NCT00624351已完成2 期
A Phase IIb Randomized, Double-blind, Placebo-controlled, Dose and Dose Regimen-ranging Study of the Safety and Efficacy of Epratuzumab in Serologically-positive Systemic Lupus Erythematosus (SLE) Patients With Active Disease
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
- 227
- 试验地点
- 53
- 主要终点
- Response at Week 12 according to a combined response index
研究概览
简要总结
The primary objective of the study is to assess the dose response and the dose frequency of epratuzumab in 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Positive ANA result at visit 1
- •Current diagnosis of systemic lupus erythematosus (SLE) by American College of Rheumatology revised criteria such that at least 4 of the 11 criteria are met
- •Active moderate or severe SLE disease activity as demonstrated by British Isles Lupus Assessment Group (BILAG) A level disease activity in at least one body/organ system or BILAG B level disease activity in at least two body/organ systems if no BILAG A level disease is present
- •If on antimalarials, dose regimen must be stable for 4 weeks prior to study entry.
排除标准
- •Patients receiving 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 central nervous system (CNS) (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 World Health Organization (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
Placebo
Placebo Comparator
Phosphate-buffered Saline (PBS) infusions at study weeks 0, 1, 2, and 3.
干预措施: Placebo (Other)
EMAB 100mg
Experimental
100 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
干预措施: Placebo (Other)
EMAB 400mg
Experimental
400 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
干预措施: Placebo (Other)
EMAB 1200mg
Experimental
1200 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
干预措施: Placebo (Other)
EMAB 1800mg
Experimental
1800 mg Epratuzumab infusions at study weeks 0, and 2, and placebo at study weeks 1 and 3.
干预措施: Placebo (Other)
结局指标
主要结局
Response at Week 12 according to a combined response index
时间窗: Week 12
The combined response index incorporates the Bristish Isles Lupus Assessment Group (BILAG) assessment, the Systemic Lupus Eyrthematosus Disease Activity Index (SLEDAI), a physician's global assessment of disease activity, and treatment failure status.
次要结局
- Response at Week 4 according to a combined response index(Week 4)
- Response at Week 4 according to a combined response index involving Short Form-36 (SF-36) response(Week 4)
- Response at Week 8 according to a combined response index(Week 8)
- Response at Week 8 according to a combined response index involving Short Form-36 (SF-36) response(Week 8)
- Response at Week 12 according to a combined response index involving Short Form-36 (SF-36) response(Week 12)
- Change from baseline in total British Isles Lupus Assessment Group (BILAG) score at Week 12(Baseline, Week 12)
- Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 2(Baseline, Week 2)
- Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 4(Baseline, Week 4)
- Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 8(Baseline, Week 8)
- Change from baseline in physician global assessment at Week 12(Baseline, Week 12)
- Change from baseline in patient global assessment at Week 12(Baseline, Week 12)
- Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 4(Baseline, Week 4)
- Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 8(Baseline, Week 8)
- Improvement (yes/no) in British Isles Lupus Assessment Group (BILAG) at Week 12(Baseline, Week 12)
- Improvement in British Isles Lupus Assessment Group (BILAG) at Week 24(Baseline, Week 24)
- Change from baseline in Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) at Week 12(Baseline, Week 12)
- Short Form-36 (SF-36) response at Week 2(Baseline, Week 2)
- Short Form-36 (SF-36) response at Week 4(Baseline, Week 4)
- Short Form-36 (SF-36) response at Week 8(Baseline, Week 8)
- Short Form-36 (SF-36) response at Week 12(Baseline, Week 12)
- Time to first sustained British Isles Lupus Assessment Group (BILAG) response(From Baseline to Week 12)
- European Quality of Life-5 Dimensions (EQ-5D) score at Week 12(Week 12)
- Cumulative steroid dose at Week 12(From Baseline to Week 12)
- Change from baseline in levels of circulating T cells at Week 12(Baseline, Week 12)
- Time to enhanced British Isles Lupus Assessment Group (BILAG) response(From Baseline to Week 12)
- Treatment failure up to Week 12(From Baseline to Week 12)
- Human anti-human antibodies (HAHA) levels at Week 12(Week 12)
- Change from baseline in levels of circulating B cells at Week 12(Baseline, Week 12)
研究者
研究点 (53)
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