Prospective Observational Study Aimed at Evaluating Treatment Satisfaction and Effectiveness in Patients with Relapsing Multiple Sclerosis Starting CLADRibinE TAbLets (CLADREAL)

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

• Medicinal product name:
  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

  Relapsing 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:
  391

Study design details

• Main study objective:
  To assess the change in patient’s global treatment satisfaction at 24 months after cladribine tablet treatment initiation among patients with RMS switching from 1st-line DMT and patients with RMS switching from 2nd-line DMT.
• Outcomes:
  - Change in the global satisfaction domain of TSQM V1.4 at Visit 5 (Month 24) from Baseline (Visit 0) in patients with RMS switching from 1st-line DMT and patients with RMS switching from 2nd-line DMT. ; - Change in TSQM domains score.; - Time from 1st dose of cladribine tablets to 1st relapse ARR over 1st and 2nd year after cladribine initiation.; - Proportion of patients with sustained disability progression improvement, or stability confirmed over 6 months as assessed by EDSS Proportion of patients free from lesions Number of CUA lesions.; - Change in EuroQoL-5D-5L, PSQI, PROMIS SF-15 and SF-8 scores.
• Data analysis plan:
  All patients enrolled in study who received at least 1 dose of cladribine tablets will be included in analysis. Primary outcome will be analyzed using descriptive statistics for continuous variables. CIs will be provided.Secondary outcomes of TSQM V1.4 will be analyzed with descriptive statistics, including Group A, B,C.In addition, time from cladribine tablet initiation to 1st relapse will be described using Kaplan-Meier method and ARR in 1st year and 2nd year after cladribine tablet initiation will be reported,accompanied by respective 95% CI. Furthermore, proportion of patients with disability progression, stability or improvement as assessed by EDSS, proportion of patients free from T1 Gd+ lesions, and proportion of patients free from new/enlarging T2 will be summarized at Visit 3 and Visit 5 using descriptive statistics. For other PRO scores (EQ-5D-5L scores, PSQI,Brief IPQ scores,PROMIS SF-15 and PROMIS SF-8) at Visit 1, 3, and 5, descriptive statistics will be provided