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- W4290829857 abstract "Background Disease-modifying treatments (DMT) have transformed the management of people with MS. However, those with an EDSS>6.5 (pwAMS) are considered not suitable for DMT due to (i) a focus on ambulation as outcome measure, (ii) the assumption that in pwAMS, inflammation plays no role, and (iii) a disregard for potentially length-dependent neuro-axonal damage. Cladribine tablets (Mavenclad®) is an effective, convenient, relatively safe DMT licensed for people with highly-active relapsing MS. Cladrib- ine depletes B (less so T) cell subsets, particularly memory B cells, putatively key for disease control in MS. Aims To test efficacy, safety and cost-effectiveness of cladribine tablets in pwAMS (EDSS 6.5-8.5), expand mechanistic understanding of cladribine and provide evidence for NHS adoption. Methods Randomised, double-blind, placebo-controlled phase IIb trial. Primary outcome measure, 9-hole peg test speed at 104 weeks vs baseline. Sample size calculations indicated n=200 required to detect 15% treatment effect in 9HPT peg-speed with 90% power at 5% significance and 20% drop-out. Results Nine/20 trial sites currently open for recruitment. Five participants already enrolled. Full recruit- ment predicted in Q1/2023. Conclusions ChariotMS is the first DMT-trial focussing on pwAMS. If successful, ChariotMS could expand the DMT landscape to include pwAMS, and provide a platform for add-on therapies." @default.
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- W4290829857 date "2022-08-12" @default.
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- W4290829857 title "153 ChariotMS – cladribine to halt deterioration in people with advanced multiple sclerosis (pwAMS)" @default.
- W4290829857 doi "https://doi.org/10.1136/jnnp-2022-abn2.197" @default.
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