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Clinical Trials in Poland / NCT05797740
Active, not recruiting Observational

Cladribine Tablets Level of Response Predictors in Clinical Practice (CLODINA)

NCT05797740 · tracked via the Priya Life Science Poland tracker
Phase
Observational
Started
2023-08-03
Last updated
2026-08-07

Condition(s) studied

Multiple Sclerosis

Investigational drug(s) / intervention(s)

Mavenclad →

Mavenclad: This is an observational study, participants who received cladribine tablets in routine clinical practice following the SmPC will be included.

Study summary

This study aims to describe participants characteristics that can predict the safety and effectiveness of cladribine tablets, as assessed by time-to-discontinuation of treatment with cladribine tablets, and to assess other patient-reported, clinical, and imaging outcomes in participants with relapsing multiple sclerosis (RMS) in the long term, in a real-world setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult participants, male or female patients ≥ 18 years old at index date * Participants must voluntarily give written informed consent form (ICF). Patients must read and fully understand the ICF * Participants with confirmed diagnosis of RMS at index date, diagnosed by the treating physician according to applicable clinical practice guidelines (currently McDonald 2017 criteria), with high disease activity. * Required historical data should be available: number of relapses in the 12 months prior to index date, DMTs taken prior to index date, date of MS diagnosis, and data of at least 1 MRI prior to index date as specified in the drug Summary of Product Characteristics (SmPC) * Fulfillment of the indication for treatment with cladribine tablets at index date, per standard of care in accordance with the local SmPC * Meeting 1 of the following criteria: * Prospective participants: Having been prescribed with cladribine tablets or having taken at least one dose of cladribine tablets, with enrollment date prior to the second treatment week * Retrospective participants: Having taken at least one dose of cladribine tablets, with enrollment date during or after the second treatment week but not more than 3 years after the first dose of cladribine tablets Exclusion Criteria: * Contraindications to use of cladribine tablets according to the SmPC. * Any participant who had the first dose of cladribine tablets more than 3 years prior to enrollment * Any participant who is pregnant or plans to breast-feed while taking cladribine tablets, or any patient who or whose partner plans to become pregnant in Year 1 or within 6 months after the last dose in Year 2, or any participants who is unwilling or unable to use contraception per the SmPC * Have participated or participating in an interventional study since cladribine tablet initiation, in which participant assessment and/or treatment may be dictated by a protocol * Participants who, at the discretion of the Investigator, will not be able to provide reliable information for the study

Primary outcome measure(s)

Trial sites (30)

FacilityCityRegionStatus
UCL Saint Luc Brussels Belgium
UZ Antwerpen Edegem Belgium
AZ Groeninge vzw Kortrijk Belgium
CHU Sart Tilman Liège Belgium
FN u sv. Anny Brno Brno Czechia
FN Hradec Králové Hradec Králové Czechia
NeuropsychiatrieHK Hradec Králové Czechia
Fakultni nemocnice Ostrava Ostrava Czechia
Nemocnice Teplice Teplice Czechia
University of Thrace, Medical School - Neurology Department, Alexandroupoli Alexandroupoli Greece
Aiginiteio' Hospital Athens Greece
Attikon Athens Greece
Evagelismos Athens Greece
General Miliary Hospital of Athens "401" Athens Greece
University of Ioannina - Neurology department Ioannina Greece
University Hospital of Larissa Larissa Greece
General Hospital "Agios Andreas" Pátrai Greece
University of Patras Pátrai Greece
AHEPA University Hospital of Thessaloniki Thessaloniki Greece
General Hospital of Athens G.Gennimatas Thessaloniki Greece
Interbalkan Hospital of Thessaloniki Thessaloniki Greece
St Luke's Clinic Thessaloniki Greece
Zuyderland Sittard-Geleen Netherlands
Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie Krakow Poland
Medical Academy Neurology Clinic Poznan Poland
Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie Szczecin Poland
Centro Hospitalar e Universitario de Coimbra Coimbra Portugal
Centro Hospitalar Lisboa Norte Hospital de Santa Maria Lisbon Portugal
Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos Lisbon Portugal
Centro Hospitalar de São João E. P. E. Porto Portugal

More Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany trials in Poland

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05797740 on ClinicalTrials.gov ↗ ← All trials in Poland