EUCTR2013-002758-62-BG进行中（未招募）1 期
A Phase IIb, Multi-Center, Long-Term Extension Trial to Evaluate the Safety and Tolerability of Atacicept in Subjects with Systemic Lupus Erythematosus (SLE) who Completed Protocol EMR-700461-023 (ADDRESS II)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Merck KGaA
- 入组人数
- 253
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
入选标准
- •- Subjects who have completed the 24-week treatment period of trial EMR-700461-023 (ADDRESS II core trial).
- •- Women of childbearing potential (WOCBP) who have a negative pregnancy test
- •- Other protocol defined inclusion criteria may apply
- •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 202
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 11
排除标准
- •- Active neurological symptoms of SLE that are deemed severe or progressive
- •- Diagnosis of any demyelinating disease, such as, but not restricted to, MS or optic neuritis
- •- Pregnancy
- •- Other protocol defined exclusion criteria may apply
研究者
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