NCT00390091撤回2 期
A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- using historical placebo effect as a control.
研究概览
简要总结
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.
详细描述
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females between 12 and 70 years old.
- •Diagnosis of Systemic Lupus Erythematosus (SLE)
- •Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study.
- •Ability to have weekly intravenous (IV) administration of study drug.
排除标准
- •Prior exposure to abetimus sodium within 6 months prior to screening.
- •Patients not on stable medications for 30 days prior to screening.
- •Patients with acute or chronic infections.
结局指标
主要结局
using historical placebo effect as a control.
and confirmed by supporting data. The pharmacodynamic effic will be assessed
patients with SLE will be based on laboratory data from the central laboratory
The assessment of the safety and pharmacodynamic effect of abetimus sodium at
doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in
次要结局
未报告次要终点
研究者
研究点 (4)
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