EUCTR2012-004619-30-HU进行中（未招募）1 期
A Phase 2, Open-label Extension Study to Evaluate Long-term Safety of MEDI-546 in Adults with Systemic Lupus Erythematosus
MedImmune, LLC, a wholly owned subsidiary of AstraZeneca0 个研究点目标入组 218 人开始时间: 2013年6月28日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 218
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
- •Must provide written informed consent
- •Must have qualified for and completed study CD-IA-MEDI-546-1013
- •Must be willing to use 2 methods of effective contraception
- •Must have adequate venous access
- •Must be willing to forego other forms of experimental treatment
- •Must be able to complete the study period.
- •Has adequate reading and writing abilities to comprehend and complete the informed consent,
- •and all protocol-related subject assessments.
- •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 228
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 12
排除标准
- •-Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
- •-Major surgery within 8 weeks before signing ICF
- •-Concomitant medications within the last 12 weeks: Azathioprine greater
- •than 200mg/day, Mycophenolate mofetil/mycophenolic acid greater than 2.0g/day, oral, sc, or intramuscular methotrexate greater than 25mg/week
- •- Receipt of a live or attenuated vaccine within 4 weeks of signing the ICF
- •-Receipt of Bacillus of Calmette and Guerin (BCG) vaccine within 1 year of ICF
研究者
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