ChariotMS - A National (UK) Phase IIb, Multi-centre, Randomised, Double-blind, Placebo Controlled (1:1) Efficacy Trial With Cost-utility Analysis of Cladribine Tablets (3.5mg/kg Over Two Years) in People With Advanced Multiple Sclerosis. Is Cladribine Superior to Placebo in Protecting Upper Limb Function?
Overview
- Phase
- Phase 2
- Intervention
- Cladribine (MAVENCLAD®)
- Conditions
- Advanced Multiple Sclerosis
- Sponsor
- Queen Mary University of London
- Enrollment
- 204
- Locations
- 22
- Primary Endpoint
- The 9-HPT peg speed (tasks/second) at 24 months
- Status
- Active, not recruiting
- Last Updated
- 7 months ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Cladribine (MAVENCLAD®)
Intervention: Cladribine (MAVENCLAD®)
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
The 9-HPT peg speed (tasks/second) at 24 months
Time Frame: 24 months
To establish whether there is efficacy superiority of cladribine tablets over placebo in reducing deterioration of upper limb function in pwAMS. To investigate whether cladribine tablets 3.5mg/kg over 24 months is an effective DMT in pwAMS as measured using the 9-hole peg test (9HPT) peg speed at 24 months.
9-HPT proportion of patients who do not deteriorate at 24 months
Time Frame: 24 months
Secondary Outcomes
- Change over 24 months of the study in clinical outcome measure: ARAT(Screening, Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: EDSS(Screening, Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: SLCVA(Screening, Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: NFI-MS(Screening, Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: MSIS-29v2(Screening, , Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: SDMT(Screening, Month 6, 12, 18 and 24)
- Preventing loss of brain volume(Screening, Month 6 and 24)
- Preventing new focal demyelinating lesions and T2 burden of disease increase.(Screening, Month 6 and 24)
- Preventing new hypo-intense lesions ("black holes") on T1 weighted MRI(Screening, Month 6 and 24)
- Safety/occurrence of adverse events(Through study completion, an average of 24 months)
- Preventing loss of spinal cord cross sectional area(Screening, Month 6 and 24)
- Change over 24 months of the study in clinical outcome measure: ABILHAND(Screening, Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: T25ftWT(Screening, Month 6, 12, 18 and 24)
- Change over 24 months of the study in clinical outcome measure: WPAI-GH(Baseline, Month 6, 12, 18 and 24)
- Degree of unblinding(Month 24)
- Change over 24 months of the study in clinical outcome measure: EuroQoL EQ-5D-5L(Screening, Month 6, 12, 18 and 24)