NCT01395745已完成3 期
A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy and Safety of Blisibimod Administration in Subjects With Systemic Lupus Erythematosus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 442
- 试验地点
- 90
- 主要终点
- Proportion of patients achieving an SLE Responder Index at week 52
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of subcutaneous blisibimod administered in addition to standard therapy in subjects with active Systemic Lupus Erythematosus (SLE) disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy.
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
- •Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology
- •Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
- •Active SLE disease as defined by SELENA-SLEDAI score ≥10 despite on-going stable corticosteroid therapy
- •18 years of age or older
排除标准
- •Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes
- •Malignancy within past 5 years
- •Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
- •Liver disease
- •Anemia, neutropenia, or thrombocytopenia
- •Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
- •History of active tuberculosis or a history of tuberculosis infection
- •Pregnant or nursing
研究组 & 干预措施
blisibimod weekly dose
Experimental
干预措施: blisibimod (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Proportion of patients achieving an SLE Responder Index at week 52
时间窗: Week 52
次要结局
- Time to first severe SLE flare(Week 52)
- Proportion of subjects able to reduce oral steroid dose to ≤7.5 mg/day prednisone(Week 52)
- Change in the number of actively tender or swollen joints and in mucocutaneous disease activity(Week 52)
- Change in proteinuria from baseline(Week 52)
- Safety Profile (AEs, vital signs, labs, physical exams)(Week 52)
- Time to first renal flare(Week 52)
- Change from baseline in B cell subsets, anti dsDNA, C3, C4(Week 52)
- Proportion of subjects with improved patient-reported outcomes(Week 52)
- Time to treatment failure(Week 52)
研究者
研究点 (90)
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