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ChariotMS - Cladribine to Halt Deterioration in People With Advanced Multiple Sclerosis

Study acronym: ChariotMS
StatusActive, Not Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv17
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 204
    • Eligibility criteria expanded, about 86 words
    • Site details revised at 22 of 22 sites
    v16
  3. Primary completion date: Dec 31, 2024 to Dec 31, 2027v15
  4. Primary completion date: Oct 31, 2024 to Dec 31, 2024v14
  5. Re-verified, no change to tracked fieldsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Dec 31, 2024 to Oct 31, 2024
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
    • Site contacts updated at 1 of 22 sites
    v12
  2. Eligibility criteria expanded, about 109 words
    • Site contacts updated at 1 of 22 sites
    v11
  3. Site contacts updated at 1 of 22 sitesv10
  4. Site details revised at 4 of 22 sitesv9
  5. Site contacts updated at 3 of 22 sitesv8
  6. Primary completion date: Jul 4, 2024 to Dec 31, 2024
    • Study sites: 19 to 22
    • Study completion date: Jul 4, 2024 to Dec 31, 2026
    v7
  7. Site details revised at 2 of 19 sitesv6
  8. Site details revised at 3 of 19 sitesv5
  9. Study sites: 18 to 19
    • Collaborators: 18 to 5
    v4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 20 to 18
    • Start date changed from estimate of May 31, 2021 to Jun 25, 2021
    • Collaborators: 5 to 18
    v3
  11. Start date: Jan 4, 2021 to May 31, 2021v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT04695080
Lead Sponsor Queen Mary University of London
Collaborators: National Institute for Health Research, United Kingdom, Merck Serono Limited, UK, Multiple Sclerosis Society of Great Britain & Northern Ireland, National Multiple Sclerosis Society, Barts & The London NHS Trust
Conditions
(from sponsor)		 Advanced Multiple Sclerosis, Progressive Multiple Sclerosis
Related terms Charcot-Marie-Tooth disease, Type 1F, Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive
Enrollment 204 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov