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
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.
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
- 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)
- SF-36 PCS, MCS(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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