JCV Antibody Program in Patients With Relapsing Multiple Sclerosis Receiving or Considering Treatment With Tysabri®: STRATIFY-1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 1,096
- 试验地点
- 1
- 主要终点
- Number of participants with a false negative test
研究概览
简要总结
The primary objective is to define the prevalence of serum anti-JCV antibody in relapsing multiple sclerosis (MS) participants receiving Tysabri® (natalizumab) or being considered for such treatment. Secondary objectives are to analytically validate the anti-JCV antibody assay in a plasma matrix and to determine changes in anti-JCV antibody status over time.
详细描述
This study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Relapsing multiple sclerosis (MS) patients interested in or considering beginning treatment with Tysabri® (natalizumab).
排除标准
- •Patients participating in any other Tysabri® (natalizumab) clinical trial or study sponsored by Biogen Idec or Elan may not participate in this study.
- •NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Relapsing Multiple Sclerosis
Participants receiving or considering treatment with Tysabri® (natalizumab).
干预措施: Tysabri® (natalizumab) (Drug)
结局指标
主要结局
Number of participants with a false negative test
时间窗: Day 1
Confirm the false negative rate for serum anti-JCV antibody \[assay\].
Prevalence of serum anti-JC virus (JCV) antibody
时间窗: Day 1
Prevalence of anti-JCV antibodies will be estimated as the number of participants with anti-JCV antibodies detected in serum divided by the total number of participants with a serum sample that was evaluated.
次要结局
- Changes in JCV antibody status over time(Every 6 months for 2 Years)