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Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS) | Clinical Trials | Clareo Health

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Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)

NCT04934800•Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

View on ClinicalTrials.gov

Summary

The main aim was to study in the real world setting the effectiveness of Cladribine tablets in terms of Annualized Relapse Rate (ARR) and disability progression, in participants who switched from a first line Disease Modifying Drug (DMD) (Interferons, Glatiramer Acetate, Teriflunomide, (Dymethyl fumarate) \[DMF\]) to treatment with Cladribine tablets in routine clinical practice.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with confirmed diagnosis of RRMS diagnosed by the treating physician according to applicable clinical practice guidelines -(currently McDonald 2017 criteria), with high disease activity
•Participants should have been treated with the same first-line DMD (Interferons, Glatiramer Acetate, Teriflunomide, DMF) and at a stable dose for at least one year prior to switch to Cladribine tablets and should have been prescribed Cladribine tablets, according to the decision of the treating physician, prior to enrollment in the study. Any washout period and/or washout methods required before switching (such as elimination of Teriflunomide) must have been conducted, according to the decision of the treating physician
•Required history data should be available: Multiple Sclerosis (MS) data for the 12-months pre-baseline period (annualized relapse rate); MS Medication History (prior DMDs)
•Fulfilment of the criteria for treatment with Cladribine tablets per standard of care in accordance with the local Summary of Product Characteristics (SmPC)

Exclusion Criteria

•Contraindications to use of cladribine tablets according to the SmPC
•Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study
•Participants that have received Cladribine in the past
•Concurrent participation in an investigational study in which participant assessment and/or treatment may be dictated by a protocol

Locations (61)

KH der Barmherzige Brüder Eisenstadt - Neurology

Eisenstadt, Austria

Dr. Reinhard Krendl-Head

Sankt Veit an der Glan, Austria

Klinik Florisdorf

Vienna, Austria

University of Thrace, Medical School - Neurology Department

Alexandroupoli, Greece

251 General Air Force Hospital

Athens, Greece

417 NIMITS Hospital

Athens, Greece

Aeginiteion Hospital, University of Athens - A' Neurology Department

Athens, Greece

Attikon University Hospital

Athens, Greece

Evangelismos Hospital - Neurology Department

Athens, Greece

Genaral Hospital of Elefsina "Thriasio"

Athens, Greece

Key Dates

Start Date

December 10, 2019

Primary Completion Date

May 20, 2024

Completion Date

May 20, 2024

Last Updated

June 24, 2025

Enrollment

256

ACTUAL participants

Conditions

Multiple Sclerosis

Interventions

Cladribine

DRUG

Intermittent Hypoxia in Persons With Multiple Sclerosis

NCT06276634

Multiple SclerosisMultiple Sclerosis-Relapsing-Remitting+1 more

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RECRUITINGPHASE3

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

NCT07225504

Secondary Progressive Multiple Sclerosis (SPMS)

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: June 24, 2025Data 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.

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Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Inclusion Criteria

Exclusion Criteria

Intermittent Hypoxia in Persons With Multiple Sclerosis

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