NCT00276172已完成3 期
An Open-Label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Natalizumab in Subjects With Multiple Sclerosis Who Have Completed Studies C-1801, C-1802, or C-1803
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,615
- 试验地点
- 1
- 主要终点
- The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
研究概览
简要总结
The primary objective of this study is to determine the safety and the immunogenicity of extended treatment with natalizumab when administered at a dose of 300 mg intravenously (IV) to subjects with multiple sclerosis (MS) who have completed natalizumab Studies C-1801, C-1802, or C-1803.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent.
- •Must be an MS subject who has completed natalizumab Study C-1801, C-1802 or C-1803
排除标准
- •History of, or available abnormal laboratory results, indicative of any significant disease that would preclude treatment.
- •History of severe allergic or anaphylactic reactions or known drug hypersensitivity
- •A clinically significant infectious illness within 30 days prior to study entry.
研究组 & 干预措施
Natalizumab
Experimental
Open-label natalizumab
干预措施: Natalizumab (Drug)
结局指标
主要结局
The safety endpoints under consideration will be the incidence of adverse events, changes in laboratory evaluations, vital signs, and physical examinations. The incidence of development of antibodies to natalizumab will also be assessed.
时间窗: Month 24
次要结局
- EDSS scores and assessments of relapse.(Month 24)
研究者
研究点 (1)
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