Behavior and knowledge survey to assess the effectiveness of educational materials in patients treated with AUBAGIO® (teriflunomide) (cross-sectional survey)

Study type

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

  Other
• If ‘other’, further details on the scope of the study:
  Knowledge and behavior of treated patients
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

Study drug and medical condition

• Name of medicine:
  AUBAGIO

Population studied

• Short description of the study population:
  The population for this study will be a randomly generated sample of patients treated for Multiple Sclerosis (MS) with Aubagio. To have wide coverage of patients across the European Union (EU), the survey will be conducted in at least 5 countries of the EU. The registered patient population will be described in terms of age, year of first diagnosis and gender and compared in each participating country with the known MS population statistics.; Inclusion criteria; 1. Patient is being treated with Aubagio at study entry; 2. Patient supplies informed consent by ticking a box on the survey website; Exclusion criteria; 1. For Wave 2 only: patient completed the survey in Wave 1; 2. Patient has not been prescribed Aubagio.
• 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:
  Other
• Special population of interest, other:
  Multiple sclerosis patients
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  The objective of the study is to assess descriptively knowledge and behavior of treated patients about the items of the educational materials and thus the effectiveness of these materials and tools to ensure the safe use of Aubagio®.
• Outcomes:
  Knowledge is defined as awareness and understanding of important risk minimization information contained in the PIL and PC. Behavior is defined as report of appropriate risk minimization behavior. Appropriate risk minimization behavior is measured.
• Data analysis plan:
  Primary analysisThe analysis will be descriptive (e.g. frequency distributions for each item). The response on knowledge and behavior is considered satisfactory if participants provide >70% of correct answers.Secondary analysisThe analysis will be descriptive.1. Where knowledge or behavior is found to be <100% a more detailed analysis will be conducted (e.g. to identify specific areas where knowledge is low).2. Responses in subgroups compared to the rest of the sample. Subgroups to be analyzed include: country, childbearing potential, having read the RMP materials, time since prescription with Aubagio®.3. Comparison of age and time since diagnosis of the sample from each participating country with known MS population statistics in participating countries as a gauge of the representativeness of the sample.

Documents

Study results

Aubagio Patients Wave 1 and 2 combined report-Final