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    Summary
    EudraCT Number:2017-002632-17
    Sponsor's Protocol Code Number:MS700568_0021
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-01-25
    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 ConcernedSpain - AEMPS
    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®
    Estudio prospectivo, de dos años de duración, para evaluar la calidad de vida relacionada con la salud en sujetos con esclerosis múltiple recidivante de elevada actividad tratados 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
    Un estudio de calidad de vida en sujetos con esclerosis múltiple recidivante
    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 number+496151725200
    B.5.5Fax number+496151722000
    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 Serono Europe Limited
    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 nameCladribine
    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 INNCLADRIBINE
    D.3.9.1CAS number 4291-63-8
    D.3.9.2Current sponsor codeEMD280922
    D.3.9.3Other descriptive name2-chloro-2'-deoxyadenosine (2-CdA)
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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
    Esclerosis múltiple recidivante
    E.1.1.1Medical condition in easily understood language
    Relapsing multiple sclerosis
    Esclerosis múltiple 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)
    Evaluar la calidad de vida relacionada con la salud (health related quality of life, HRQoL), mediante la escala MSQoL-54, en sujetos con esclerosis múltiple recidivante tratados con Mavenclad® durante 2 años (24 meses)
    E.2.2Secondary objectives of the trial
    To assess treatment satisfaction through the TSQM v1.4 questionnaire in relapsing multiple sclerosis subjects at 6 months of treatment
    Evaluar la satisfacción con el tratamiento, mediante el cuestionario TSQM v1.4, en sujetos con esclerosis múltiple recidivante a los 6 meses de tratamiento
    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 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
    - Varones o mujeres >= 18 años
    - Esclerosis múltiple recidivante de elevada actividad, definida por:
    - Una recidiva en el año anterior y al menos una lesión en T1 Gd+ o bien 9 o más lesiones en T2 durante el tratamiento con otros fármacos modificadores de la esclerosis múltiple (disease modifying drugs, DMD)
    - Dos o más recidivas en el año anterior, con o sin tratamiento con modificadores de la esclerosis múltiple
    - Puntuación EDSS <=5,0
    E.4Principal exclusion criteria
    Positive hepatitis C or hepatitis B surface antigen test and/or core
    antibody test for immunoglobulin G (IgG) and/or immunoglobulin M
    (IgM)
    • 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 or azathioprine, or chronic use of corticosteroids
    • History of tuberculosis, presence of active tuberculosis, or latent
    tuberculosis
    • Presence of PML in 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)
    - Resultado positivo en las pruebas de hepatitis C o del antígeno de superficie del virus de la hepatitis B y/o de anticuerpos contra el antígeno central del virus de la hepatitis B (IgG y/o IgM)
    - Presencia o antecedentes de trastornos por deficiencias inmunitarias, lo que incluye un resultado positivo del virus de la inmunodeficiencia humana (human immunodeficiency virus, HIV)
    - En tratamiento inmunosupresor o mielosupresor actual con, por ejemplo, anticuerpos monoclonales, metotrexato, ciclofosfamida, ciclosporina o azatioprina, o uso prolongado de corticosteroides
    - Antecedentes de tuberculosis, presencia de tuberculosis activa o tuberculosis latente
    - Evidencia de leucoencefalopatía multifocal progresiva (progressive multifocal leukoencephalopathy, PML) en la resonancia magnética
    - Neoplasia maligna activa
    - Hipersensibilidad a Mavenclad® o a cualquiera de los excipientes listados en la ficha técnica
    - Presencia o sospecha de PML u otra (de la EM) enfermedad del Sistema Nervioso Central clínicamente diagnosticada o evidencias en la prueba de MRI
    - Insuficiencia renal moderada o grave (aclaramiento de creatinina <60 ml / min
    E.5 End points
    E.5.1Primary end point(s)
    Changes in MSQoL-54 at 24 months compared to baseline
    Cambios en MSQoL-54 a los 24 meses en comparación con el Basal
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 24 months compared to baseline
    a los 24 meses en comparación con el Basal
    E.5.2Secondary end point(s)
    Treatment satisfaction assessed by TSQM v1.4 at 6 months
    - Satisfacción con el tratamiento, evaluada mediante TSQM v1.4, a los 6 meses
    E.5.2.1Timepoint(s) of evaluation of this end point
    at 6 months
    a los 6 meses
    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 Yes
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA95
    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 No
    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
    Czech Republic
    Denmark
    Finland
    France
    Greece
    Hungary
    Israel
    Italy
    Lithuania
    Netherlands
    Norway
    Poland
    Portugal
    Slovakia
    Spain
    Sweden
    Switzerland
    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.
    El final del ensayo se define como la última visita del ensayo del último sujeto
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days24
    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: 445
    F.1.3Elderly (>=65 years) No
    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 state54
    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.
    El promotor no proprocionará ningún tratamiento adicional a los sujetos una vez hayan abandonado el ensayo, porque el tratamiento no debería ser diferente al que se espera normalmente para los sujetos con Esclerosis Multiple Recidivante.

    Al final del estudio, se ofrecerá a los pacientes la oportunidad de ser incluidos en un estudio de Extensión que puede ser planeado por el promotor, por otros 2 años. Para el estudio de Extensión se seguirá un protocol separado.
    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 Decision2018-03-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-03-01
    P. End of Trial
    P.End of Trial StatusOngoing
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