Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
NCT ID: NCT04934800
Last Updated: 2025-06-24
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
256 participants
OBSERVATIONAL
2019-12-10
2024-05-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Suboptimally Controlled Participants Previously Taking Injectable DMDs for RMS (CLICK-MS)
NCT03933215
A Study of Suboptimally Controlled Participants Previously Taking Oral or Infusion DMDs for RMS (MASTER-2)
NCT03933202
A Safety and Efficacy Study of Oral Cladribine in Subjects With Relapsing-remitting Multiple Sclerosis (RRMS)
NCT00213135
Cladribine Tablets as an Exit Therapy Strategy
NCT06887426
Cladribine Tablets: Collaborative Study to Evaluate Impact On Central Nervous System Biomarkers in Multiple Sclerosis
NCT03963375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cladribine
Cladribine
No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cladribine
No intervention will be administered as a part of this study. Participants who had switched from first-line DMD treatments to treatment with cladribine tablets in routine clinical practice will be assessed for 2 years in this study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany
UNKNOWN
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Medical Responsible
Role: STUDY_DIRECTOR
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
General Hospital of Athens "Evangelismos"
Athens, , Greece
University of Ioannina - Neurology Department, Ioannina
Ioannina, , Greece
University General Hospital of Larissa - Rheumatology Clinic
Larissa, , Greece
Iatriko Palaioy Faliroy, Medical Center - Neurology Department
Palaió Fáliro, , Greece
General Hospital of Patra "Agios Andreas"
Pátrai, , Greece
University General Hospital of Patra
Pátrai, , Greece
AHEPA General Hospital of Thessaloniki
Thessaloniki, , Greece
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, , Greece
Interbalkan Hospital of Thessaloniki
Thessaloniki, , Greece
Papageorgiou General Hospital Thessaloniki
Thessaloniki, , Greece
St Luke's Hospital
Thessaloniki, , Greece
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia
Bergamo, , Italy
Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla
Cefalù, , Italy
Università degli Studi G. D'Annunzio
Chieti, , Italy
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia
Cona, , Italy
Ospedali Riuniti di Foggia - Neurology
Foggia, , Italy
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla
Gallarate, , Italy
Ospedale San Luca - S.C.Oncologia
Lucca, , Italy
ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia
L’Aquila, , Italy
IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori
Messina, , Italy
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C.
Napoli, , Italy
Ospedale Maggiore della carità - Novara
Novara, , Italy
Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia
Orbassano, , Italy
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze
Palermo, , Italy
Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia
Perugia, , Italy
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia
Reggio Calabria, , Italy
Azienda Ospedaliera San Filippo Neri - Neurologia
Roma, , Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG)
Roma, , Italy
A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica
Salerno, , Italy
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia
Verona, , Italy
Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud
Drammen, , Norway
Sykehuset Namsos
Namsos, , Norway
Oslo Universitetssykehus HF - Ullevål
Oslo, , Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology
Bialystok, , Poland
Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department
Krakow, , Poland
Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum
Krakow, , Poland
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
Poznan, , Poland
Pomorski Uniwersytet Medyczny - Klinika Neurologii
Szczecin, , Poland
Wojskowy Instytut Medyczny - Klinika Neurologiczna
Warsaw, , Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
Żory, , Poland
Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia
Lisbon, , Portugal
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia
Matosinhos Municipality, , Portugal
Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia
Porto, , Portugal
Hospital Garcia de Orta, EPE - Serviço de Neurologia
Pragal, , Portugal
Centro Hospitalar de Setubal, EPE - Hospital São Bernardo
Setúbal, , Portugal
Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia
Viana de Castelo, , Portugal
Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
Bern, , Switzerland
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
Lausanne, , Switzerland
Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation
Lucerne, , Switzerland
Ospedale Regionale di Lugano - Neurologia
Lugano, , Switzerland
Hôpital Régional Sion-Hérens-Conthey - Neurologie
Sion, , Switzerland
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Trial Awareness and Transparency website
Medical Information Location Map - Med Info Contacts
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MS700568_0070
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.