An Observational Study Utilising Data From EU National MS Registries to Estimate the Incidence of Anti-Natalizumab Antibody Among Patients Who Receive Subcutaneous Administration of Natalizumab for Treatment of RRMS
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Biogen
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)
研究概览
简要总结
The primary objective of this study is to estimate the incidence of Anti-Natalizumab Antibodies (ANAs) in the cohort of natalizumab-naïve and other MS monoclonal antibody (mAb)-naive participants who start receiving natalizumab subcutaneous (SC) injections. The secondary objectives of this study are to estimate the proportion of participants detected with ANAs when switched from natalizumab intravenous (IV) to natalizumab SC (natalizumab-experienced cohort); to evaluate serious adverse events (SAEs), including injection reactions and hypersensitivity reactions, by ANA status and to assess the proportion of participants who had MS relapse, by ANA status.
详细描述
The study will collect data prospectively and retrospectively.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who are natalizumab-naïve and other MS mAb-naive and who start on natalizumab SC.
- •Participants who have previously received natalizumab IV and switch from natalizumab IV to SC administration.
排除标准
- •For the natalizumab-naive and other MS mAb-naive cohort, participants who previously received natalizumab or other MS mAbs will be excluded.
- •For the natalizumab-experienced cohort, participants who are naive to natalizumab will be excluded.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Cohort 2: Natalizumab Experienced
Per standard of care, participants with MS enrolled in selected MS registries, who have previously received natalizumab IV will be switched from natalizumab IV to SC administration to receive natalizumab 300 mg, SC injection according to decision of the treating physician.
干预措施: Natalizumab (Drug)
Cohort 1: Naive Participants
Per standard of care, participants with MS enrolled in selected MS registries, who are natalizumab-naïve and other MS mAb-therapy-naive will receive natalizumab 300 mg, SC injection according to decision of the treating physician.
干预措施: Natalizumab (Drug)
结局指标
主要结局
Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)
时间窗: Up to 1.75 years
次要结局
- Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs)(Up to 1.75 years)
- Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status(Up to 1.75 years)
- Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status(Up to 1.75 years)