Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2019
Efficacy of Cladribine Tablets in high disease activity subgroups of patients with relapsing multiple sclerosis: A post hoc analysis of the CLARITY study.
Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04550455 (A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis), which is not on this map. Cited by 33 papers, 3 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.
A Prospective Biomarker Study in Active Secondary Progressive Multiple Sclerosis (SPMS)Subjects Treated With Cladribine Tablets
Who cites it
33 citing papers in PubMed, 3 syntheses or guidelines pooled it.
- 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
- Immunomodulators and immunosuppressants for relapsing-remitting multiple sclerosis: a network meta-analysis.The Cochrane database of systematic reviews · 2024Pooled it
- Safety and efficacy of cladribine in multiple sclerosis: a systematic review and meta-analysis.Neurological sciences : official journal of the Italian Neurological Society and of the Italian Society of Clinical Neurophysiology · 2023Pooled it
- From Clinical Trial Efficacy to Real-World Effectiveness and Safety: Two-Year Outcomes of Cladribine in Relapsing-Remitting Multiple Sclerosis.Journal of clinical medicine · 2026Article
- Natural flavonoids in multiple sclerosis: molecular insights and emerging therapeutic strategies.Frontiers in immunology · 2026Review
- Cladribine Preserves Normal Central Nervous System Cellular Activity and Promotes Neuroprotection to Oxidative Stress Damage.International journal of molecular sciences · 2025Article
- Privacy-by-Design Approach to Generate Two Virtual Clinical Trials for Multiple Sclerosis and Release Them as Open Datasets: Evaluation Study.Journal of medical Internet research · 2025Article
- Holistic, Long-Term Management of People with Relapsing Multiple Sclerosis with Cladribine Tablets: Expert Opinion from France.Neurology and therapy · 2024Review
- Magnetic Resonance Imaging Evidence Supporting the Efficacy of Cladribine Tablets in the Treatment of Relapsing-Remitting Multiple Sclerosis.CNS drugs · 2024Review
- Real-World Effectiveness of Cladribine for Patients with Multiple Sclerosis: A Sicilian Multicentric Experience (Rewind Study).Current neuropharmacology · 2024Article
- Disease activity 4.5 years after starting cladribine: experience in 264 patients with multiple sclerosis.Therapeutic advances in neurological disorders · 2023Article
- Practical Guidance on the Use of Cladribine Tablets in the Management or Relapsing Multiple Sclerosis: Expert Opinion from Qatar.Degenerative neurological and neuromuscular disease · 2023Review
- Predictors of Cladribine Effectiveness and Safety in Multiple Sclerosis: A Real-World, Multicenter, 2-Year Follow-Up Study.Neurology and therapy · 2022Article
- Early Reduction of MRI Activity During 6 Months of Treatment With Cladribine Tablets for Highly Active Relapsing Multiple Sclerosis: MAGNIFY-MS.Neurology(R) neuroimmunology & neuroinflammation · 2022Article
- Cladribine Tablets for Relapsing-Remitting Multiple Sclerosis: A Clinician's Review.Neurology and therapy · 2022Review
- The protective role of breastfeeding in multiple sclerosis: Latest evidence and practical considerations.Frontiers in neurology · 2022Review
- Position of Cladribine Tablets in the Management of Relapsing-Remitting Multiple Sclerosis: An Expert Narrative Review From the United Arab Emirates.Neurology and therapy · 2021Review
- A Model-Based Economic Evaluation of Cladribine Versus Alemtuzumab, Ocrelizumab and Natalizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis with High Disease Activity in Chile.PharmacoEconomics - open · 2021Article
- Therapeutic Value of Single Nucleotide Polymorphisms on the Efficacy of New Therapies in Patients with Multiple Sclerosis.Journal of personalized medicine · 2021Review
- Real-world effectiveness of cladribine for Australian patients with multiple sclerosis: An MSBase registry substudy.Multiple sclerosis (Houndmills, Basingstoke, England) · 2021Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the CLARITY (CLAdRIbine Tablets treating multiple sclerosis orallY) study, Cladribine Tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis.
objectiveDescribe two clinically relevant definitions for patients with high disease activity (HDA) at baseline of the CLARITY study (utility verified in patients receiving placebo) and assess the treatment effects of Cladribine Tablets 3.5 mg/kg compared with the overall study population.
methodsOutcomes of patients randomised to Cladribine Tablets 3.5 mg/kg or placebo were analysed for subgroups using HDA definitions based on high relapse activity (HRA; patients with ⩾2 relapses during the year prior to study entry, whether on DMD treatment or not) or HRA plus disease activity on treatment (HRA + DAT; patients with ⩾2 relapses during the year prior to study entry, whether on DMD treatment or not, PLUS patients with ⩾1 relapse during the year prior to study entry while on therapy with other DMDs and ⩾1 T1 Gd+ or ⩾9 T2 lesions).
resultsIn the overall population, Cladribine Tablets 3.5 mg/kg reduced the risk of 6-month-confirmed Expanded Disability Status Scale (EDSS) worsening by 47% vs placebo. A risk reduction of 82% vs placebo was seen in both the HRA and HRA + DAT subgroups (vs 19% for non-HRA and 18% for non-HRA + DAT), indicating greater responsiveness to Cladribine Tablets 3.5 mg/kg in patients with HDA. There were consistent results for other efficacy endpoints. The safety profile in HDA patients was consistent with the overall CLARITY population.
conclusionPatients with HDA showed clinical and MRI responses to Cladribine Tablets 3.5 mg/kg that were generally better than, or at least comparable with, the outcomes seen in the overall CLARITY population.
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