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 is 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 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.

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 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
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	Time Frame
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
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
Time from Cladribine Tablet Initiation to First Relapse	up to maximum 5 years after treatment initiation with Cladribine tablets
Percentage of Participants Who Discontinued Cladribine Tablets	From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
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
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
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
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

Collaborators and Investigators

• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Collaborators: 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

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 (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

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