Survey to Assess the Effectiveness of Ponvory® Educational Materials for Additional Risk Minimization Measures in the European Union

Study type

• Study topic:
  Human medicinal product
• Study type:
  Not applicable
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

Study drug and medical condition

• Name of medicine:
  PONVORY
• Study drug International non-proprietary name (INN) or common name:
  PONESIMOD
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA50) ponesimod

  ponesimod

Population studied

• 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)
• Estimated number of subjects:
  355

Study design details

• Main study objective:
  Knowledge and understanding for the management of Ponvory risks
• Outcomes:
  Knowledge and understanding for the management of Ponvory risks, receipt and awareness of the educational materials.
• Data analysis plan:
  The third-party vendor will perform rigorous ‘real-time’ checks to ensure that the data collected are valid and of a high quality. Inbuilt quality control within the surveys will minimize the opportunity for missing data. Data analysis will be performed by the third-party vendor. A minimum total score of ≥80% of correct responses on all survey questions will be considered indicative of satisfactory effectiveness. The threshold of success refers to the proportion of correct responses at each survey question. Achieving ≥80% correct responses to each question represents a sizeable majority. Summary results for the overall response rate and 95% CI will be presented separately for HCPs and patients/caregivers.