NCT00637819已完成2 期
A Randomized, Double-Blind, Placebo Controlled Clinical Trial of Leflunomide in Systemic Lupus Erythematosus (SLE)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- number of patients who are able to achieve complete remission, defined as a SLEDAI of 0
研究概览
简要总结
A pilot study to evaluate the efficacy and safety of leflunomide in SLE patients with active disease who are refractory to cyclophosphamide
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fulfill the revised ACR criteria for SLE with either evidence of active disease according to SLE Disease Activity Index (SLEDAI)
排除标准
- •Patients who are pregnant or nursing women, or those with life threatening disease
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
number of patients who are able to achieve complete remission, defined as a SLEDAI of 0
时间窗: 52 weeks
次要结局
- number of patients who are able to achieve partial remission, as defined by a SLEDAI of 1-3(52 weeks)
研究者
研究点 (1)
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