Prescriber survey to evaluate the awareness to risk minimisation measures for mitoxantrone-containing medicinal products in the treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  MITOXANTRONE
• Medical condition to be studied:
  Relapsing multiple sclerosis

Population studied

• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)
• Estimated number of subjects:
  98

Study design details

• Main study objective:
  The objective of this study is to evaluate the awareness of the treating (or intending to treat) neurologists on risk minimization measures (RMMs) for patients with highly active relapsing MS associated with rapidly evolving disability, to minimize the cardiotoxic and malignancy risk associated with the use of mitoxantrone detailed in the EMs.
• Data analysis plan:
  Continuous variables will be described by their number (of valid cases), mean, standard deviation, and median, Q1, Q3, minimum and maximum. Categorical variables will be described as the total number and relative percentage per category. CI of 95% will be evaluated, when relevant. Results will be weighted based on the real number of neurologists in each country as mentioned in OneKey lists. The proportions of correct and appropriate answers to selected questions asked in the questionnaire will be expressed among neurologists who provided answers to those questions. The endpoint will be assessed overall, by country and by neurologists. The neurologists’ participation in the survey will be examined in several ways: 1) response rate, 2) refusal rate, 3) contact rate, 4) cooperation rate. The assessment of the success of the RMMs will be considered for each of the three outcomes awareness, self-declared behavior, and knowledge.