An observational, multicenter, prospective, phase IV study evaluating cladribine tablets’ effects on PROs and their correlation with clinical and biometric parameters using Health Technology in subjects with highly-active RMS at their first switch (CLADFIT-MS)

Study type

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

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Name of medicine:
  MAVENCLAD
• Study drug International non-proprietary name (INN) or common name:
  CLADRIBINE
• Anatomical Therapeutic Chemical (ATC) code:
  (L04AA40) cladribine

  cladribine
• Medical condition to be studied:
  Multiple sclerosis

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:
  215

Study design details

• Main study objective:
  The aim of the study will be to evaluate the effect of cladribine tablets on patient-reported outcomes (PROs) and their correlation to disability in subjects with highly-active MS (multiple sclerosis) who started their first switch from a disease-modifying drug (DMD) to cladribine tablets as their first second-line treatment in clinical practice.
• Outcomes:
  - To evaluate changes in self-assessed physical impact of highly-active MS in daily life after the switch to cladribine tablets, ; - Changes in self-assessed psychological impact, general health, cognitive functions, anxiety and depression, employment status after switch ; - Relationship between changes and evaluations from wearable trackers ; - Self-assessment and correlation with evaluations from wearable trackers ; - Annualized relapse rate Real-world pharmacoeconomic data ; - Safety in real-world clinical practice
• Data analysis plan:
  No formal statistical hypothesis will be tested. ; Quantitative (continuous) variables will be summarized using descriptive statistics, i.e. number of subjects with non-missing value, no of subjects with missing value, mean, SD, median, min and max, and first and third quartile. ; Qualitative (categorical) variables will be displayed as frequency counts and percentages (n,%). Due to longitudinal nature of data, some outcomes data may be missing. ; Patterns and degrees of missingness will be summarized. ; As primary and secondary outcomes are based on PRO data, this will include the no of items missing for each scale and percentage of computable scale scores. ; Descriptive statistics on outcome data may be used to identify potential data outliers. If CIs are to be calculated, these will be 2-sided with confidence probability of 95%. ; For continuous data, CIs for mean will be calculated assuming a normal distribution of data. CIs for binary outcomes will be presented using Clopper-Pearson method