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)
JMIR Research Protocols, Vol.10(10), Art. e24969
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 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.
Details
- Title
- 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)
- Authors/Creators
- V.E. Maltby (Author/Creator) - John Hunter HospitalR.A. Lea (Author/Creator) - University of Newcastle AustraliaM. Monif (Author/Creator) - Box Hill HospitalM.J. Fabis-Pedrini (Author/Creator) - Perron Institute for Neurological and Translational ScienceK. Buzzard (Author/Creator) - Box Hill HospitalT. Kalincik (Author/Creator) - Melbourne HealthA.G. Kermode (Author/Creator) - Perron Institute for Neurological and Translational ScienceB. Taylor (Author/Creator) - Menzies Research InstituteS. Hodgkinson (Author/Creator) - UNSW SydneyP. McCombe (Author/Creator) - The University of QueenslandH. Butzkueven (Author/Creator) - Alfred HealthM. Barnett (Author/Creator) - The University of SydneyJ. Lechner-Scott (Author/Creator) - John Hunter Hospital
- Publication Details
- JMIR Research Protocols, Vol.10(10), Art. e24969
- Publisher
- JMIR Publications
- Identifiers
- 991005540636607891
- Copyright
- © 2021 The Authors.
- Murdoch Affiliation
- Institute for Immunology and Infectious Diseases
- Language
- English
- Resource Type
- Journal article
UN Sustainable Development Goals (SDGs)
This output has contributed to the advancement of the following goals:
Source: InCites
Metrics
166 File views/ downloads
82 Record Views