134 Cladribine: a multicentre long-term efficacy biomarker australian study (CLOBAS) Article Swipe
Jeannette Lechner‐Scott
,
Vicky Maltby
,
Amanda Lyndon
,
Mastura Monif
,
Trevor J. Kilpatrick
,
Helmut Butzkueven
,
Bruce Taylor
,
Pamela McCombe
,
Suzanne Hodgkinson
,
Marzena J. Fabis‐Pedrini
,
Allan G. Kermode
,
Michael Barnett
,
Tomáš Kalinčík
·
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1136/jnnp-2019-anzan.119
YOU?
·
· 2019
· Open Access
·
· DOI: https://doi.org/10.1136/jnnp-2019-anzan.119
Introduction 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 (based on annualised relapse rate). However, re-initiation of therapy after year 4 has not been studied. Methods This will be a multicentre, 6-year, phase IV, low interventional trial. Subjects considered for treatment with cladribine will receive an initial treatment course in year 1 and a continuing treatment course in year 2. 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 14 th . 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.
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- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1136/jnnp-2019-anzan.119
- https://jnnp.bmj.com/content/jnnp/90/e7/A43.3.full.pdf
- OA Status
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- Cited By
- 1
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W2964833844
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W2964833844Canonical identifier for this work in OpenAlex
- DOI
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https://doi.org/10.1136/jnnp-2019-anzan.119Digital Object Identifier
- Title
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134 Cladribine: a multicentre long-term efficacy biomarker australian study (CLOBAS)Work title
- Type
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articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2019Year of publication
- Publication date
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2019-07-01Full publication date if available
- Authors
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Jeannette Lechner‐Scott, Vicky Maltby, Amanda Lyndon, Mastura Monif, Trevor J. Kilpatrick, Helmut Butzkueven, Bruce Taylor, Pamela McCombe, Suzanne Hodgkinson, Marzena J. Fabis‐Pedrini, Allan G. Kermode, Michael Barnett, Tomáš KalinčíkList of authors in order
- Landing page
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https://doi.org/10.1136/jnnp-2019-anzan.119Publisher landing page
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https://jnnp.bmj.com/content/jnnp/90/e7/A43.3.full.pdfDirect link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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bronzeOpen access status per OpenAlex
- OA URL
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https://jnnp.bmj.com/content/jnnp/90/e7/A43.3.full.pdfDirect OA link when available
- Concepts
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Cladribine, Medicine, Dosing, Clinical trial, Oncology, Multiple sclerosis, Internal medicine, ImmunologyTop concepts (fields/topics) attached by OpenAlex
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1Total citation count in OpenAlex
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2022: 1Per-year citation counts (last 5 years)
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10Other works algorithmically related by OpenAlex
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