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 interventional, observational study that incorporates clinical, hematological, bioc

SUBMITTER: Maltby VE 

PROVIDER: S-EPMC8564661 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature