ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis
Status:
Not yet recruiting
Trial end date:
2024-07-04
Target enrollment:
Participant gender:
Summary
MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS)
affecting more than 120,000 people in the UK.and 2.5 million people worldwide.
Without disease modifying treatment (DMT),the majority of people with MS (pwMS) will develop
significant disability within 10 years of onset, and 50% will require wheelchair assistance
within 20 years. convenient, highly effective and CNS penetrant DMT for patients with
relapsing multiple sclerosis (pwRMS) administered in short (8-10 days/year over 2 years)
treatment courses.
It effectively depletes B cells, particularly Memory B cells, a likely key mechanism of
disease control in MS. Cladribine is the investigational product in this study as it not
currently used to treat patients with an EDSS of 6.5 - 8.5. This is a multi-centre,
randomised double-blind placebo-controlled phase IIb to test cladribine tablets (MAVENCLAD®)
(3.5mg/kg over 24 months) for safety, efficacy, and cost effectiveness, and to advance
mechanistic understanding of its action in people with advanced MS (pwAMS).
Phase:
Phase 2/Phase 3
Details
Lead Sponsor:
Queen Mary University of London
Collaborators:
The Leeds Teaching Hospitals NHS Trust University College, London University of Edinburgh University of Leeds University of Plymouth