NCT00660881已完成2 期
A Phase IIb Multi-Center, Open-label, Follow-up Study to Assess Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus Patients With Active Disease Who Participated in Study SL0007
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- UCB Pharma
- 入组人数
- 210
- 试验地点
- 42
- 主要终点
- Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
研究概览
简要总结
The primary objective of the study is to assess the safety of epratuzumab in patients with SLE.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •SL0007 patients who completed through week 12 of the study or who early terminated at week 8 or later due to treatment failure
- •Patients must have maintained eligibility requirements throughout their participation in SL0007
- •Written informed consent signed prior to initiation of any study-specific assessments at visit 1
排除标准
- •Patients may not receive any live vaccination within 2 weeks prior to visit 1 or during the course of the study
- •Active severe SLE disease activity which involves the CNS system (defined by BILAG neurologic A level activity) including transverse myelitis, psychosis and seizures
- •Active severe SLE disease activity which involves the Renal system (defined by BILAG renal level A activity or Grade III or higher WHO nephritis) or serum creatinine >2.5mg/dL or clinically significant serum creatinine increase within the prior 4 weeks or proteinuria >3.5gm/day
- •Patients with a history of anti-phospholipid antibody syndrome AND Use of oral anticoagulants or anti-platelet treatment
- •Patients with a history of chronic infection, recent significant infection, or any current sign of symptom that may indicate an infection.
研究组 & 干预措施
EMAB
Experimental
1200 mg epratuzumab given in 2 doses every other week in 12 week treatment cycles.
干预措施: Epratuzumab (Biological)
结局指标
主要结局
Continue to assess safety of epratuzumab by assessing adverse events (including infusion reactions), vital signs and clinical safety laboratory assessments (Timeframe: All visits)
时间窗: 12 Week treatment cycles
次要结局
- SF-36 PCS, MCS(Every 12 weeks)
- The combined response index analysis evaluating BILAG, SLEDAI, and a physician's global assessment and treatment failure status(Every 4 weeks through week 48, then every 12 weeks through completion)
- The combined response index including an additional criteria involving the SF-36 response(Every 12 weeks)
- BILAG score assessment(Every 4 weeks through week 48, then every 12 weeks through completion)
- SLEDAI scores assessment(Every 4 weeks through week 48, then every 12 weeks through completion)
- Patient and physician VAS(Every 4 weeks through week 48, then every 12 weeks through completion)
- Percentage of patients achieving SF-36 stabilization or improvement as compared to baseline(Every 12 weeks)
- EQ-5D results(Every 12 weeks)
- Proportion of patients meeting treatment failure(Every 12 weeks)
- Total daily steroid dose(Every 4 weeks for the first 48 weeks and then every 12 weeks)
- Time to flare for patients who entered the study without flare as defined by the BILAG(over the entire course of the trial)
- SLEDAI responder(Every 4 weeks for the first 48 weeks and then every 12 weeks)
- Time to sustained response for patients entering SL0008 with flare as defined by the BILAG.(over the entire course of the trial)
- Immunogenicity as measured by human anti-human antibodies(at each dosing visit and 4 weeks post first dose of each treatment cycle)
- Assessment of changes in baseline in levels of circulating B and T cells(The first dosing visit of each treatment cycle and at 4 weeks post first dose of each treatment cycle)
研究者
研究点 (42)
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