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)
Time to Discontinuation of Treatment with Cladribine tablets — Up to 48 months
Trial sites (30)
Facility
City
Region
Status
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
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.
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