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 (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

5133
Study design details

Main study objective

The research question is to assess and characterize the incidence and mortality rates of breast cancer, all malignancies, and the long-term safety regarding serious adverse events (SAEs) among patients with multiple sclerosis (MS) newly exposed to ocrelizumab under routine clinical care.

Outcomes

The primary outcomes are: - Breast cancer - All malignancies, In addition to the primary outcomes, the secondary outcomes include: - Mortality due to breast cancer - Mortality due to all malignancies - All Serious Adverse Events

Data analysis plan

Incidence rates will be calculated as the number of first (i.e. incident) events divided by the total patient-years (PY) at risk. PY at risk will be calculated from the first dose until the event, death, loss to follow-up, or the end of the study, whichever occurs first. For breast cancer and malignancies an ever-exposed model will be used, irrespective of the exposure duration. For all other SAEs and AESIs, a time-on-drug approach will be used where PYs will be calculated from first dose up to 6 months after the last administration of ocrelizumab. The incidence and mortality rates of breast cancer and all malignancies will be compared with a cohort of patients treated with approved MS DMTs other than ocrelizumab (internal comparator). Comparisons will use time to event regression adjused for confounding factors. In addition, comparisons include the MSBase Registry and the SEER Program (external comparators).