EUCTR2011-003814-18-ES进行中（未招募）不适用
A Phase 3, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, 52-Week Study to Evaluate the Efficacy and Safety of Belimumab (HGS1006) Administered Subcutaneously (SC) to Subjects with Systemic Lupus Erythematosus (SLE) - BLISS-SC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 816
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. At least 18 years of age.
- •2. Clinical diagnosis of Systemic Lupus Erythematosus (SLE) by ACR criteria.
- •3. Active SLE disease.
- •4. Autoantibody-positive.
- •5. On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate, etc.)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 800
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 16
排除标准
- •1. Pregnant or nursing.
- •2. Have received treatment with an B cell targeted therapy (for example, rituximab or belimumab).
- •3. Have received treatment an investigational biological agent in the past year.
- •4. Have received IV cyclophosphamide within 90 days of Day 0.
- •5. Have severe active lupus kidney disease.
- •6. Have severe active central nervous system (CNS) lupus.
- •7. Have required management of acute or chronic infections within the past 60 days.
- •8. Have current drug or alcohol abuse or dependence.
- •9. Have a positive test for HIV, hepatitis B, or hepatitis C.
- •10. Have a history of hypersensitivity reactions to contrast agents or biological medicines.
研究者
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