Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)

Study Overview
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Brief Summary
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The main purpose of this study is to investigate the effectiveness of cladribine tablets in a UK real-world setting.

Official Title
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Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)

Conditions
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Relapsing-Remitting Multiple Sclerosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Physician diagnosis of HDA-RRMS as defined by clinical or radiological features Treatment initiation with cladribine tablet monotherapy on or after 22 August 2017 and at least 3 years before enrolment Completion of Year 1 treatment of cladribine tablets (Week 1 and Week 2 treatment, per recommended dose in Year 1: 1.75 milligrams per kilogram [mg/kg] body weight, cumulatively) Exclusion Criteria: Received cladribine tablet treatment within an interventional clinical trial during the study period Received treatment with any investigational therapy for RRMS in the 6 months prior to cladribine tablet treatment initiation

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>No intervention will be administered as a part of this study. Participants with Highly-active Disease Relapsing-remitting Multiple Sclerosis (HDA-RRMS), who completed at least Year 1 of treatment with cladribine tablets in routine clinical practice will be enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in the year prior to the date of Cladribine tablet initiation. | 1 Year prior to date of Cladribine tablet initiation | 
| Annualized Relapse Rate in the Year 1 After Treatment Initiation With Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 1 after treatment initiation with Cladribine tablets. | Year 1 after treatment initiation with Cladribine tablets | 
| Annualized Relapse Rate in the Year 2 After Treatment Initiation with Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 2 after treatment initiation with Cladribine tablets. | Year 2 after treatment initiation with Cladribine tablets | 
| Annualized Relapse Rate in the Year 3 After Treatment Initiation with Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 3 after treatment initiation with Cladribine tablets. | Year 3 after treatment initiation with Cladribine tablets | 
| Annualized Relapse Rate in the Year 4 After Treatment Initiation with Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Years 4 after treatment initiation with Cladribine tablets. | Year 4 after treatment initiation with Cladribine tablets | 
| Annualized Relapse Rate in the Year 5 After Treatment Initiation with Cladribine Tablets | The annualized relapse rate for a participant is defined here as the number of clinician's confirmed relapses that occurred in Year 5 after treatment initiation with Cladribine tablets. | Year 5 after treatment initiation with Cladribine tablets | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Who Remain Relapse-Free in Each Year after Initiation of Cladribine Tablet Treatment |  | Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets | 
| Percentage of Participants Who Remain Relapse-free up to 5 years After the Initation of Caldribine Tablets |  | Up to 5 years after the initation of Cladribine tablets | 
| Time from Cladribine Tablet Initiation to First Relapse |  | up to maximum 5 years after treatment initiation with Cladribine tablets | 
| Percentage of Participants Who Discontinued Cladribine Tablets |  | From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2) | 
| Percentage of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion |  | up to 5 years after treatment initiation with Cladribine tablets | 
| Percentage of Participants with Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2 |  | At Treatment Initiation and Start of Treatment Year 2 | 
| Percentage of Participants with Disability Progression Confirmed over 6 Months, Assessed by Expanded Disease Severity Scale (EDSS) at 2 Years after Cladribine Tablet Treatment Initiation |  | At 2 years after treatment initiation with Cladribine tablets | 
| Number of Participants with Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies |  | up to maximum 5 years after treatment initiation with Cladribine tablets | 

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