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

NCT04997148 | Completed Results

• 1 other identifier: MS700568_0150
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Relapsing-Remitting Multiple Sclerosis

Keywords

Multiple Sclerosis; Mavenclad ®; Cladribine

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

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

  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

  up to maximum 5 years after treatment initiation with Cladribine tablets

• Number of Participants Who Discontinued Cladribine Tablets

  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

  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

  At Treatment Initiation and Start of Treatment Year 2

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead
• Merck Serono Limited, UK: collaborator

Study Sites (8)

University Hospitals Coventry and Warwickshire- Neurology

Coventry, United Kingdom

Location

NHS Lanarkshire Health Board- Department of Neurology

Glasgow, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Location

Barking Havering and Redbridge University Hospitals NHS Trust

London, United Kingdom

Location

University College London UCL

London, United Kingdom

Location

Nottingham City Hospital (2655)

Nottingham, United Kingdom

Location

Salford Royal

Salford, United Kingdom

Location

Related Links

• Trial Awareness and Transparency website
• Medical Information Location Map - Med Info Contacts

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

Potential limitations include the retrospective study design, and that data was limited by control over patient assessment as patient monitoring and diagnostics were per standard of care.

Results Point of Contact

• Title: Communication Center
• Organization: Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

service@emdgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 9, 2021
• Study Start: August 11, 2021
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: December 18, 2024
• Results First Posted: December 18, 2024

Record last verified: 2024-12

Locations

GB (8)