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

NCT ID: NCT05797740

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 367 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-08-03
• Study Completion Date: 2029-01-31

Brief 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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

Single cohort

This is a single cohort study enrolling Participants with relapsing multiple sclerosis (RMS), who are prescribed treatment with cladribine tablets in routine clinical practice following the summary of product characteristics (SmPC).

Mavenclad

Intervention Type: DRUG

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

Interventions

Mavenclad

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

Intervention Type: DRUG

Other Intervention Names

Cladribine

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Locations

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

Countries

Belgium; Czechia; Greece; Netherlands; Poland; Portugal

Related Links

https://clinicaltrials.emdgroup.com/en/trial-details/?id=MS700568_0213

Trial Awareness and Transparency website

https://www.merckgroup.com/en/company/contact-us/medinfo-contact-map.html

Medical Information Location Map - Med Info Contacts

Other Identifiers

MS700568_0213

Identifier Type: -

Identifier Source: org_study_id