Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Study Overview
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Brief Summary
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The main aim is to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) [DMF]) to treatment with Cladribine tablets in routine clinical practice.

Official Title
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Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Drug: Cladribine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants with confirmed diagnosis of RRMS diagnosed by the treating physician according to applicable clinical practice guidelines -(currently McDonald 2017 criteria), with high disease activity Participants should have been treated with the same first-line DMD (Interferons, Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year prior to switch to Cladribine tablets and should have been prescribed Cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. Any washout period and/or washout methods required before switching (such as elimination of Teriflunomide) must have been conducted, according to the decision of the treating physician Required history data should be available: Multiple Sclerosis (MS) data for the 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior DMDs) Fulfilment of the criteria for treatment with Cladribine tablets per standard of care in accordance with the local Summary of Product Characteristics (SmPC) Exclusion Criteria: Contraindications to use of cladribine tablets according to the SmPC Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study Participants that have received Cladribine in the past Concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol

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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cladribine<br> | Drug: Cladribine<br>* No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.<br>* Other names: MAVENCLAD ®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period Before the End of Study Follow-Up |  | 12-months pre-baseline up to Year 2 post-baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period After the Start of Cladribine |  | 12-months pre-baseline up to Year 1 post-baseline | 
| Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS) |  | Up to 2 years | 
| Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW) |  | Up to 2 years | 
| Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT) |  | Up to 2 years | 
| Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS) |  | Up to 2 years | 
| Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW) |  | Up to 2 years | 
| Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT) |  | Up to 2 years | 
| Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Up to 2 years | 
| Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29) |  | Baseline, Months 12 and 24 | 
| Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale |  | Months 6, 12, 18 and 24 | 
| Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire |  | Baseline, Months 12 and 24 | 
| Percentage of Participants With Treatment Adherence |  | Up to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Cladribine, MAVENCLAD ®