Ireland Natalizumab (TYSABRI®) Observational Program (iTOP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 191
- 试验地点
- 1
- 主要终点
- Number of participants experiencing Serious Adverse Events (SAEs)
研究概览
简要总结
The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.
详细描述
iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must give written informed consent and assent, as applicable.
- •Decision to treat with natalizumab must precede enrollment.
- •Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information.
- •Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement.
- •Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).
- •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 experiencing Serious Adverse Events (SAEs)
时间窗: up to 3 years
次要结局
- Disability progression as determined by Expanded Disability Status Scale (EDSS)(Up to 3 years)
- MS disease activity as determined by annualized relapse rate (ARR)(Up to 3 years)
- MS disease activity as determined by distribution of the total number of relapses during the study(Up to 3 years)
- MS disease activity as determined by time to first relapse(Up to 3 years)
- MS disease activity as determined by number of participants with relapse(Up to 3 years)
- MS disability progression and MS disease activity summarized for subpopulations according to baseline characteristics(Up to 3 years)
- MS disease activity as determined by MRI parameters(Up to 3 years)
- Evaluation of short-term disease outcomes as assessed by EDSS progression(Up to 1 year)
- Evaluation of short-term disease outcomes as assessed by occurrence of relapses(Up to 1 year)