N/A
Completed N=116
Effectiveness of Cladribine Tablets in Participants With Highly-active Relapsing Multiple Sclerosis (CAMELOT-MS)
Source: ClinicalTrials.gov NCT04997148 ↗Enrolled (actual)
116
Serious AEs
0.9%
Results posted
Dec 2024
Primary outcomePrimary: Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets — 0.595 Relapse per year
Summary
The main purpose of this study was to investigate the effectiveness of cladribine tablets in a UK real-world setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Annualized Relapse Rate in the Year Prior to Treatment Initiation With Cladribine Tablets |
0.595 | — |
| PRIMARY Annualized Relapse Rate in the Year One After Treatment Initiation With Cladribine Tablets |
0.101 | — |
| PRIMARY Annualized Relapse Rate in the Year 2 After Treatment Initiation With Cladribine Tablets |
0.052 | — |
| PRIMARY Annualized Relapse Rate in the Year 3 After Treatment Initiation With Cladribine Tablets |
0.086 | — |
| PRIMARY Annualized Relapse Rate in the Year 4 After Treatment Initiation With Cladribine Tablets |
0.060 | — |
| PRIMARY Annualized Relapse Rate in the Year 5 After Treatment Initiation With Cladribine Tablets |
0.063 | — |
| SECONDARY Relapse-Free Rate in Each Year After Initiation of Cladribine Tablet Treatment |
0.92; 0.85; 0.81; 0.78; 0.75 | — |
| SECONDARY Time From Cladribine Tablet Initiation to First Relapse |
NA | — |
| SECONDARY Number of Participants Who Discontinued Cladribine Tablets |
4 | — |
| SECONDARY Number of Participants Who Received Subsequent Disease-modifying Therapies (DMTs) After Cladribine Tablets Discontinuation/Treatment Completion |
19 | — |
| SECONDARY Number of Participants With Disability Progression Assessed by Expanded Disease Severity Scale (EDSS) at Treatment Initiation and Start of Treatment Year 2 |
— | — |
| SECONDARY 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 |
— | — |
| SECONDARY Number of Participants With Grade 3 Lymphopenia, Grade 4 Lymphopenia, Herpes Infections, Serious Infections, Opportunistic Infections and Malignancies |
47; 0; 6; 8; 1 | — |
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
Data sourced from ClinicalTrials.gov (NCT04997148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.