Trial reportClinical pharmacokinetics2017
Population Pharmacokinetics of Cladribine in Patients with Multiple Sclerosis.
Trial report in Clinical pharmacokinetics, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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
11 citing papers in PubMed.
- Effects of cladribine tablets on heart rate, atrio-ventricular conduction and cardiac repolarization in patients with relapsing multiple sclerosis.British journal of clinical pharmacology · 2019Trial
- Effects of Postponing Treatment in the Second Year of Cladribine Administration: Clinical Trial Simulation Analysis of Absolute Lymphocyte Counts and Relapse Rate in Patients with Relapsing-Remitting Multiple Sclerosis.Clinical pharmacokinetics · 2019Trial
- Effects of cladribine on intrathecal and peripheral B and plasma cells.Clinical and experimental immunology · 2025Article
- Pregnancy effect on disease activity in women with multiple sclerosis treated with cladribine.Journal of neurology · 2024Article
- Model-informed assessment of ethnic sensitivity and dosage justification for Asian populations in the global clinical development and use of cladribine tablets.Clinical and translational science · 2022Review
- Review of Transporter Substrate, Inhibitor, and Inducer Characteristics of Cladribine.Clinical pharmacokinetics · 2021Review
- Effects of disease-modifying therapy on peripheral leukocytes in patients with multiple sclerosis.Journal of neurology · 2021Review
- The Development of Cladribine Tablets for the Treatment of Multiple Sclerosis: A Comprehensive Review.Drugs · 2020Review
- Pregnancy Outcomes During the Clinical Development Program of Cladribine in Multiple Sclerosis: An Integrated Analysis of Safety.Drug safety · 2020Article
- The Clinical Pharmacology of Cladribine Tablets for the Treatment of Relapsing Multiple Sclerosis.Clinical pharmacokinetics · 2019Review
- Practical Evidence-Based Recommendations for Patients with Multiple Sclerosis Who Want to Have Children.Neurology and therapy · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeThe aims of this study were to characterize the concentration-time course of cladribine (CdA) and its main metabolite 2-chloroadenine (CAde), estimate interindividual variability in pharmacokinetics (PK), and identify covariates explaining variability in the PK of CdA.
methodsThis population PK analysis was based on the combined dataset from four clinical studies in patients with multiple sclerosis (MS): three phase I studies, including one food and one drug-drug interaction study, and one phase III clinical study. Plasma and urine concentration data of CdA and CAde were modeled simultaneously.
resultsThe analysis comprised a total of 2619 CdA and CAde plasma and urine concentration observations from 173 patients with MS who received an intravenous infusion or oral tablet doses of CdA as a single agent or in combination with interferon (IFN) β-1a. CdA PK data were best described by a three-compartment model, while a one-compartment model best described the PK of CAde. CdA renal clearance (CL
conclusionsBoth CdA and CAde displayed linear PK after intravenous and oral administration of CdA, with CdA renal function depending on CL
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