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NCT04934800Completed

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)

Source: ClinicalTrials.gov · Last updated 24 Jun 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
256 (actual)
First submitted
17 Jun 2021
Start date
10 Dec 2019
Primary completion date
20 May 2024
Lead sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
NCT number
NCT04934800

What you commit to

  • Study type: Observational
  • Participants enrolled: 256
  • From 10 Dec 2019 to the primary completion date, 20 May 2024
  • 61 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Participants with history of alcohol or drug abuse that could potentially interfere with their participation in the study

Other

  • Contraindications to use of cladribine tablets according to the SmPC

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (61)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
KH der Barmherzige Brüder Eisenstadt - Neurology
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EisenstadtAustriaUnknown status
Dr. Reinhard Krendl-Head
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Sankt Veit an der GlanAustriaUnknown status
Klinik Florisdorf
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ViennaAustriaUnknown status
Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
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BernSwitzerlandUnknown status
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
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LausanneSwitzerlandUnknown status
Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation
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LucerneSwitzerlandUnknown status
Ospedale Regionale di Lugano - Neurologia
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LuganoSwitzerlandUnknown status
Hôpital Régional Sion-Hérens-Conthey - Neurologie
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SionSwitzerlandUnknown status
University of Thrace, Medical School - Neurology Department
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AlexandroupoliGreeceUnknown status
Aeginiteion Hospital, University of Athens - A' Neurology Department
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AthensGreeceUnknown status
General Hospital of Athens "Evangelismos"
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AthensGreeceUnknown status
417 NIMITS Hospital
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AthensGreeceUnknown status
251 General Air Force Hospital
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AthensGreeceUnknown status
Attikon University Hospital
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AthensGreeceUnknown status
Genaral Hospital of Elefsina "Thriasio"
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AthensGreeceUnknown status
Evangelismos Hospital - Neurology Department
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AthensGreeceUnknown status
University of Ioannina - Neurology Department, Ioannina
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IoanninaGreeceUnknown status
University General Hospital of Larissa - Rheumatology Clinic
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LarissaGreeceUnknown status
Iatriko Palaioy Faliroy, Medical Center - Neurology Department
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Palaió FáliroGreeceUnknown status
University General Hospital of Patra
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PátraiGreeceUnknown status
General Hospital of Patra Agios Andreas
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PátraiGreeceUnknown status
AHEPA General Hospital of Thessaloniki
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ThessalonikiGreeceUnknown status
Interbalkan Hospital of Thessaloniki
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ThessalonikiGreeceUnknown status
General Hospital of Thessaloniki "G. Papanikolaou"
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ThessalonikiGreeceUnknown status
Papageorgiou General Hospital Thessaloniki
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ThessalonikiGreeceUnknown status
St. Luke's Hospital
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ThessalonikiGreeceUnknown status
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia
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BergamoItalyUnknown status
Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla
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CefalùItalyUnknown status
Università degli Studi G. D'Annunzio
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ChietiItalyUnknown status
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia
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ConaItalyUnknown status
Ospedali Riuniti di Foggia - Neurology
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FoggiaItalyUnknown status
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla
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GallarateItalyUnknown status
ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia
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L’AquilaItalyUnknown status
Ospedale San Luca - S.C.Oncologia
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LuccaItalyUnknown status
IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori
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MessinaItalyUnknown status
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C.
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NaplesItalyUnknown status
Ospedale Maggiore della carità - Novara
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NovaraItalyUnknown status
Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia
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OrbassanoItalyUnknown status
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze
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PalermoItalyUnknown status
Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia
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PerugiaItalyUnknown status
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia
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Reggio CalabriaItalyUnknown status
Azienda Ospedaliera San Filippo Neri - Neurologia
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RomaItalyUnknown status
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG)
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RomaItalyUnknown status
A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica
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SalernoItalyUnknown status
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia
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VeronaItalyUnknown status
Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud
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DrammenNorwayUnknown status
Sykehuset Namsos
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NamsosNorwayUnknown status
Oslo universitetssykehus HF, Ullevål
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OsloNorwayUnknown status
Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology
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BialystokPolandUnknown status
Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department
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KrakowPolandUnknown status
Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum
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KrakowPolandUnknown status
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
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PoznanPolandUnknown status
Pomorski Uniwersytet Medyczny - Klinika Neurologii
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SzczecinPolandUnknown status
Wojskowy Instytut Medyczny - Klinika Neurologiczna
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WarsawPolandUnknown status
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
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ŻoryPolandUnknown status
Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia
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LisbonPortugalUnknown status
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia
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Matosinhos MunicipalityPortugalUnknown status
Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia
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PortoPortugalUnknown status
Hospital Garcia de Orta, EPE - Serviço de Neurologia
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PragalPortugalUnknown status
Centro Hospitalar de Setubal, EPE - Hospital São Bernardo
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SetúbalPortugalUnknown status
Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia
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Viana de CasteloPortugalUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.