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.
The study will collect data prospectively and retrospectively.
Study Type
OBSERVATIONAL
Enrollment
400
Administered as specified in the treatment arm.
Research Site
Cambridge, Massachusetts, United States
Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs)
Time frame: Up to 1.75 years
Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs)
Time frame: Up to 1.75 years
Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status
SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in permanent or significant damage to health or limitation of capabilities or is manifested as a congenital anomaly or birth defect in offspring, irrespective of the administered dose of the medicinal product.
Time frame: Up to 1.75 years
Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status
Time frame: Up to 1.75 years
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