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    Summary
    EudraCT Number:2017-002632-17
    Sponsor's Protocol Code Number:MS700568_0021
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-01-22
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2017-002632-17
    A.3Full title of the trial
    A 2-year Prospective Study to Assess Health-related Quality of Life in Subjects with Highly-Active Relapsing Multiple Sclerosis Treated with Mavenclad®
    Studio prospettico della durata di 2 anni per valutare la qualità della vita in relazione alla salute in soggetti con sclerosi multipla recidivante altamente attiva trattati con Mavenclad®.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Quality of Life Study for People with Relapsing Multiple Sclerosis
    Studio per valutare la qualità della vita di persone con sclerosi multipla recidivante
    A.3.2Name or abbreviated title of the trial where available
    .
    .
    A.4.1Sponsor's protocol code numberMS700568_0021
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorMERCK KGAA
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number00496151725200
    B.5.5Fax number00496151722000
    B.5.6E-mailservice@merckgroup.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Mavenclad®
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameMavenclad
    D.3.2Product code [.]
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCLADRIBINA
    D.3.9.1CAS number 4291-63-8
    D.3.9.2Current sponsor codeEMD280922
    D.3.9.4EV Substance CodeSUB06635MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing multiple sclerosis
    Sclerosi multipla recidivante
    E.1.1.1Medical condition in easily understood language
    Relapsing multiple sclerosis
    Sclerosi multipla recidivante
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the health related quality of life (HRQoL) through the MSQOL-54 scale in relapsing multiple sclerosis subjects treated with Mavenclad® for 2 years (24 months)
    Valutare la qualità della vita in relazione alla salute (HRQoL) mediante la Scala della qualità della vita nella sclerosi multipla a 54 voci (MSQoL-54) in soggetti con sclerosi multipla recidivante (RMS) altamente attiva trattati con Mavenclad® per 2 anni (24 mesi)
    E.2.2Secondary objectives of the trial
    To assess treatment satisfaction through the TSQM v1.4 questionnaire in highly active RMS relapsing multiple sclerosis subjects at 6 months of treatment
    Valutare la soddisfazione del trattamento mediante il questionario di soddisfazione TSQM v1.4 in soggetti con sclerosi multipla recidivante (RMS) altamente attiva a 6 mesi di trattamento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Male or female subjects = 18 years old;
    • Highly active RMS as defined by:
    - One relapse in the previous year and at least 1 T1 Gadolinium Gd+ lesion or 9 or more T2 lesions, while on therapy with other disease modifying drugs (DMDs);
    - Two or more relapses in the previous year, whether on DMD treatment or not;
    • EDSS score =5.0
    • Soggetti di sesso maschile o femminile = 18 anni di età;
    • RMS altamente attiva come definita di seguito:
    - Una recidiva nell’anno precedente e almeno una lesione in T1 visibile con Gadolinio (Gd+) o 9 o più lesioni in T2, durante la terapia con altri farmaci modificanti la malattia (DMD);
    - Due o più recidive nell’anno precedente, durante il trattamento con DMD o al di fuori dello stesso;
    • Punteggio EDSS = 5,0
    E.4Principal exclusion criteria
    • Positive test for hepatitis C or positive tests for hepatitis B infection: either hepatitis B surface antigen (HBsAg) positive, or positive hepatitis B core antibody (total anti-HBcAb) confirmed by a positive viral polymerase chain reaction (PCR)
    • Current or previous history of immune deficiency disorders including a positive human immunodeficiency virus (HIV) result
    • Currently receiving immunosuppressive or myelosuppressive therapy with, (e.g., monoclonal antibodies, methotrexate, cyclophosphamide, cyclosporine, mitoxantrone or azathioprine), or chronic use of corticosteroids
    • History of tuberculosis, presence of active tuberculosis, or latent tuberculosis
    • Presence of signs of progressive multifocal leukoencephalopathy (PML) detected by MRI, clinical and/or biomarker evaluations or other (than MS) major Central Nervous System disease clinically diagnosed or evidenced in screening MRI
    • Active malignancy and history of malignancy
    • Hypersensitivity to Mavenclad® or to any of the excipients listed in the SmPC
    • Presence or suspect of PML or other (than MS) major Central Nervous System disease clinically diagnosed or evidences in screening MRI
    • Moderate or severe renal impairment (creatinine clearance <60 mL/min)
    • Esiti positivi al test per l'epatite C o positivi all'infezione con epatite B: sia positivi al test di antigene di superficie dell'epatite B (HBsAg) o positivi al test core antibody (total anti-HBcAb) confermato da una PCR positiva ;
    • Anamnesi corrente o precedente di disturbi da immunodeficienza, incluso esito positivo al test del virus di immunodeficienza umana (HIV);
    • Attuale terapia immunosoppressiva o mielosoppressiva, per es. con anticorpi monoclonali, metotressato, ciclofosfamide, ciclosporina, mitoxantrone o azatioprina), oppure uso cronico di corticosteroidi
    • Anamnesi di tubercolosi, presenza di tubercolosi attiva o latente
    • Presenza di sengali di progressiva LMP alla RMI, valutazioni clinche e/o con biomarker or altra (rispetto a SM) diagnosi di patologie maggiori del Sistema Nervoso Centrale clincamente diagnosticate o evidenziate alla MRI.
    • Malignità attiva o storia clinica di malignità
    • Ipersensibilità a Mavenclad o ad uno degli eccipienti elencati nell'RCP
    • Presenza o sospetto di PML o altra patologia maggiore del Sistema Nervoso Centrale (diversa dal MS) clinicamente diagnosticata o evdenziata durante lo screening con MRI
    • Disfunzione renale moderata o grave (clearance della creatinina <60 ml/min).
    E.5 End points
    E.5.1Primary end point(s)
    Changes in MSQoL-54 at 24 months compared to baseline, i.e., the changes in the physical and mental health composite scores
    Variazioni nel MSQoL-54 a 24 mesi rispetto al basale. ad es. modifiche nei risultati compositi sulla salute fisica e mentale
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 24 months compared to baseline
    A 24 mesi rispetto al basale
    E.5.2Secondary end point(s)
    Treatment global satisfaction assessed by TSQM v1.4 at 6 months
    Soddisfazione globale del trattamento valutata mediante il TSQM v1.4 a 6 mesi
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 6 months
    A 6 mesi
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA111
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Austria
    Belgium
    Czechia
    Denmark
    Finland
    France
    Greece
    Hungary
    Ireland
    Italy
    Lithuania
    Netherlands
    Norway
    Portugal
    Slovakia
    Spain
    Sweden
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the trial is defined as the last subject’s End of Trial visit.
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state73
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 406
    F.4.2.2In the whole clinical trial 445
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will not provide any additional care to subjects after they leave the trial because such care should not differ from what is normally expected for subjects with Relapsing Multiple Sclerosis.

    Upon completion of study, subjects will be offered the opportunity of enrolling into an Extension study that may be planned by the Sponsor, for a further 2 years (i.e., until 4 years from first treatment year course). A separate protocol will be followed for the Extension study.
    Il Promotore non offrirà nessuna terapia aggiuntiva ai pazienti alla fine di questo studio in quanto la terapia non sarà diversa dal trattamento standard della Sclerosi Multipla recidivante.
    Alla fine di questo studio sarà offerta ai pazienti la possibilità di partecipare ad uno studio di Estensione che verrà pianificato dal Promotore, per ulteriori 2 anni di trattamento (cioè fino a 4 anni dal primo anno di trattamento). Sarà predisposto un protocollo separato per lo studio di Estensione.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-08
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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