weeks
干预措施: Mycophenolate mofetil (Drug)
Sugar pill
Placebo Comparator
干预措施: sugar pill (Drug)
结局指标
主要结局
Flow mediated dilation
时间窗: 8 weeks
Measure of endothelial function using doppler ultrasound to measure brachial artery dilation in response to increase blood flow.
次要结局
- BILAG, SLEDAI,(8 weeks)
研究者
研究点 (1)
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