Evidence map›Paper›PMID 34665152›Full record

ArticleJMIR research protocols2021

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 and 3 more

Open access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in JMIR research protocols, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 4 citations in OpenAlex.

  1. Article
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 1 country.

Vicki E MaltbyDepartment of Neurology, John Hunter Hospital, New Lambton Heights, Australia.ORCID https://orcid.org/0000-0002-3785-4742
Rodney A LeaSchool for Medicine and Public Health, University of Newcastle, Callaghan, Australia.ORCID https://orcid.org/0000-0002-1148-5862
Mastura MonifDepartment of Neurosciences, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Australia.ORCID https://orcid.org/0000-0001-6404-9768
Marzena J Fabis-PedriniCentre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Perth, Australia.ORCID https://orcid.org/0000-0002-2614-8607
Katherine BuzzardDepartment of Neurosciences, Eastern Health Clinical School, Monash University, Box Hill Hospital, Melbourne, Australia.ORCID https://orcid.org/0000-0003-4039-9303
Tomas KalincikDepartment of Neurology, Melbourne Multiple Sclerosis Centre, Melbourne Health, Melbourne, Australia.ORCID https://orcid.org/0000-0003-3778-1376
Allan G KermodeCentre for Neuromuscular and Neurological Disorders, Perron Institute for Neurological and Translational Science, University of Western Australia, Perth, Australia.ORCID https://orcid.org/0000-0002-4476-4016
Bruce TaylorMenzies Institute for Medical Research, University of Tasmania, Hobart, Australia.ORCID https://orcid.org/0000-0003-2807-0070
Suzanne HodgkinsonDepartment of Medicine, University of New South Wales, Sydney, Australia.ORCID https://orcid.org/0000-0002-9029-6663
Pamela McCombeCentre for Clinical Research, University of Queensland, Brisbane, Australia.ORCID https://orcid.org/0000-0003-2704-8517
Helmut ButzkuevenDepartment of Neurology, Alfred Health, Melbourne, Australia.ORCID https://orcid.org/0000-0003-3940-8727
Michael BarnettBrain and Mind Centre, University of Sydney, Sydney, Australia.ORCID https://orcid.org/0000-0002-2156-8864
Jeannette Lechner-ScottDepartment of Neurology, John Hunter Hospital, New Lambton Heights, Australia.ORCID https://orcid.org/0000-0002-3850-447X
Box Hill Hospital · AUJohn Hunter Hospital · AUThe University of Melbourne · AULiverpool Hospital · AUMurdoch University · AUQueensland University of Technology · AUThe University of Queensland · AUThe University of Sydney · AUThe University of Western Australia · AUUniversity of Tasmania · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundCladribine 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.

objectiveThis study aims to evaluate the safety and efficacy of cladribine tablets over a 6-year period, according to no evidence of disease activity 3.

methodsThis 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.

resultsThis 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.

conclusionsThis 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.

trial registrationThis study is registered with the Australian and New Zealand Clinical Trials Registry (ACTRN12619000257167) with Universal Trial Number (U1111-1228-2165). INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/24969.

Indexed as

biomarkerscladribinemultiple sclerosis

Identifiers

PMID34665152
PMCPMC8564661
OpenAlexW3166590900

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.