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Completed

NCT Number: NCT04997148

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospitals Coventry and Warwickshire- Neurology, Coventry, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets

    Time frame: 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 One After Treatment Initiation With Cladribine Tablets

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment

    Time frame: 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.

  2. Time From Cladribine Tablet Initiation to First Relapse

    Time frame: 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.

  3. Number of Participants Who Discontinued Cladribine Tablets

    Time frame: 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.

  4. Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion

    Time frame: 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.

  5. Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2

    Time frame: 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).

  6. 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

    Time frame: 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).

  7. Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Industry

Collaborators

  • Merck Serono Limited, UK

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 9, 2021
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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