SLCTR/2015/002暂停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
Anthera Pharmaceuticals, Inc0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Fulfill at least 4 diagnostic criteria for SLE defined by American College of Rheumatology (in addition to criteria 2 and 3 below)
- •2. Positive antinuclear antibodies (ANA) and/or anti-double stranded DNA (anti-dsDNA)
- •3. Active SLE disease as defined by SELENA-SLEDAI score >10 despite on-going stable corticosteroid therapy
- •4. 18 years of age or older
排除标准
- •1. Severe active vasculitis, active central nervous system lupus, active lupus nephritis, uncontrolled hypertension or poorly controlled diabetes
- •2. Malignancy within past 5 years
- •3. Known to be positive for HIV and/or positive at the screening visit for hepatitis B, or hepatitis C
- •4. Liver disease
- •5. Anemia, neutropenia, or thrombocytopenia
- •6. Active infection requiring hospitalization or treatment with parenteral antibiotics within the past 60 days or history of repeated herpetic viral infections
- •7. History of active tuberculosis or a history of tuberculosis infection
- •8. Pregnant or nursing
研究者
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