Journal article

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)

Vicki E Maltby, Rodney A Lea, Mastura Monif, Marzena J Fabis-Pedrini, Katherine Buzzard, Tomas Kalincik, Allan G Kermode, Bruce Taylor, Suzanne Hodgkinson, Pamela McCombe, Helmut Butzkueven, Michael Barnett, Jeannette Lechner-Scott

JMIR RESEARCH PROTOCOLS | JMIR PUBLICATIONS, INC | Published : 2021

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..

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