Trial reportEuropean journal of neurology2023
Reduction in grey matter atrophy in patients with relapsing multiple sclerosis following treatment with cladribine tablets.
Trial report in European journal of neurology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.
What it found
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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.
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.
Who cites it
16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.
- Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model.Health technology assessment (Winchester, England) · 2026Pooled it
- Safety and efficacy of oral cladribine in relapsing multiple sclerosis: a systematic review and meta-analysis.BMC neurology · 2025Pooled it
- Treatment effects of cladribine tablets on data-driven patterns of regional grey matter atrophy in multiple sclerosis.Multiple sclerosis (Houndmills, Basingstoke, England) · 2025Trial
- Reduction in grey matter atrophy in patients with relapsing multiple sclerosis following treatment with cladribine tablets.European journal of neurology · 2023Trial
- The effect of cladribine tablets on intrathecal inflammation in relapsing-remitting multiple sclerosis.Journal of neuroinflammation · 2026Article
- Subcortical volume alterations indicate structural atrophy patterns over time in relapsing-remitting multiple sclerosis: a volBrain-based analysis.Irish journal of medical science · 2025Article
- A drug evaluation narrative review of cladribine as a treatment for multiple sclerosis.Neurodegenerative disease management · 2025Review
- Is therapy-free remission a realistic goal with cladribine tablets in multiple sclerosis? New insights into the mechanism of action and clinical implications of immune reconstitution with cladribine tablets in MS therapy.Journal of neurology · 2025Review
- A Window into New Insights on Progression Independent of Relapse Activity in Multiple Sclerosis: Role of Therapies and Current Perspective.International journal of molecular sciences · 2025Review
- Cladribine tablets in the new multiple sclerosis era.Therapeutic advances in neurological disorders · 2025Review
- Assessment of the impact of reconstitution therapies-cladribine tablets and alemtuzumab-on the atrophy progression among patients with relapse-remitting multiple sclerosis.Frontiers in neuroscience · 2025Article
- Amygdala volume changes as a potential marker of multiple sclerosis progression: links to EDSS scores and PIRA.Frontiers in immunology · 2025Article
- Assessment of brain atrophy as a promising marker of radiological activity in patients with relapsing-remitting multiple sclerosis.Frontiers in neuroscience · 2025Article
- Real-world analysis of brain atrophy in multiple sclerosis patients with an artificial intelligence based software tool.Neurological research and practice · 2024Article
- Decoding Gray Matter Involvement in Multiple Sclerosis via Imaging.Neuroimaging clinics of North America · 2024Review
- Magnetic Resonance Imaging Evidence Supporting the Efficacy of Cladribine Tablets in the Treatment of Relapsing-Remitting Multiple Sclerosis.CNS drugs · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
background and purposeMeasures of atrophy in the whole brain can be used to reliably assess treatment effect in clinical trials of patients with multiple sclerosis (MS). Trials assessing the effect of treatment on grey matter (GM) and white matter (WM) atrophy are very informative, but hindered by technical limitations. This study aimed to measure GM and WM volume changes, using a robust longitudinal method, in patients with relapsing MS randomized to cladribine tablets 3.5 mg/kg or placebo in the CLARITY study.
methodsWe analysed T1-weighted magnetic resonance sequences using SIENA-XL, from 0 to 6 months (cladribine, n = 267; placebo, n = 265) and 6 to 24 months (cladribine, n = 184; placebo, n = 186). Mean percentage GM and WM volume changes (PGMVC and PWMVC) were compared using a mixed-effect model.
resultsMore GM and WM volume loss was found in patients taking cladribine versus those taking placebo in the first 6 months of treatment (PGMVC: cladribine: -0.53 vs. placebo: -0.25 [p = 0.045]; PWMVC: cladribine: -0.49 vs. placebo: -0.34 [p = 0.137]), probably due to pseudoatrophy. However, over the period 6 to 24 months, GM volume loss was significantly lower in patients on cladribine than in those on placebo (PGMVC: cladribine: -0.90 vs. placebo: -1.27 [p = 0.026]). In this period, volume changes in WM were similar in the two treatment arms (p = 0.52).
conclusionsAfter a short period of pseudoatrophy, treatment with cladribine 3.5 mg/kg significantly reduced GM atrophy in comparison with placebo. This supports the relevance of GM damage in MS and may have important implications for physical and cognitive disability progression.
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Registered trials
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.