This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.
Study Type
OBSERVATIONAL
Enrollment
367
This is an observational study, participants who received cladribine tablets in routine clinical practice following the SmPC will be included.
UCL Saint Luc
Time to Discontinuation of Treatment with Cladribine tablets
Time frame: Up to 48 months
Percentage of participants Receiving Each of The Possible Number of Annual Treatment Courses with Cladribine Tablets
Time frame: Baseline, 12 months, 24 months, 36 months and 48 months
Cumulative Cladribine Dose
Time frame: Up to 48 months
Number of Relapses
Time frame: Baseline, 12 months, 24 months, 36 months and 48 months
Proportion of Severe Relapses
Time frame: Baseline, 12 months, 24 months, 36 months and 48 months
Percentage of Participants Free From Relapse
Time frame: Year 2 and Year 4
Time From Onset of Relapse to Recovery
Time frame: Up to Month 48
Annualized Relapse Rate (ARR)
Time frame: At Year 2 and Year 4
Percentage of Participants Free From Magnetic Resonance Imaging (MRI) Activity
Time frame: At Year 1, Year 2, Year 3 and Year 4
Percentage of Participants with Minimal MRI Activity (=< 2 New T2 Lesions)
Time frame: At Year 1, Year 2, Year 3 and Year 4
Timed 25-Foot Walk (T25FW) Score
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Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Percentage of Participants with an Increase and Decrease in Timed 25-Foot Walk (T25FW) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
9-Hole Peg Test (9HPT) Score
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Percentage of Participants with an Increase and Decrease in 9-Hole Peg Test (9HPT) Score of At Least 20% From Baseline at Year 1, 2, 3 and 4
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Progressed, Improved, or Stable Disability as Assessed by Expanded Disability Status Scale (EDSS) Confirmed Over 6 Months
Time frame: Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by T25FW Score
Time frame: Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Sustained Disability Progression, Improvement, or Stability Confirmed Over 6 Months as Assessed by 9HPT Score
Time frame: Year 1, Year 2, Year 3 and Year 4
Percentage of Participants With Minimal Evidence of Disease Activity (MEDA)
Time frame: Year 2 and Year 4
Percentage of Participants With No Evidence of Disease Activity (NEDA-3)
Time frame: Year 2 and Year 4
Multiple Sclerosis Impact Scale (MSIS-29) Physical Domain Score, Psychological Domain Score and Total Score
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
EuroQol 5-Dimensions (EQ-5D-5L) Score
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Global Satisfaction, Effectiveness, Side Effects, and Convenience Domain Scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4
Treatment Cost of Disease-Modifying Treatment (DMTs)
Time frame: Up to 48 months
EuroQol Visual Analog Scale (EQ-VAS) Score
Time frame: Baseline, Year 1, Year 2, Year 3 and Year 4