The magnify-MS study: Mavenclad tablets in active RMS

Background: Cladribine Tablets improve clinical and MRI outcomes in patients with active relapsing multiple sclerosis (RMS), with significant differences versus placebo after 24 weeks. Objective: Describe the design of a study to assess the onset of Cladribine Tablets' clinical and MRI effects in patients with active RMS. Methods: MAGNIFY‐MS is a 2‐year prospective Phase IV trial (including approximately 100 centres in Europe). Eligible patients will receive two years treatment with Cladribine Tablets 3.5 mg/kg cumulative dose. Frequent MRI assessments (including lesion count, lesion volume, brain volume and magnetisation transfer ratio) will be performed at screening, baseline and 1, 2, 3, 6, 12, 15, 18 and 24 months. Various T‐ and B‐cell subtype counts and functional profiling (e.g. cytokine production) will be assessed. Clinical outcomes will include changes in cognition (Symbol Digit Modality Test), disability (Expanded Disability Status Scale/Kurtzke functional system, 9‐hole peg test, timed 25‐foot walk), relapses, no evidence of disease activity (NEDA), no evidence of progression or active disease, (NEPAD) and safety at timepoints up to 24 months. Results: The aim is to recruit 300 patients. The primary endpoint is change in the count of combined unique active lesions at end of 6 months versus baseline. Final outcomes are expected in 2021. Conclusions: MAGNIFY‐MS will provide important information on the effects of Cladribine Tablets, including early MRI changes, insights into effects on a range of disability and cognition markers, and detailed characterization of immune cell reconstitution.