EUCTR2011-005667-25-HU进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled 52-Week Studyto Assess Adverse Events of Special Interest in Adults with Active, Autoantibody-Positive Systemic Lupus Erythematosus Receiving Belimumab
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,018
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
- •Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- •Active SLE disease.
- •Autoantibody-positive.
- •On stable SLE treatment regimen which may include corticosteroids (for example, prednisone), antimalarial (for example, hydroxychloroquine) and/or immunosuppressants (for example, azathioprine, methotrexate, mycophenolate).
- •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 3700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •Pregnant or nursing.
- •Have received treatment with any of the following: belimumab, either as a marketed product or as an investigational agent; any B cell targeted therapy (for example, rituximab) in the past year; or any biological agent (for example, adalimumab, etanercept, infliximab, or anakinra) in the past 90 days.
- •Have received a live vaccine within the past 30 days.
- •Have severe active lupus kidney disease.
- •Have severe active central nervous system (CNS) lupus.
- •Current or past positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
研究者
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