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

Sponsor
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04934800
Collaborator
Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany (Other)
257
Enrollment
56
Locations
55.6
Anticipated Duration (Months)
4.6
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
257 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual Study Start Date :
Dec 10, 2019
Anticipated Primary Completion Date :
Jul 29, 2024
Anticipated Study Completion Date :
Jul 29, 2024

Arms and Interventions

Arm Intervention/Treatment
Cladribine

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.
Other Names:
  • MAVENCLAD ®

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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]

    2. Percentage of Participants with 6-Month Disability Progression in Expanded Disability Status Scale (EDSS) [Up to 2 years]

    3. Percentage of Participants with 6-Month Disability Progression in Timed 25 Foot Walk (T25FW) [Up to 2 years]

    4. Percentage of Participants with 6-Month Disability Progression in 9-Hole-Peg Test (9HPT) [Up to 2 years]

    5. Percentage of Participants with 6-Month Disability Improvement in Expanded Disability Status Scale (EDSS) [Up to 2 years]

    6. Percentage of Participants with 6-Month Disability Improvement in Timed 25 Foot Walk (T25FW) [Up to 2 years]

    7. Percentage of Participants with 6-Month Disability Improvement in 9-Hole-Peg Test (9HPT) [Up to 2 years]

    8. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [Up to 2 years]

    9. Quality of Life Assessed by Multiple Sclerosis Impact Scale (MSIS-29) [Baseline, Months 12 and 24]

    10. Treatment Satisfaction Assessed by Treatment Satisfaction Questionnaire for Medication Version 1.4 (TSQM v1.4) Scale [Months 6, 12, 18 and 24]

    11. Pharmacoeconomic Data Assessed by Euro Quality of Life Scale (EuroQol) 5-Dimension-3 Level (EQ-5D-3L) Questionnaire [Baseline, Months 12 and 24]

    12. Percentage of Participants With Treatment Adherence [Up to Month 24]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Thrace, Medical School - Neurology Department Alexandroupolis Greece
    2 251 General Air Force Hospital Athens Greece
    3 417 NIMITS Hospital Athens Greece
    4 Aeginiteion Hospital, University of Athens - A' Neurology Department Athens Greece
    5 Attikon University Hospital Athens Greece
    6 Evangelismos Hospital - Neurology Department Athens Greece
    7 Genaral Hospital of Elefsina "Thriasio" Athens Greece
    8 General Hospital of Athens "Evangelismos" Athens Greece
    9 University of Ioannina - Neurology Department, Ioannina Ioannina Greece
    10 University General Hospital of Larissa - Rheumatology Clinic Larissa Greece
    11 Iatriko Palaioy Faliroy, Medical Center - Neurology Department Paleo Faliro Greece
    12 University General Hospital of Patra Patras Greece
    13 General Hospital of Patra "Agios Andreas" Patra Greece
    14 AHEPA General Hospital of Thessaloniki Thessaloniki Greece
    15 General Hospital of Thessaloniki "G. Papanikolaou" Thessaloniki Greece
    16 Interbalkan Hospital of Thessaloniki Thessaloniki Greece
    17 Papageorgiou General Hospital Thessaloniki Thessaloniki Greece
    18 St Luke's Hospital Thessaloniki Greece
    19 Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII) - Dipartimento di Neurologia Bergamo Italy
    20 Fondazione Istituto G.Giglio di Cefalù - Neurologia-Centro Sclerosi Multipla Cefalù Italy
    21 Università degli Studi G. D'Annunzio Chieti Italy
    22 Azienda Ospedaliera Universitaria Arcispedale Sant'Anna - Neurologia Cona Italy
    23 Azienda Socio Sanitaria Territoriale della Valle Olona (presidio di Gallarate) - Neurologia 2 - Sclerosi Multipla Gallarate Italy
    24 ASL 1 Avezzano L'Aquila Sulmona- Ospedale Regionale San Salvatore - Dipartimento di Neurologia L'Aquila Italy
    25 IRCCS Centro Neurolesi Bonino Pulejo - U.O. di Neurofisipatologia ed Ambulatori Messina Italy
    26 Azienda Ospedaliera di Rilievo Nazionale A. Cardarelli - U.O.S. Malattie Degenerative del S.N.C. Napoli Italy
    27 Ospedale Maggiore della carità - Novara Novara Italy
    28 Centro di Riferimento Regionale per la Sclerosi Multipla (CRESM) - SCDO Neurologia Orbassano Italy
    29 Azienda Ospedaliero Universitaria Policlinico Paolo Giaccone - Dipartimento di Neuroscienze Palermo Italy
    30 Azienda Ospedaliera di Udine Ospedale S. Maria della Misericordia - UO Neurologia Perugia Italy
    31 Grande Ospedale Metropolitano "Bianchi Melacrino Morelli - Centro Regionale Epilessia Reggio Calabria Italy
    32 Azienda Ospedaliera San Filippo Neri - Neurologia Roma Italy
    33 Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza - Dip. di Neurologia e Psichiatria (servizio EMG) Roma Italy
    34 A. O. U. San Giovanni Di Dio e Ruggi D'Aragona - Struttura Complessa di Oculistica Salerno Italy
    35 Azienda Ospedaliera Universitaria Integrata Verona (Ospedale Borgo Roma) - D.U.Neurologia Verona Italy
    36 Vestre Viken HF Drammen Sykehus - former Sykehuset Buskerud Drammen Norway
    37 Sykehuset Namsos Namsos Norway
    38 Oslo Universitetssykehus HF - Ullevål Oslo Norway
    39 Uniwersytecki Szpital Kliniczny w Bialymstoku - Dept of Neurology Bialystok Poland
    40 Szpital Specjalistyczny im. L.Rydygiera w Krakowie - Neurology Department Krakow Poland
    41 Szpital Uniwersytecki w Krakowie - Uniwersytet Jagiellonski Collegium Medicum Krakow Poland
    42 Szpital Kliniczny im.Heliodora Swiecickiego Uniwersytetu Medycznego im.K. Marcinkowskiego w Poznaniu - Dept of Neurology Poznan Poland
    43 Pomorski Uniwersytet Medyczny - Klinika Neurologii Szczecin Poland
    44 Wojskowy Instytut Medyczny - Klinika Neurologiczna Warszawa Poland
    45 SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 w Rybniku Zory Poland
    46 Centro Hospitalar de Lisboa Ocidental, E.P.E. - Hospital de Egas Moniz - Serviço de Neurologia Lisboa Portugal
    47 Unidade Local de Saúde de Matosinhos, EPE (Hospital Pedro Hispano) - Serviço de Neurologia Matosinhos Portugal
    48 Centro Hospitalar de São João, E.P.E. - Serviço de Neurologia Porto Portugal
    49 Hospital Garcia de Orta, EPE - Serviço de Neurologia Pragal Portugal
    50 Centro Hospitalar de Setubal, EPE - Hospital São Bernardo Setúbal Portugal
    51 Unidade Local de Saúde do Alto Minho, EPE - Serviço de Neurologia Viana De Castelo Portugal
    52 Inselspital - Universitaetsspital Bern - Neuropsychologische Rehabilitation, Neurologie Bern Switzerland
    53 (CHUV), Centre Hospitalier Universitaire Vaudois - Departement des Neurosciences Cliniques Lausanne Switzerland
    54 Ospedale Regionale di Lugano - Neurologia Lugano Switzerland
    55 Luzerner Kantonsspital - Zentrum fuer Neurologie und Neurorehabilitation Luzern 16 Switzerland
    56 Hôpital Régional Sion-Hérens-Conthey - Neurologie Sion Switzerland

    Sponsors and Collaborators

    • Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    • Merck Hellas sa., Greece, an affiliate of Merck KGaA, Darmstadt, Germany

    Investigators

    • Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    ClinicalTrials.gov Identifier:
    NCT04934800
    Other Study ID Numbers:
    • MS700568_0070
    First Posted:
    Jun 22, 2021
    Last Update Posted:
    Jun 22, 2022
    Last Verified:
    Jun 1, 2022
    Keywords provided by Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
    Multiple Sclerosis
    Cladribine
    MAVENCLAD ®
    Additional relevant MeSH terms:
    Multiple Sclerosis
    Sclerosis
    Cladribine

    Study Results

    No Results Posted as of Jun 22, 2022