Malignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study) (MALBEC-f)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study

Non-interventional study

• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Secondary data collection
• Non-interventional study design:
  Cohort

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  INTERFERON BETA-1A

  INTERFERON BETA-1B

  GLATIRAMER ACETATE

  PEGINTERFERON BETA-1A

  DACLIZUMAB

  TERIFLUNOMIDE

  FINGOLIMOD HYDROCHLORIDE

  DIMETHYL FUMARATE

  ALEMTUZUMAB

  MITOXANTRONE

  NATALIZUMAB

  METHOTREXATE

  CYCLOPHOSPHAMIDE

  MYCOPHENOLIC ACID

  AZATHIOPRINE

  RITUXIMAB
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  Multiple sclerosis patients
• 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)
• Special population of interest:
  Immunocompromised
• Estimated number of subjects:
  632

Study design details

• Main study objective:
  To estimate the incidence of malignancies stratified by age and gender:- in the MS cohort compared to a sample of non-MS patients from the general population,- in untreated patients of the MS cohort,- in newly treated patients with disease modifying drugs (DMD) according to the DMD group,To characterize the association between DMD treatment exposure and any occurrence of malignacies.
• Outcomes:
  Occurrence of any malignancies (including/excluding Non-melanoma skin cancer) :- Overall- Per individual malignancy type.
• Data analysis plan:
  The statistical analysis will be performed using the SAS software (latest current version), following a detailed statistical analysis plan.Descriptive analyses will be conducted on the MS population, the untreated MS population and the MS population newly treated with a DMD. Crude and adjusted incidence rates of malignancy will also be calculated stratified on age and gender, in the MS, the untreated MS and the MS newly treated populations. The malignancy incidence estimated in the MS cohort will be then compared to the malignancy incidence estimated after age- and sex-standardization in a sample of non-MS patients from the general population. In the MS newly treated population, the association between DMD and risk of malignancy will be assessed with a time varying cox model.