Long-Term Surveillance of Ocrelizumab Treated Patients With Multiple Sclerosis (MANUSCRIPT Study)

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

• Study drug International non-proprietary name (INN) or common name:
  OCRELIZUMAB
• Medical condition to be studied:
  Multiple sclerosis

Population studied

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

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The research question is to assess and characterize the long-term safety data from theuse of ocrelizumab in patients with MS (overall and by MS type).
• Outcomes:
  The primary objective is to estimate (overall and by MS type) the event rates of serious adverse events (SAEs), including malignancy and serious infections, following ocrelizumab treatment in patients with MS.
• Data analysis plan:
  Data will be analyzed every 6 months.The number of safety events and unadjusted incidence rates with 95% confidence intervals will be provided for each treatment group, ocrelizumab and other DMTs, for each data source. For malignancy and Progressive multifocal leukoencephalopathy (PML), an ever-exposed model will be applied that includes all person-time observed since the first drug dose in the study until censorship. For all other SAEs a time-on-drug approach will be used. For analyses of death, both approaches will be used.Comparison between ocrelizumab and other DMTs, at year 4, 6, 8, and end of the study, will be based on a Cox proportional-hazards regression model adjusted for important covariates and probability of treatment with ocrelizumab.