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

Last updated: April 8, 2025
Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Memory Loss

Multiple Sclerosis

Scar Tissue

Treatment

Mavenclad

Clinical Study ID

NCT05797740
MS700568_0213
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Adult participants, male or female patients ≥ 18 years old at index date

  • Participants must voluntarily give written informed consent form (ICF). Patientsmust read and fully understand the ICF

  • Participants with confirmed diagnosis of RMS at index date, diagnosed by thetreating physician according to applicable clinical practice guidelines (currentlyMcDonald 2017 criteria), with high disease activity.

  • Required historical data should be available: number of relapses in the 12 monthsprior to index date, DMTs taken prior to index date, date of MS diagnosis, and dataof at least 1 MRI prior to index date as specified in the drug Summary of ProductCharacteristics (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 orhaving taken at least one dose of cladribine tablets, with enrollment dateprior to the second treatment week

  • Retrospective participants: Having taken at least one dose of cladribinetablets, with enrollment date during or after the second treatment week but notmore than 3 years after the first dose of cladribine tablets

Exclusion

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 priorto enrollment

  • Any participant who is pregnant or plans to breast-feed while taking cladribinetablets, or any patient who or whose partner plans to become pregnant in Year 1 orwithin 6 months after the last dose in Year 2, or any participants who is unwillingor unable to use contraception per the SmPC

  • Have participated or participating in an interventional study since cladribinetablet initiation, in which participant assessment and/or treatment may be dictatedby a protocol

  • Participants who, at the discretion of the Investigator, will not be able to providereliable information for the study

Study Design

Total Participants: 360
Treatment Group(s): 1
Primary Treatment: Mavenclad
Phase:
Study Start date:
August 03, 2023
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • UCL Saint Luc

    Bruxelles,
    Belgium

    Site Not Available

  • UZ Antwerpen

    Edegem,
    Belgium

    Site Not Available

  • AZ Groeninge vzw

    Kortrijk,
    Belgium

    Site Not Available

  • CHU Sart Tilman

    Liege 1,
    Belgium

    Site Not Available

  • FN u sv. Anny Brno

    Brno,
    Czechia

    Site Not Available

  • FN Hradec Králové

    Hradec Kralove,
    Czechia

    Site Not Available

  • NeuropsychiatrieHK

    Hradec Kralove,
    Czechia

    Site Not Available

  • Fakultni nemocnice Ostrava

    Ostrava,
    Czechia

    Site Not Available

  • Nemocnice Teplice

    Teplice,
    Czechia

    Site Not Available

  • University of Thrace, Medical School - Neurology Department, Alexandroupoli

    Alexandroupoli,
    Greece

    Site Not Available

  • 251 General Air Force Hospital

    Athens,
    Greece

    Site Not Available

  • Aiginiteio' Hospital

    Athens,
    Greece

    Site Not Available

  • Attikon

    Athens,
    Greece

    Site Not Available

  • Evagelismos

    Athens,
    Greece

    Site Not Available

  • General Miliary Hospital of Athens "401"

    Athens,
    Greece

    Site Not Available

  • General Oncology Hospital "Agioi Anargyroi"

    Athens,
    Greece

    Site Not Available

  • University of Ioannina - Neurology department

    Ioannina,
    Greece

    Site Not Available

  • University Hospital of Larissa

    Larissa,
    Greece

    Site Not Available

  • General Hospital "Agios Andreas"

    Patras,
    Greece

    Site Not Available

  • University of Patras

    Patras,
    Greece

    Site Not Available

  • AHEPA University Hospital of Thessaloniki

    Thessaloniki,
    Greece

    Site Not Available

  • General Hospital of Athens G.Gennimatas

    Thessaloniki,
    Greece

    Site Not Available

  • Interbalkan Hospital of Thessaloniki

    Thessaloniki,
    Greece

    Site Not Available

  • Papageorgiou General Hospital Thessaloniki

    Thessaloniki,
    Greece

    Site Not Available

  • St Luke's Clinic

    Thessaloniki,
    Greece

    Site Not Available

  • Zuyderland

    Sittard-Geleen,
    Netherlands

    Site Not Available

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok,
    Poland

    Site Not Available

  • Oddział Kliniczny Neurologii, Szpital Uniwersytecki w Krakowie

    Krakow,
    Poland

    Site Not Available

  • Medical Academy Neurology Clinic

    Poznan,
    Poland

    Site Not Available

  • Szpital Kliniczny Nr 1 Pomorskiego Uniwersytetu Medycznego w Szczecinie

    Szczecin,
    Poland

    Site Not Available

  • Centro Hospitalar e Universitario de Coimbra

    Coimbra,
    Portugal

    Site Not Available

  • Centro Hospitalar Lisboa Norte Hospital de Santa Maria

    Lisboa,
    Portugal

    Site Not Available

  • Centro Hospitalar Universitário Lisboa Central - Hospital dos Capuchos

    Lisbon,
    Portugal

    Site Not Available

  • Centro Hospitalar de São João E. P. E.

    Porto,
    Portugal

    Site Not Available

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