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

Status: Completed
Location: See all (61) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

The main aim is 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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
Austria
KH der Barmherzige Brüder Eisenstadt - Neurology
Eisenstadt
Dr. Reinhard Krendl-Head
Sankt Veit An Der Glan
Klinik Florisdorf
Wien
Greece
University of Thrace, Medical School - Neurology Department
Alexandroupolis
251 General Air Force Hospital
Athens
417 NIMITS Hospital
Athens
Aeginiteion Hospital, University of Athens - A' Neurology Department
Athens
Attikon University Hospital
Athens
Evangelismos Hospital - Neurology Department
Athens
Genaral Hospital of Elefsina Thriasio
Athens
General Hospital of Athens Evangelismos
Athens
University of Ioannina - Neurology Department, Ioannina
Ioannina
University General Hospital of Larissa - Rheumatology Clinic
Larissa
Iatriko Palaioy Faliroy, Medical Center - Neurology Department
Paleo Faliro
General Hospital of Patra Agios Andreas
Patra
University General Hospital of Patra
Patras
AHEPA General Hospital of Thessaloniki
Thessaloniki
General Hospital of Thessaloniki G. Papanikolaou
Thessaloniki
Interbalkan Hospital of Thessaloniki
Thessaloniki
Papageorgiou General Hospital Thessaloniki
Thessaloniki
St Luke's Hospital
Thessaloniki
Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia
Bergamo
Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla
Cefalù
Università degli Studi G. D'Annunzio
Chieti
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia
Cona
Ospedali Riuniti di Foggia - Neurology
Foggia
Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla
Gallarate
ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia
L'aquila
Ospedale San Luca - S.C.Oncologia
Lucca
IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori
Messina
Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C.
Napoli
Ospedale Maggiore della carità - Novara
Novara
Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia
Orbassano
Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze
Palermo
Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia
Perugia
Grande Ospedale Metropolitano Bianchi Melacrino Morelli - Centro Regionale Epilessia
Reggio Calabria
Azienda Ospedaliera San Filippo Neri - Neurologia
Roma
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG)
Roma
A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica
Salerno
Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia
Verona
Norway
Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud
Drammen
Sykehuset Namsos
Namsos
Oslo Universitetssykehus HF - Ullevål
Oslo
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology
Bialystok
Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department
Krakow
Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum
Krakow
Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
Poznan
Pomorski Uniwersytet Medyczny - Klinika Neurologii
Szczecin
Wojskowy Instytut Medyczny - Klinika Neurologiczna
Warszawa
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
Zory
Portugal
Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia
Lisboa
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia
Matosinhos
Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia
Porto
Hospital Garcia de Orta, EPE - Serviço de Neurologia
Pragal
Centro Hospitalar de Setubal, EPE - Hospital São Bernardo
Setúbal
Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia
Viana De Castelo
Switzerland
Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
Bern
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
Lausanne
Ospedale Regionale di Lugano - Neurologia
Lugano
Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation
Luzern 16
Hôpital Régional Sion-Hérens-Conthey - Neurologie
Sion
Time Frame
Start Date: 2019-12-10
Completion Date: 2024-05-20
Participants
Target number of participants: 256
Treatments
Cladribine
Related Therapeutic Areas
Sponsors
Collaborators: Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany
Leads: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

This content was sourced from clinicaltrials.gov

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