Efficacy of Cladribine Tablets as a Treatment for People with Multiple Sclerosis: Protocol for the CLOBAS Study (Cladribine, a Multicenter, Long-Term Efficacy and Biomarker Australian Study)

Abstract

Background: Cladribine tablets (marketed as Mavenclad) are a new oral therapy, which has recently been listed on the pharmaceutical benefits scheme in Australia for the treatment of relapsing multiple sclerosis (MS). The current dosing schedule is for 2 courses given a year apart, which has been shown to be effective for treatment of MS for up to 4 years in 75% of patients (based on annualized relapse rate). However, the reinitiation of therapy after year 4 has not been studied. Objective: This study aims to evaluate the safety and efficacy of cladribine tablets over a 6-year period, according to no evidence of disease activity 3. Methods: This will be a multicenter, 6-year, phase IV, low in..