jRCT2080223306已完成2 期
A Multi-center, Randomized, Placebo-Controlled Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of Belimumab, a Human Monoclonal Anti-BLyS Antibody, Plus Standard Therapy in Pediatric Patients With Systemic Lupus Erythematosus
GlaxoSmithKline K.K.1 个研究点目标入组 100 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 干预模型
- Randomized Controlled Trial double Blind placebocontrol parallel Assignment
- 主要目的
- Treatment Purpose
入排标准
- 年龄范围
- 5age old over 至 17age old under（—）
- 性别
- All
入选标准
- •5 years to 17 years of age at enrollment
- •Have a clinical diagnosis of SLE according to the American College of Rheumatology (ACR) classification criteria.
- •Have active SLE disease (SELENA SLEDAI score >- 6).
- •Have positive anti-nuclear antibody (ANA) test results.
- •Are on a stable SLE treatment regimen at a fixed dose for a period of at least 30 days prior to Day
- •Females of childbearing age are willing to use appropriate contraception
- •Subject age appropriate assent and parent or legal guardian informed consent to participate
排除标准
- •Pregnant or nursing.
- •Have received treatment with belimumab (BENLYSTA(Registered Trademark)) at any time. (BENLYSTA is a registered trademark of the GSK group of companies.)
- •Treatment with any B cell targeted therapy (for example, rituximab) or an investigational biological agent in the past year.
- •Have received anti-TNF therapy; Interleukin-1 receptor antagonist; IVIG; or plasmapheresis within 90 days of Day
- •Have received high dose prednisone or equivalent (>1.5mg/kg/day) within 60 days of baseline.
- •Have received intravenous (IV) cyclophosphamide within 60 days of Day
- •Have received any new immunosuppressive/immunomodulatory agent, anti-malarial agent within 60 days of baseline.
- •Have severe lupus kidney disease.
- •Have active central nervous system (CNS) lupus.
- •Have had a major organ transplant.
- •Have significant unstable or uncontrolled acute or chronic diseases or conditions not due to SLE.
- •Have a planned surgical procedure.
- •History of malignant neoplasm within the last 5 years.
- •Have required management of acute or chronic infections in the past 60 days.
- •Have current drug or alcohol abuse or dependence.
- •Have a historically positive test, or test positive at screening for HIV, Hepatitis B, or Hepatitis C.
- •Have an IgA deficiency.
- •Have severe laboratory abnormalities.
- •Have had anaphylactic reaction to X-ray contrast agents or biologic agents.
- •Suicidal behavior or ideation.
- •Children in Care(CiC): a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
结局指标
主要结局
-
efficacy Percentage of Participants With SLE Responder Index (SRI) Response at Week 52
次要结局
未报告次要终点
研究者
研究点 (1)
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