Clinical trial NCT04934800: Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)
Official title: Oral CLADribine in Patients That Change From First-line Disease Modifying Treatments for Multiple Sclerosis: a pROspective effectivenesS and Safety Study (CLAD CROSS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
Cladribine
MAVENCLAD ®
Lead sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany
First posted: 2021-06-22
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with a confirmed diagnosis of Highly Active Relapsing-Remitting Multiple Sclerosis (RRMS).

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12-months pre-baseline up to Year 2 post-baseline
Secondary outcomes:
measure: Change in Annualized Relapse Rate (ARR) Between the Pre-Baseline 12-Month Period Over the 12 Months Period After the Start of Cladribine
timeFrame: 12-months pre-baseline up to Year 1 post-baseline
measure: Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS)
timeFrame: Up to 2 years
measure: Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW)
timeFrame: Up to 2 years
measure: Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT)
timeFrame: Up to 2 years
measure: Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS)
timeFrame: Up to 2 years
measure: Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW)
timeFrame: Up to 2 years
measure: Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT)
timeFrame: Up to 2 years
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 2 years
measure: Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: Baseline, Months 12 and 24
measure: Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale
timeFrame: Months 6, 12, 18 and 24
measure: Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire
timeFrame: Baseline, Months 12 and 24
measure: Percentage of Participants With Treatment Adherence
timeFrame: Up to Month 24
Other outcomes:
Locations:
city: Eisenstadt
country: Austria
facility: KH der Barmherzige Brüder Eisenstadt - Neurology
city: Sankt Veit an der Glan
country: Austria
facility: Dr. Reinhard Krendl-Head
city: Wien
country: Austria
facility: Klinik Florisdorf
city: Alexandroupolis
country: Greece
facility: University of Thrace, Medical School - Neurology Department
city: Athens
country: Greece
facility: 251 General Air Force Hospital
city: Athens
country: Greece
facility: 417 NIMITS Hospital
city: Athens
country: Greece
facility: Aeginiteion Hospital, University of Athens - A' Neurology Department
city: Athens
country: Greece
facility: Attikon University Hospital
city: Athens
country: Greece
facility: Evangelismos Hospital - Neurology Department
city: Athens
country: Greece
facility: Genaral Hospital of Elefsina "Thriasio"
city: Athens
country: Greece
facility: General Hospital of Athens "Evangelismos"
city: Ioannina
country: Greece
facility: University of Ioannina - Neurology Department, Ioannina
city: Larissa
country: Greece
facility: University General Hospital of Larissa - Rheumatology Clinic
city: Paleo Faliro
country: Greece
facility: Iatriko Palaioy Faliroy, Medical Center - Neurology Department
city: Patras
country: Greece
facility: University General Hospital of Patra
city: Patra
country: Greece
facility: General Hospital of Patra "Agios Andreas"
city: Thessaloniki
country: Greece
facility: AHEPA General Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki "G. Papanikolaou"
city: Thessaloniki
country: Greece
facility: Interbalkan Hospital of Thessaloniki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital Thessaloniki
city: Thessaloniki
country: Greece
facility: St Luke's Hospital
city: Bergamo
country: Italy
facility: Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia
city: Cefalù
country: Italy
facility: Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla
city: Chieti
country: Italy
facility: Università degli Studi G. D'Annunzio
city: Cona
country: Italy
facility: Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia
city: Foggia
country: Italy
facility: Ospedali Riuniti di Foggia - Neurology
city: Gallarate
country: Italy
facility: Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla
city: L'Aquila
country: Italy
facility: ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia
city: Lucca
country: Italy
facility: Ospedale San Luca - S.C.Oncologia
city: Messina
country: Italy
facility: IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori
city: Napoli
country: Italy
facility: Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C.
city: Novara
country: Italy
facility: Ospedale Maggiore della carità - Novara
city: Orbassano
country: Italy
facility: Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia
city: Palermo
country: Italy
facility: Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze
city: Perugia
country: Italy
facility: Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia
city: Reggio Calabria
country: Italy
facility: Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia
city: Roma
country: Italy
facility: Azienda Ospedaliera San Filippo Neri - Neurologia
city: Roma
country: Italy
facility: Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG)
city: Salerno
country: Italy
facility: A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia
city: Drammen
country: Norway
facility: Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud
city: Namsos
country: Norway
facility: Sykehuset Namsos
city: Oslo
country: Norway
facility: Oslo Universitetssykehus HF - Ullevål
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department
city: Krakow
country: Poland
facility: Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum
city: Poznan
country: Poland
facility: Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology
city: Szczecin
country: Poland
facility: Pomorski Uniwersytet Medyczny - Klinika Neurologii
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny - Klinika Neurologiczna
city: Zory
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku
city: Lisboa
country: Portugal
facility: Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia
city: Matosinhos
country: Portugal
facility: Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia
city: Porto
country: Portugal
facility: Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia
city: Pragal
country: Portugal
facility: Hospital Garcia de Orta, EPE - Serviço de Neurologia
city: Setúbal
country: Portugal
facility: Centro Hospitalar de Setubal, EPE - Hospital São Bernardo
city: Viana De Castelo
country: Portugal
facility: Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia
city: Bern
country: Switzerland
facility: Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie
city: Lausanne
country: Switzerland
facility: (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano - Neurologia
city: Luzern 16
country: Switzerland
facility: Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation
city: Sion
country: Switzerland
facility: Hôpital Régional Sion-Hérens-Conthey - Neurologie
Study officials:
affiliation: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
name: Medical Responsible
role: STUDY_DIRECTOR
References: