A prospective, observational, UK study to describe patient reported quality of life in relapsing remitting multiple sclerosis patients treated with Aubagio® (teriflunomide) 14 mg in a routine clinical practice. (TeriQoL)

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Patient reported quality of life

Study drug and medical condition

• Medical condition to be studied:
  Relapsing-remitting multiple sclerosis

Population studied

• 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)
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  The primary objective of this study is to describe the change in HRQoL at 2 years in patients commencing treatment with Aubagio® in routine clinical practice for RMMS.
• Outcomes:
  The primary study endpoint is the change in HRQL at month 24 compared with baseline, as measured by the MSIS-29. the secondary variables areClinical outcomesDescribe the number of relapses during the two year periodPROsFatigueAnxiety and depressionCognitionSexual DysfunctionDisease progressionTreatment satisfactiontreatment adherenceHealth economics outcomesAssessed by number of scheduled and unscheduled healthcare professional encounters and emergency visits and productivity loss
• Data analysis plan:
  The analysis population will include all enrolled patients who received at least one dose of study medication. All study analysis, including safety analysis, will be performed in this population. All recorded clinical observations will be analysed using descriptive statistics.Data will be summarized into counts of non-missing data, mean, standard deviation, and minimum, maximum, median, Q1, and Q3 for quantitative variables and frequency and percent for categorical data. The 95% confidence interval will be provided when necessary.Subgroup analysis may be conducted as deemed necessary.The frequency and percentage of patients experiencing AEs, SAEs, and AESIs will be reported. The number and proportion of not serious and serious adverse events will be calculated. All non-serious and serious adverse events and the related information will be presented in individual data listing tables as well.