A prospective, open-label, multicenter, single-arm observational registry to describe adherence in relapsing remitting multiple sclerosis patients being prescribed teriflunomide (Aubagio®) in Belgium in routine clinical practice. (AUBADHE)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, open-label, multicenter, single-arm observational registry

Study drug and medical condition

• Name of medicine:
  AUBAGIO
• Medical condition to be studied:
  Multiple sclerosis

Population studied

• Short description of the study population:
  Adult patients aged 18 years or older diagnosed with relapsing remitting multiple sclerosis receiving treatment with teriflunomide (Aubagio) included from 1st; of November 2019 and were followed-up to 12 months or treatment termination, whichever came first under the routine clinical practice. ; Inclusion criteria: ; • Aubagio was prescribed to the patient independently from the decision to include the patient in the registry; • Patient was prescribed Aubagio according to reimbursement criteria in Belgium:; a) Adult patients (>18 years old); b) Patients suffering from RRMS diagnosed using the most recent version of the McDonald criteria; c) Expanded Disability Status Scale (EDSS) score ≤ 6.5; • Patient understood and signed informed consent form; • Patient did not have the first intake of Aubagio at the time of inclusion visit yet; ; Exclusion criteria: ; • Patient presenting a contraindication according to the local label.; • Prior treatment with Aubagio; • Participation to an Aubagio Patient Support Program (PSP).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with multiple sclerosis
• Estimated number of subjects:
  120

Study design details

• Main study objective:
  To describe adherence in terms of persistence and continuation rate during the first 18 months in patients who take Aubagio® in a real life setting.
• Outcomes:
  To describe adherence in terms of: - Persistence during the first 18 months in patients who take Aubagio® in a real life setting - Continuation rate in patients taking Aubagio® at 18 months based on refill data and and modified BAASIS questionnaire, Secondary endpoints will describe adherence in terms of initiation, implementation and persistence at different time points according to the prescription renewal dates and/or the modified BAASIS questionnaire. Drivers and barriers to adherence will be evaluated, as well as disease-related factors, such as fatigue, depression and cognition
• Data analysis plan:
  The statistical analysis will be performed using SAS v9.4. statistical software. The approach to the statistical analyses in this project will be descriptive in nature. Continuous data will be described by their mean, standard deviation, median, minimum and maximum. All summaries will be presented on all available data. Categorical data will be described by the number and percentage of subjects in each category. Missing observations will be presented in tables as a separate category. The calculation of proportions will not include the missing category. In addition to descriptive statistics for the primary, secondary, and exploratory outcome variables, subgroup evaluations may be performed. Subgroups of interest may be defined by baseline demographics, treatment experience, site characteristics and levels of fatigue and/or cognition and/or depression. Inferential statistics will also be used to potentially compare the subgroups. To be continued.