Cognition and HRQoL in Adults With Highly-active RMS in Year 3 and 4 After Initial Mavenclad® Dose (CLARIFY MS Extension)

Study Overview
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Brief Summary
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The purpose of the study is the evaluation of the effect of a treatment for highly-active relapsing multiple sclerosis (RMS). This is the extension study to CLARIFY MS (NCT03369665), to assess cognitive impairment and health related quality of life (HRQoL) in participants with highly active RMS, at 4 years after initial dose of Mavenclad® tablets.

Official Title
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A 2-year Follow-up Study to Assess Cognition and Health-related Quality of Life in Participants With Highly-active Relapsing Multiple Sclerosis, Having Participated in the CLARIFY MS Trial (CLARIFY MS Extension)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Mavenclad®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have at least CLARIFY MS Baseline data on Symbol Digit Modalities Test (SDMT) Received at least a single dose of cladribine tablets in the CLARIFY MS study Completed the Final Study Visit (M24) of the CLARIFY MS study Capable of giving signed informed consent, as indicated in protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol Exclusion Criteria: Participant is considered by the Investigator and Sponsor, for any reason, to be an unsuitable candidate for the study Participation in other studies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mavenclad®<br> | Drug: Mavenclad®<br>* This low interventional extension study involves the follow up of participants in the parent study. The participants will be followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With No or Minimal Decline in Cognitive Function, Defined As an Improved or Stable Symbol Digit Modalities Test (SDMT) Score or a Decline of 4 points or Less in the SDMT Score, at 4 Years |  | Up to 4 years after initial dose of Mavenclad® in parent study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Scores at 4 Years |  | Baseline (baseline of parent study), 4 years after initial dose of Mavenclad® in parent study | 
| Change From Month 24 in Health Related Quality of Life (HRQoL) as Measured by Multiple Sclerosis Quality of Life 54 Questionnaire (MSQoL-54) Physical and Mental Health Scores at 4 Years |  | Month 24 after initial dose of Mavenclad® in parent study, 4 years after initial dose of Mavenclad® in parent study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple sclerosis, Health related quality of life, Mavenclad®, Relapsing Multiple Sclerosis, Cladribine, Cognitive impairment cognition, Fatigue