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 topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  OCREVUS
• Study drug International non-proprietary name (INN) or common name:
  OCRELIZUMAB
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AG08) ocrelizumab

  ocrelizumab
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  Patients with MS from the post-marketing setting who have initiated treatment with ocrelizumab or one of the 6 approved MS DMTs specified in the protocol no more than 30 days prior to study entry will participate in this study.; Patients must meet the following criteria for study entry:; • Signed informed consent; • Have a diagnosis of MS; • Aged 18 years or older; • Newly treated with ocrelizumab (within 30 days before baseline visit [study entry]) according to the local label irrespective of the reason for starting ocrelizumab (ocrelizumab cohort), or; • Newly treated with one of the following 6 approved MS DMTs: alemtuzumab, cladribine, dimethyl fumarate, fingolimod, natalizumab, or teriflunomide (within 30 days before baseline visit [study entry]) according to the local label irrespective of the reason for starting a new MS DMT (internal comparator cohort); ; Patients who meet the following criteria will be excluded from study entry:; • Patients who have any prior exposure to rituximab or to any anti CD-20 therapy for MS; • Active participation in interventional clinical trials for MS; • Patients who have received ocrelizumab more than 30 days before baseline visit (study entry)
• 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:
  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 outcome is: ; -Incidence rate of breast cancer and all malignancies following the first ocrelizumab treatment among patients with MS ; The secondary outcomes include: ; -Mortality rate of breast cancer and all malignancies following the first ocrelizumab treatment among patients with MS; -Compare the observed incidence and mortality rates of breast cancer and all malignancies between ocrelizumab-exposed MS patients and MS patients newly treated with one of the 6 approved MS disease modifying therapies (DMTs) specified in the protocol (alemtuzumab, cladribine, dimethyl fumarate, fingolimod, natalizumab, or teriflunomide) as well as general populations; -Event rate of all serious adverse events (SAEs) in the ocrelizumab-treated patients with MS
• 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, study withdrawal, 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 adjusted for confounding factors. In addition, comparisons include the MSBase Registry and the SEER Program (external comparators).