Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)
Study Details
Study Description
Brief Summary
The main purpose of this study is to investigate the effectiveness of cladribine tablets in a UK real-world setting.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cladribine 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. |
Outcome Measures
Primary Outcome Measures
- Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets [1 Year prior to date of Cladribine tablet initiation]
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.
- Annualized Relapse Rate in the Year 1 After Treatment Initiation With Cladribine Tablets [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.
- Annualized Relapse Rate in the Year 2 After Treatment Initiation with Cladribine Tablets [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.
- Annualized Relapse Rate in the Year 3 After Treatment Initiation with Cladribine Tablets [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.
- Annualized Relapse Rate in the Year 4 After Treatment Initiation with Cladribine Tablets [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.
- Annualized Relapse Rate in the Year 5 After Treatment Initiation with Cladribine Tablets [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.
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Physician diagnosis of HDA-RRMS as defined by clinical or radiological features
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Treatment initiation with cladribine tablet monotherapy on or after 22 August 2017 and at least 3 years before enrolment
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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:
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Received cladribine tablet treatment within an interventional clinical trial during the study period
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Received treatment with any investigational therapy for RRMS in the 6 months prior to cladribine tablet treatment initiation
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals Coventry and Warwickshire- Neurology | Coventry | United Kingdom | ||
| 2 | NHS Lanarkshire Health Board- Department of Neurology | Glasgow | United Kingdom | ||
| 3 | Queen Elizabeth University Hospital | Glasgow | United Kingdom | ||
| 4 | University Hospitals of Leicester NHS Trust | Leicester | United Kingdom | ||
| 5 | Barking Havering and Redbridge University Hospitals NHS Trust | London | United Kingdom | ||
| 6 | University College London UCL | London | United Kingdom | ||
| 7 | Nottingham City Hospital (2655) | Nottingham | United Kingdom | ||
| 8 | Salford Royal | Salford | United Kingdom |
Sponsors and Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Merck Serono Limited, an affiliate of Merck KGaA, Darmstadt, Germany
Investigators
- Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MS700568_0150