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

  • Adult and elderly population (≥18 years)
    • Adults (18 to < 65 years)
      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 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.