NCT00382837撤回3 期
A Phase III Multi-Center, OpenLabel, Follow-Up Study to Assess the Safety & Efficacy of Epratuzumab in Patients With Acute Severe SLE Flares Excluding the Renal or Neurologic Systems
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- UCB Pharma
- 试验地点
- 53
- 主要终点
- The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
研究概览
简要总结
Epratuzumab is an investigational antibody designed to help treat SLE. The purpose is to evaluate safety and long term efficacy in concert with standard SLE treatments
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Must have completed SL0003 Alleviate A through 48 weeks
排除标准
- •Development of toxicity to Epratuzumab
- •Significant protocol deviations from SL0003 Study.
结局指标
主要结局
The primary objective is to continue to gather long term safety data on patients with moderate to severe flaring SLE.
次要结局
- To continue to assess the efficacy and tolerability of epratuzumab;
- To continue to monitor the plasma concentration and immunogenicity profile of epratuzumab in patients with Lupus;
- To continue to assess epratuzumab on Health-related quality of life in lupus patients;
- To continue to assess disease status as reported by the patient and physician.
研究者
研究点 (53)
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