Loading clinical trials...

ACTIVE_NOT_RECRUITING

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

NCT05797740•Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (30)

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

Key Dates

Start Date

August 3, 2023

Primary Completion Date

January 31, 2029

Completion Date

January 31, 2029

Last Updated

February 19, 2026

Enrollment

367

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

Mavenclad

DRUG

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

View study

RECRUITINGNA

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Remibrutinib in Secondary Progressive Multiple Sclerosis

Intermittent Hypoxia in Persons With Multiple Sclerosis

Factorial Optimization Trial to Test Cognitive Behavioral Therapy Components for Multiple Sclerosis Fatigue

Assessing Changes in Multi-parametric MRI in MS Patients Taking Clemastine Fumarate as a Myelin Repair Therapy

Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

Cognitive Performance, Sleep Disturbances and Fatigue in Multiple Sclerosis