NCT00831649终止2 期
A Phase II, Multicenter, Open-Label, Long-Term Study of the Safety, Tolerability, and Efficacy of Intravenous Natalizumab in Subjects With Rheumatoid Arthritis Who Have Previously Participated in Study ELN100226-RA201
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Biogen
- 主要终点
- The number and proportion of subjects with AEs
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety, tolerability, and efficacy of natalizumab in subjects with active rheumatoid arthritis (RA) receiving concomitant methotrexate (MTX)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
natalizumab
Experimental
干预措施: natalizumab (Drug)
结局指标
主要结局
The number and proportion of subjects with AEs
The number and percentage of subjects who discontinue early from the study due to an AE
The number and proportion of subjects with SAEs
Assessment of clinical laboratory parameters, physical examination, and vital signs.
次要结局
未报告次要终点
研究者
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