ChariotMS - Cladribine for people with advanced multiple sclerosis

• Research type

  Research Study

• Full title

  ChariotMS – A national (UK), multi-centre, randomised, double-blind, placebo-controlled (1:1) phase IIb efficacy trial with cost-utility analysis of cladribine tablets (3.5mg/kg over two years) in people with advanced multiple sclerosis (EDSS 6.5-8.5). Is cladribine superior to placebo in protecting upper limb function?

• IRAS ID

  258909

• Contact name

  Klaus Schmierer

• Contact email

  k.schmierer@qmul.ac.uk

• Sponsor organisation

  Queen Mary University of London

• Eudract number

  2018-005038-39

• Clinicaltrials.gov Identifier

  NCT04695080

• Duration of Study in the UK

  3 years, 6 months, 1 days

• Research summary

  MS is a chronic inflammatory and degenerative disease of the central nervous system (CNS) affecting more than 120,000 people in the UK. 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.
  Cladribine tablets are a safe, convenient, highly effective and CNS penetrant DMT for patients with relapsing-remitting 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).

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  20/LO/1161

• Date of REC Opinion

  2 Dec 2020

• REC opinion

  Further Information Favourable Opinion