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

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  TYSABRI
• Study drug International non-proprietary name (INN) or common name:
  NATALIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG03) natalizumab

  natalizumab
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  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.
• Outcomes:
  - Percentage of Participants in Natalizumab-Naive and Other MS mAb-Naive Cohort who Start Taking Natalizumab Injections and Develop Anti-Natalizumab Antibodies (ANAs);; - Percentage of Participants in Natalizumab-Experienced Cohort who Switched From Natalizumab IV Infusion to SC Injection and Develop Anti-Natalizumab Antibodies (ANAs);; - Percentage of Participants With SAEs by Positive (Transient or Persistent) or Negative ANA Status;; - Percentage of Participants With MS Relapses by Positive (Transient or Persistent) or Negative ANA Status.
• Data analysis plan:
  Descriptive analyses will be performed to characterise the study population (RRMS patients). Summary statistics such as mean and standard deviation for continuous characteristics and frequency tables for categorical characteristics will be provided.