NCT00383214终止3 期
A Phase III, Randomized, Double Blind, Placebo Controlled, Multi-Center Study of Epratuzumab in Patients With Active Systemic Lupus Erythematosus.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- UCB Pharma
- 入组人数
- 54
- 主要终点
- Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Epratuzumab with standard treatments for patients with 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
- Double
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
- •+ANA at screening
- •BILAG Index B Level Activity in at least 2 body systems/organs
- •Has SLE by ACR revised criteria (meets,<4 criteria)
排除标准
- •Active Severe Lupus as defined by BILAG Index Level A in any body system or organ.
- •Allergy to human antibodies or Murine.
研究组 & 干预措施
Epratuzumab
Active Comparator
360 mg/m2 or 720 mg/m2 delivered by slow intravenous infusion
干预措施: Epratuzumab (Drug)
Placebo
Placebo Comparator
Intravenous
干预措施: Placebo (Other)
结局指标
主要结局
Patient response variable (complete response, partial response, non-response) evaluated at 24 weeks
次要结局
- Proportion of patients with complete response or partial response;
- Individual BILAG assessments;
- Physician and patient assessment scores;
- Time-to treatment failure;
- Successful steroid reduction by weeks 20 and 24;
- Maintenance of steroid reduction at 24 and 48 weeks;
- Monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
- Assess epratuzumab on Health-related quality of life
研究者
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