Prospective Effectiveness and Safety Study of Cladribine in Participants Who Change First-line DMD Treatments for Multiple Sclerosis (CLAD CROSS)

Multiple Sclerosis Clinical Trial

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)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04934800
• Other study ID #: MS700568_0070
• Status: Active, not recruiting
• Start date: December 10, 2019
• Est. completion date: July 29, 2024

Study information

• Verified date: May 2024
• Source: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 256
• Est. completion date: July 29, 2024
• Est. primary completion date: July 29, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Greece	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	General Hospital of Patra "Agios Andreas"	Patra
Greece	University General Hospital of Patra	Patras
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
Italy	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	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
Norway	Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud	Drammen
Norway	Sykehuset Namsos	Namsos
Norway	Oslo Universitetssykehus HF - Ullevål	Oslo
Poland	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
Portugal	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
Switzerland	Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie	Bern
Switzerland	(CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques	Lausanne
Switzerland	Ospedale Regionale di Lugano - Neurologia	Lugano
Switzerland	Hôpital Régional Sion-Hérens-Conthey - Neurologie	Sion

Sponsors (2)

Lead Sponsor	Collaborator
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany	Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany

Countries where clinical trial is conducted

Greece,  Italy,  Norway,  Poland,  Portugal,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS)		Up to 2 years
Secondary	Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW)		Up to 2 years
Secondary	Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT)		Up to 2 years
Secondary	Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS)		Up to 2 years
Secondary	Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW)		Up to 2 years
Secondary	Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT)		Up to 2 years
Secondary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		Up to 2 years
Secondary	Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29)		Baseline, Months 12 and 24
Secondary	Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale		Months 6, 12, 18 and 24
Secondary	Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire		Baseline, Months 12 and 24
Secondary	Percentage of Participants With Treatment Adherence		Up to Month 24

External Links

•   Trial Awareness and Transparency website