Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Registration Number
- NCT04997148
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief Summary
The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 116
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 One 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
Name Time Method Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death Relapse-free is defined as the time from the on-treatment period start date until first relapse or death as assessed by the investigator. Relapse-free rate, i.e., the survival rate using Kaplan Meier method, was summarized every year.
Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2) The number of participants who received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion were reported here.
Time From Cladribine Tablet Initiation to First Relapse up to maximum 5 years after treatment initiation with Cladribine tablets A qualifying relapse is defined as new, worsening or recurrent neurological symptoms attributed to Multiple Sclerosis (MS) that last for at least 24 hours without fever or infection, or adverse reaction to prescribed medication, preceded by a stable or improving neurological status of at least 30 days. Percentage of participants with qualified relapse-free status at week 24 were reported.
Number of Participants Who Discontinued Cladribine Tablets From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2) The number of participants who discontinued treatment with cladribine are reported here.
Number 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 he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis \[MS\]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Number 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 he EDSS is an ordinal clinical rating scale in half-point increments. It assesses the following eight functional systems, areas of the central nervous system that control bodily functions: Pyramidal (ability to walk), Cerebellar (coordination), Brain stem (speech and swallowing), Sensory (touch and pain), Bowel and bladder functions, Visual, Mental, Other (includes any other neurological findings due to Multiple Sclerosis \[MS\]). EDSS overall score ranging from 0 (normal) to 10 (death due to MS).
Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies 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 were reported.
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Trial Locations
- Locations (8)
University Hospitals Coventry and Warwickshire- Neurology
🇬🇧Coventry, United Kingdom
NHS Lanarkshire Health Board- Department of Neurology
🇬🇧Glasgow, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust
🇬🇧Leicester, United Kingdom
Barking Havering and Redbridge University Hospitals NHS Trust
🇬🇧London, United Kingdom
University College London UCL
🇬🇧London, United Kingdom
Nottingham City Hospital (2655)
🇬🇧Nottingham, United Kingdom
Salford Royal
🇬🇧Salford, United Kingdom
University Hospitals Coventry and Warwickshire- Neurology🇬🇧Coventry, United Kingdom