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

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

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

Study Overview

• Status: Completed
• Conditions: Relapsing-Remitting Multiple Sclerosis

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• United Kingdom
  • Coventry, United Kingdom
    • University Hospitals Coventry and Warwickshire- Neurology
  • Glasgow, United Kingdom
    • Queen Elizabeth University Hospital
  • Glasgow, United Kingdom
    • NHS Lanarkshire Health Board- Department of Neurology
  • Leicester, United Kingdom
    • University Hospitals Of Leicester Nhs Trust
  • London, United Kingdom
    • Barking Havering and Redbridge University Hospitals NHS Trust
  • London, United Kingdom
    • University College London UCL
  • Nottingham, United Kingdom
    • Nottingham City Hospital (2655)
  • Salford, United Kingdom
    • Salford Royal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with HDA-RRMS who initiated treatment with cladribine tablets.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cladribine; No intervention was 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 were enrolled into this study and assessed up to maximum 5 years after cladribine tablets initiation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Annualized Relapse Rate in the Year One 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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment	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.	Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death
Time From Cladribine Tablet Initiation to First Relapse	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.	up to maximum 5 years after treatment initiation with Cladribine tablets
Number of Participants Who Discontinued Cladribine Tablets	The number of participants who discontinued treatment with cladribine are reported here.	From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion	The number of participants who received Subsequent Disease-modifying Therapies (DMTs) after Cladribine Tablets Discontinuation/Treatment Completion were reported here.	From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) 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).	At Treatment Initiation and Start of Treatment Year 2
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	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).	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	Number of Participants with Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies were reported.	At 2 years after treatment initiation with Cladribine tablets

Collaborators and Investigators

• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Collaborators: Merck Serono Limited, UK
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2021
• Primary Completion (Actual): September 14, 2023
• Study Completion (Actual): September 14, 2023

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 13, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Multiple Sclerosis; Cladribine; Mavenclad ®
• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: MS700568_0150