NCT00203151终止2 期
A Multi-National, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Parallel Group Study to Assess the Efficacy, Tolerability and Safety of Edratide for Subcutaneous Injection in Systemic Lupus Erythematosus (SLE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 340
- 主要终点
- Improvement of Disease Activity Score
研究概览
简要总结
It is thought that Edratide may be able to reduce the symptoms of SLE.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to give written informed consent
- •Between the ages of 18 and 65 years (inclusive)
- •Fulfilled at least 4 ACR classification criteria
- •SLE patients with moderate, active disease
- •Subjects on stable dose of SLE medications for at least 4 weeks before randomization.
- •Women of child-bearing potential must practice a medically acceptable method of contraception..
- •Must understand the requirements of the study and agree to comply with the study protocol.
排除标准
- •Any condition which the investigator feels may interfere with participation in the study.
- •Subjects having a history of chronic infection
- •Subjects with a history of immunodeficiency syndrome or malignancy,
- •Subjects who received any investigational medication (including DHEA) within 3 months prior to randomization,
- •Subjects treated with any cytotoxic agents in the 3 months prior to randomization.
研究组 & 干预措施
1
Experimental
干预措施: edratide (Drug)
2
Placebo Comparator
干预措施: edratide (Drug)
结局指标
主要结局
Improvement of Disease Activity Score
时间窗: 30 weeks
次要结局
未报告次要终点
研究者
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