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
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Relapsing-Remitting Multiple Sclerosis
• Sclerosis

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

External Links

•   Trial Awareness and Transparency website