EUCTR2016-001948-19-IT进行中(未招募)1 期
A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Subcutaneous Abatacept in Adults with Active Primary Sj¿grens Syndrome -
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 249
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
- •- ESSDAI score of at least 5
- •- Positive anti-SS-A/Ro antibody at screening
- •- Meet the proposed 2015 ACR/EULAR Classification Criteria for
- •Sjögren's Syndrome
- •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 287
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •- Secondary sjogrens syndrome
- •- Active life-threatening or organ-threatening complications of
- •Sjögren's-syndrome
- •- Other medical condition associated with sicca syndrome
研究者
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