Clinical trial NCT04997148: Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)
Official title: Cladribine Tablets in Highly-active Relapsing Multiple Sclerosis - Real-World Effectiveness in UK Clinical Practice (CAMELOT-MS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Mavenclad ®
Cladribine
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Limited, UK
First posted: 2021-08-09
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with HDA-RRMS who initiated treatment with cladribine tablets.

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


Eligibility criteria: 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

Primary outcomes:
measure: Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets
timeFrame: 1 Year prior to date of Cladribine tablet initiation
measure: Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets
timeFrame: Year 1 after treatment initiation with Cladribine tablets
measure: Annualized Relapse Rate in the Year 2 After Treatment Initiation With Cladribine Tablets
timeFrame: Year 2 after treatment initiation with Cladribine tablets
measure: Annualized Relapse Rate in the Year 3 After Treatment Initiation With Cladribine Tablets
timeFrame: Year 3 after treatment initiation with Cladribine tablets
measure: Annualized Relapse Rate in the Year 4 After Treatment Initiation With Cladribine Tablets
timeFrame: Year 4 after treatment initiation with Cladribine tablets
measure: Annualized Relapse Rate in the Year 5 After Treatment Initiation With Cladribine Tablets
timeFrame: Year 5 after treatment initiation with Cladribine tablets
Secondary outcomes:
measure: Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment
timeFrame: Year 1, 2, 3, 4 and 5 after treatment initiation with Cladribine tablets until relapse or death
measure: Time From Cladribine Tablet Initiation to First Relapse
timeFrame: up to maximum 5 years after treatment initiation with Cladribine tablets
measure: Number of Participants Who Discontinued Cladribine Tablets
timeFrame: From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
measure: Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion
timeFrame: From Cladribine treatment initiation up to end of Cladribine treatment (assessed up end of Treatment Year 2)
measure: Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2
timeFrame: At Treatment Initiation and Start of Treatment Year 2
measure: 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
timeFrame: At 2 years after treatment initiation with Cladribine tablets
measure: Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies
timeFrame: At 2 years after treatment initiation with Cladribine tablets
Other outcomes:
Locations:
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire- Neurology
city: Glasgow
country: United Kingdom
facility: NHS Lanarkshire Health Board- Department of Neurology
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: Barking Havering and Redbridge University Hospitals NHS Trust
city: London
country: United Kingdom
facility: University College London UCL
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital (2655)
city: Salford
country: United Kingdom
facility: Salford Royal
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: