An Observational Study of Ocrelizumab Treated Patients with Multiple Sclerosis to Determine the Incidence and Mortality Rates of Breast Cancer and All Malignancies (VERISMO 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 (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).