EUCTR2011-004570-28-BE进行中（未招募）1 期
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Belimumab plus Standard of Care versus Placebo plus Standard of Care in Adult Subjects with Active Lupus Nephritis - BLISS
Human Genome Sciences, Inc. (a wholly owned subsidiary of GlaxoSmithKline PLC)0 个研究点目标入组 464 人开始时间: 2012年8月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 464
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.
- •Biopsy confirmed active lupus nephritis.
- •Autoantibody-positive.
- •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 455
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 9
排除标准
- •Pregnant or nursing.
- •On dialysis within the past year.
- •Prior treatment with belimumab within the past year like what in the B cell targeted therapy.
- •Receipt of any induction therapy with CYC within the 3 months prior to the planned initiation of the current induction for the study.
- •Receipt of any B cell targeted therapy (for example, rituximab), investigational biological agent within the past year.
- •Severe active central nervous system (CNS) lupus.
- •Required management of acute or chronic infections within the past 60 days.
- •Current drug or alcohol abuse or dependence.
- •Tested positive for human immunodeficiency virus (HIV), hepatitis B, or hepatitis C.
- •History of severe allergic reaction to contrast agents or biological medicines.
研究者
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