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NCT04997148 Clinical Trial

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

Relapsing-Remitting Multiple Sclerosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04997148
Other study ID # MS700568_0150
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 11, 2021
Est. completion date September 14, 2023

Study information
Verified date December 2023
Source Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 116
Est. completion date September 14, 2023
Est. primary completion date September 14, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom 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

Sponsors (2)
Lead Sponsor Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany Merck Serono Limited, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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 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
Secondary 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
Secondary Time from Cladribine Tablet Initiation to First Relapse up to maximum 5 years after treatment initiation with Cladribine tablets
Secondary Percentage of Participants Who Discontinued Cladribine Tablets From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
Secondary 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
Secondary 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
Secondary 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
Secondary 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
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