134 Cladribine: a multicentre long-term efficacy biomarker australian study (CLOBAS)

Abstract

Background: Cladribine tablets (marketed as Mavenclad®) is a new oral therapy, which has recently been listed on the pharmaceuticals benefit scheme (PBS) in Australia for treatment of relapsing MS. The current dosing schedule is for 2 courses given a year apart, which has been shown to be effective for treatment of MS up to 4 years in 75% of patients Objectives: Explore long-term NEDA status or patient and re-treatment. Methods: This will be a multicentre, 6-year, phase IV, low interventional trial. Subjects considered for treatment with cladribine willreceiveaninitialtreatmentcourseinyear1andacontinuing treatmentcourse in year2. After year 3, patients will have the option for re-dosing, if clinically indicated or to switch to another disease modifying therapy. Throughout the duration of the study we will assess blood-based biomarkers including lymphocyte subsets, serum neurofilament light chain, DNA methylation and RNA analysis as well as MRI findings (brain volume/ lesion load) and cognitive performance. Results: This study has been approved by the Hunter New England Local Health District Human Research Ethics Committee. The study is due to commence on March 14th. Conclusions: This will be the first long-term efficacy trial of cladribine which offers re-initiation of therapy after the initial two courses. We expect this study will be an indication if any of the assessed biomarkers can be used to predict treatment efficacy or the need for re-initiation of Cladribine in MS patients.