SISTER - Subcutaneous: Non-Interventional Study for Tysabri Patient Preference - Experience From Real World
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 318
- 试验地点
- 40
- 主要终点
- Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
研究概览
简要总结
The primary objective of this study is to collect, evaluate and compare data on participant preference between subcutaneous (SC) and intravenous (IV) natalizumab. The secondary objectives of this study are to evaluate the immunogenicity of SC natalizumab for natalizumab-naïve participants and collect and evaluate data on the multiple sclerosis (MS) disease-relevant parameters (relapse rate, time to first relapse, disability improvement and progression) over 12 months, in participants with natalizumab therapy starting on SC natalizumab or switching from IV natalizumab.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Diagnosis of highly active RRMS according to McDonald criteria (2018) and initiating natalizumab treatment is indicated based on current summary of product characteristics (SmPC)
- •In RRMS participants who are already on natalizumab therapy, continued treatment must be indicated based on current SmPC
排除标准
- •Progressive forms of MS
- •Contraindication to natalizumab treatment according to natalizumab SmPC
- •Concomitant treatment with other drugs for treating RRMS
- •Participation in any interventional clinical trial NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
On Natalizumab: Switcher IV to SC Cohort
Participants who are already on natalizumab treatment, 300 milligrams (mg) IV infusion and who decide to switch to 2x150 mg SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
干预措施: Natalizumab (Drug)
Natalizumab-Naive IV Cohort
Participants who initiate natalizumab, 300 mg, IV infusion injection administered as standard of care/routine clinical practice will be observed for up to 12 months
干预措施: Natalizumab (Drug)
Natalizumab-Naive SC Cohort
Participants who initiate natalizumab, 2x150 mg, SC injection administered as standard of care/routine clinical practice will be observed for up to 12 months.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 6
时间窗: Month 6
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
Number of Participants by Their Preferred Method of Natalizumab Administration at Month 12
时间窗: Month 12
The participant preference will be measured by Patient preference questionnaire (PPQ) 1. PPQ 1 comprises of 3 questions - 1. "Are you satisfied with the route of administration of natalizumab?" (yes/no) and indicate main reason. 2. For SC participants only- "Have you experienced adverse events related to a subcutaneous injection." (1= mild to 5 = severe), and 3. "If you had to choose between subcutaneous or intravenous route again, which route would you choose?".
次要结局
- Number of Participants With Disability Improvement and Progression who Switch to Subcutaneous Natalizumab(Baseline, Months 3, 6, 9, and 12)
- Number of Participants Positive for Anti-Natalizumab-Antibody(Baseline, Month 6 and 12)
- Percentage of Participants Persistently Positive for Anti-Natalizumab-Antibody(Baseline, Month 6 and 12)
- Time to Relapse(Baseline, Months 3, 6, 9, and 12)
- Annual Relapse Rate(Baseline, Months 3, 6, 9, and 12)