Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
- Registration Number
- NCT04934800
- Lead Sponsor
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 256
- 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)
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cladribine Cladribine -
- Primary Outcome Measures
Name Time Method Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period Before the End of Study Follow-Up 12-months pre-baseline up to Year 2 post-baseline
- Secondary Outcome Measures
Name Time Method Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS) Up to 2 years Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT) Up to 2 years Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS) Up to 2 years Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW) Up to 2 years Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29) Baseline, Months 12 and 24 Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW) Up to 2 years Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT) Up to 2 years Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Up to 2 years Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale Months 6, 12, 18 and 24 Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire Baseline, Months 12 and 24 Percentage of Participants With Treatment Adherence Up to Month 24 Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period After the Start of Cladribine 12-months pre-baseline up to Year 1 post-baseline
Trial Locations
- Locations (61)
Papageorgiou General Hospital Thessaloniki
🇬🇷Thessaloniki, Greece
University General Hospital of Patra
🇬🇷Patras, Greece
General Hospital of Patra "Agios Andreas"
🇬🇷Patra, Greece
AHEPA General Hospital of Thessaloniki
🇬🇷Thessaloniki, Greece
General Hospital of Thessaloniki "G. Papanikolaou"
🇬🇷Thessaloniki, Greece
Interbalkan Hospital of 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
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
Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia
🇮🇹Reggio Calabria, 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
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
KH der Barmherzige Brüder Eisenstadt - Neurology
🇦🇹Eisenstadt, Austria
Dr. Reinhard Krendl-Head
🇦🇹Sankt Veit an der Glan, Austria
Klinik Florisdorf
🇦🇹Wien, Austria
University of Ioannina - Neurology Department, Ioannina
🇬🇷Ioannina, Greece
Iatriko Palaioy Faliroy, Medical Center - Neurology Department
🇬🇷Paleo Faliro, Greece
Ospedale San Luca - S.C.Oncologia
🇮🇹Lucca, Italy
Pomorski Uniwersytet Medyczny - Klinika Neurologii
🇵🇱Szczecin, Poland
Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation
🇨ðŸ‡Luzern 16, Switzerland
University of Thrace, Medical School - Neurology Department
🇬🇷Alexandroupolis, 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 General Hospital of Larissa - Rheumatology Clinic
🇬🇷Larissa, Greece
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
Wojskowy Instytut Medyczny - Klinika Neurologiczna
🇵🇱Warszawa, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
🇵🇱Zory, Poland
Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia
🇵🇹Lisboa, Portugal
Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia
🇵🇹Matosinhos, 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
🇨ðŸ‡Bern, Switzerland
(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
🇨ðŸ‡Lausanne, Switzerland
Ospedale Regionale di Lugano - Neurologia
🇨ðŸ‡Lugano, Switzerland
Hôpital Régional Sion-Hérens-Conthey - Neurologie
🇨ðŸ‡Sion, Switzerland