NCT00477113已完成不适用
TYGRIS: TYSABRI® Global Observational Program in Safety
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 2,207
- 试验地点
- 1
- 主要终点
- Number of participants with serious infections, malignancies, and other SAEs
研究概览
简要总结
The Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).
详细描述
The TYSABRI Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with natalizumab in a clinical practice setting in the United States or Canada.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- 未提供
结局指标
主要结局
Number of participants with serious infections, malignancies, and other SAEs
时间窗: 5 years
次要结局
未报告次要终点
研究者
研究点 (1)
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