NCT00111306终止3 期
A Phase III, Randomized, Double-Blind. Placebo-Controlled, Multi-Center Study of Systemic Lupus Erythematosus With Acute Severe SLE Flares Excluding Renal or Neurological Systems
适应症
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
- 510
- 试验地点
- 18
- 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 the study is to evaluate the safety & 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
- •Has SLE by ACR revised criteria (meets <4 criteria);
- •Has SLE with at least one elevated lupus antibody;
- •Has new onset of severe lupus disease flare in at least one body or organ system, excluding renal or neurologic
排除标准
- •Active severe CNS or Renal disease defined by BILAG as Level A
- •Allergy to murine or human antibodies
- •Antiphospholid antibodies AND a history of thrombocytopenic events
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
研究点 (18)
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