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

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04997148
Collaborator
Merck Serono Limited, an affiliate of Merck KGaA, Darmstadt, Germany (Other)
200
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24
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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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)
    Actual Study Start Date :
    Aug 11, 2021
    Anticipated Primary Completion Date :
    Aug 10, 2023
    Anticipated Study Completion Date :
    Aug 10, 2023

    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

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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

    1. 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]

    2. 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]

    3. Time from Cladribine Tablet Initiation to First Relapse [up to maximum 5 years after treatment initiation with Cladribine tablets]

    4. Percentage of Participants Who Discontinued Cladribine Tablets [From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)]

    5. 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]

    6. 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]

    7. 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]

    8. 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

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT04997148
    Other Study ID Numbers:
    • MS700568_0150
    First Posted:
    Aug 9, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2022