NCT01534403已完成2 期
A Phase 2, Multicenter, Open-label, Long-term, Extension Study to Assess the Safety of Epratuzumab Treatment in Japanese Subjects With Systemic Lupus Erythematosus
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 17
- 试验地点
- 7
- 主要终点
- Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)
研究概览
简要总结
The study is an open-labeled extension study to continue to assess the safety and tolerability of Epratuzumab in moderate to severe SLE subjects who have previously participated in SL0026 [NCT01449071] phase I/II trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has completed the double-blind study SL0026 [NCT01449071] or terminated prematurely at Week 8 or later in SL0026 [NCT01449071] due to lack of efficacy
- •Women of childbearing potential must agree to use an acceptable method of birth control/Written Informed Consent
排除标准
- •Subjects with active, severe SLE disease activity which involves the renal system and active, severe, neuropsychiatric SLE, defined as any neuropsychiatric element scoring British Isles Lupus Assessment Group Index (BILAG) level A
- •Subjects with concurrent relevant medical conditions like defined chronic infections or high risk of new significant infections
- •Substance abuse or dependence
- •Significant hematologic abnormalities
- •History of malignant cancer
- •Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion
结局指标
主要结局
Number of subjects reporting at least 1 Adverse Event (AE) during the Treatment Period (maximum 100 weeks)
时间窗: up to Week 100
Change from Baseline in levels of total B Cells in the peripheral blood circulation at Week 96
时间窗: From Baseline (Week 0) to Week 96
次要结局
- Number of subjects reporting anti-Epratuzumab in plasma at Week 96(Week 96)
- Epratuzumab plasma concentration at Week 96(Week 96)
- Change from Baseline in levels of Monocyte in the peripheral blood circulation at Week 96(From Baseline (Week 0) to Week 96)
- Change from Baseline in levels of total T Cells in the peripheral blood circulation at Week 96(From Baseline (Week 0) to Week 96)
- Change from Baseline in levels of NK-Cells (Natural Killer-Cells) in the peripheral blood circulation at Week 96(From Baseline (Week 0) to Week 96)
研究者
研究点 (7)
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