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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)

Citation

Maltby, VE and Lea, RA and Monif, M and Fabis-Pedrini, MJ and Buzzard, K and Kalincik, T and Kermode, AG and Taylor, BVM and Hodgkinson, S and McCombe, P and Butzkueven, H and Barnett, M and Lechner-Scott, J, 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), JMIR Research Protocols, 10, (10) pp. 1-12. ISSN 1929-0748 (2021) [Refereed Article]


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Copyright Statement

Copyright 2021 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. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.

DOI: doi:10.2196/24969

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, biochemical, epigenetic, radiological and cognitive biomarkers of disease. Participants considered for treatment with cladribine as part of their routine clinical care will be consented to take part in the study. They will be monitored at regular intervals during the initial course of medication administration in years 1 and 2. After year 3, patients will have the option of redosing, 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 magnetic resonance imaging findings (brain volume and/or lesion load) and cognitive performance.

Results: This study has been approved by the Hunter New England Local Health District Human Research Ethics Committee. Recruitment began in March of 2019 and was completed by June 2021.

Conclusions: This will be the first long-term efficacy trial of cladribine, which offers reinitiation of therapy in the 3rd year, based on disease activity, after the initial 2 courses. We expect that this study will indicate whether any of the assessed biomarkers can be used to predict treatment efficacy or the need for future reinitiation of cladribine in people with MS.

Item Details

Item Type:Refereed Article
Keywords:multiple sclerosis, cladribine, biomarkers
Research Division:Biomedical and Clinical Sciences
Research Group:Neurosciences
Research Field:Neurology and neuromuscular diseases
Objective Division:Health
Objective Group:Clinical health
Objective Field:Clinical health not elsewhere classified
UTAS Author:Kermode, AG (Professor Allan Kermode)
UTAS Author:Taylor, BVM (Professor Bruce Taylor)
ID Code:152653
Year Published:2021
Web of Science® Times Cited:1
Deposited By:Menzies Institute for Medical Research
Deposited On:2022-08-23
Last Modified:2022-09-12
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