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    Summary
    EudraCT Number:2015-000922-12
    Sponsor's Protocol Code Number:TV44400-CNS-40083
    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:2018-02-28
    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 number2015-000922-12
    A.3Full title of the trial
    A Multinational, Multicenter, Randomized, Parallel Group, Open-Label Study
    to Assess Medication Satisfaction in Patients with Relapsing Remitting
    Multiple Sclerosis (RRMS) Treated with Subcutaneous Injections of
    Copaxone® (Glatiramer Acetate) 40 mg/mL Three Times a Week Compared
    to 20 mg/mL Daily (CONFIDENCE)
    Studio multinazionale, multicentrico, randomizzato, a gruppi paralleli, in aperto per valutare la soddisfazione del trattamento in pazienti con sclerosi multipla recidivante-remittente (SMRR) trattati con iniezioni sottocutanee di Copaxone® (glatiramer acetato) 40 mg/ml tre volte alla settimana, rispetto a 20 mg/ml giornalieri (CONFIDENCE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to assess medication satisfaction in patients with Relapsing
    Remitting Multiple Sclerosis (RRMS) treated with Copaxone 40 mg/ml
    Three Times a Week compared to Copaxone 20 mg/ml daily
    Studio clinico per valutare la soddisfazione per verso il trattamento in pazienti con sclerosi multipla recidivante-remittente (SMRR) trattati con Copaxone 40 mg/ml tre volte alla settimana rispetto a Copaxone 20 mg/ml al giorno
    A.3.2Name or abbreviated title of the trial where available
    CONFIDENCE
    CONFIDENCE
    A.4.1Sponsor's protocol code numberTV44400-CNS-40083
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberISRCTN00000000
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT00000000
    A.5.3WHO Universal Trial Reference Number (UTRN)U0000-0000-0000
    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 SponsorTEVA BRANDED PHARMACEUTICAL PRODUCTS R&D, INC
    B.1.3.4CountryIsrael
    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 supportTeva Pharmaceutical Industries, Ltd
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTeva Pharma GmbH
    B.5.2Functional name of contact pointClinical Trial Information Desk
    B.5.3 Address:
    B.5.3.1Street AddressWaldecker Str. 7
    B.5.3.2Town/ cityMoerfelden-Walldorf
    B.5.3.3Post code64546
    B.5.3.4CountryGermany
    B.5.4Telephone number000
    B.5.5Fax number000
    B.5.6E-mailinfo-era-clinical@teva.de
    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 COPAXONE - "20 MG/ML SOLUZIONE INIETTABILE IN SIRINGHE PRERIEMPITE" 30 SIRINGHE
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMACEUTICALS LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLATIRAMER ACETATO
    D.3.9.1CAS number 147245-92-9
    D.3.9.2Current sponsor codeGLATIRAMER ACETATE
    D.3.9.3Other descriptive nameGLATIRAMER ACETATO
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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.IMP: 2
    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 COPAXONE - "40 MG/ML SOLUZIONE INIETTABILE IN SIRINGA PRERIEMPITA" 12 SIRINGHE PRERIEMPITE DA 1 ML CON AGO
    D.2.1.1.2Name of the Marketing Authorisation holderTEVA PHARMACEUTICALS LIMITED
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMP
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGLATIRAMER ACETATO
    D.3.9.1CAS number 147245-92-9
    D.3.9.2Current sponsor codeGLATIRAMER ACETATE
    D.3.9.3Other descriptive nameGLATIRAMER ACETATO
    D.3.9.4EV Substance CodeSUB13971MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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-Remitting Multiple Sclerosis (RRMS)
    Sclerosi multipla recidivante-remittente (SMRR)
    E.1.1.1Medical condition in easily understood language
    Relapsing-Remitting Multiple Sclerosis (RRMS)
    Sclerosi multipla recidivante-remittente (SMRR)
    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 20.0
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting 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
    The primary objective of this study is to compare patient medication
    satisfaction as measured by the Medication Satisfaction Questionnaire
    (MSQ) scores between the Copaxone 40 mg/mL three times a week
    (TIW) group and the Copaxone 20 mg/mL once daily (QD) group over 6
    months of treatment.
    L'obiettivo primario di questo studio è mettere a confronto la soddisfazione del paziente verso il trattamento, misurata in base ai punteggi del Questionario di Soddisfazione del Farmaco (MSQ), tra il gruppo trattato con Copaxone 40 mg/ml tre volte la settimana (TIW) e il gruppo trattato con Copaxone 20 mg/ml una volta al giorno (QD) nell'arco di 6 mesi di trattamento.
    E.2.2Secondary objectives of the trial
    - To compare the convenience perception as measured by the
    convenience scale within the Treatment Satisfaction Questionnaire for
    Medication (TSQM-9) in patients treated with subcutaneous (SC)
    injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6
    months of treatment
    - To compare symptomatic changes as determined by the Multiple
    Sclerosis Quality of Life Inventory (MSQLI) subscales Modified Fatigue
    Impact Scale (MFIS) and Mental Health Inventory (MHI) in patients
    treated with SC injection of Copaxone 40 mg/mL TIW vs. Copaxone 20
    mg/mL QD over 6 months of treatment
    - To compare patient's depressive symptoms as measured by Beck
    Depression Inventory II (BDI-II) scale in patients treated with SC
    injection of Copaxone 40 mg/mL TIW vs. Copaxone 20 mg/mL QD over 6
    months of treatment
    The exploratory and other objectives of the study are detailed in the
    study protocol.
    •Mettere a confronto la percezione di convenienza misurata mediante la scala di convenienza del Questionario sulla soddisfazione del trattamento per i medicinali (TSQM-9) in pazienti trattati con iniezione sottocutanea (SC) di Copaxone 40 mg/ml TIW rispetto a Copaxone 20 mg/ml QD nell'arco di 6 mesi di trattamento
    •Mettere a confronto le variazioni dei sintomi determinate in base alle sottoscale del Questionario sulla qualità della vita con la Sclerosi Multipla (MSQLI), Scala di Impatto della Fatica Modificato (MFIS) e il Questionario sulla Salute Mentale (MHI) in pazienti trattati con iniezioni SC di Copaxone 40 mg/ml TIW rispetto a Copaxone 20 mg/ml QD nell'arco di 6 mesi di trattamento
    •Mettere a confronto i sintomi di depressione del paziente misurati mediante la scala del Questionario Beck sulla Depressione II (BDI II) in pazienti trattati con iniezione SC di Copaxone 40 mg/ml TIW rispetto a Copaxone 20 mg/ml QD nell'arco di 6 mesi di trattamento.Vedi prot. per altri obiettivi.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Neuroimmunological Ancillary Study: The neuroimmunological ancillary
    study has the following objectives:
    - To compare throughout the study, the cytokine profile induced in the
    Copaxone 40 mg/mL TIW group as compared to baseline.
    - To compare throughout the study, the distribution of T and B cells
    subpopulations as measured by flow cytometry in the Copaxone 40
    mg/mL TIW group as compared to baseline.
    - To compare throughout the study, the levels of neurotrophic and
    gliotrophic factors (platelet-derived growth factor [PDGF], nerve growth
    factor [NGF], brain-derived neurotrophic factor [BDNF], and epidermal
    growth factor core domain peptide of neuregulin-1 [eNRG1]) in the
    Copaxone 40 mg/mL TIW group as compared to baseline.
    Studio neuroimmunologico di supporto: Lo studio neuroimmunologico di supporto ha i seguenti obiettivi:
    • Mettere a confronto, per tutta la durata dello studio, il profilo delle citochine indotto nel gruppo trattato con Copaxone 40 mg/ml TIW rispetto al basale.
    • Mettere a confronto, per tutta la durata dello studio, la distribuzione delle sottopopolazioni di linfociti T e B misurata con citometria a flusso nel gruppo trattato con Copaxone 40 mg/ml TIW rispetto al basale.
    • Mettere a confronto, per tutta la durata dello studio, i livelli dei fattori neurotrofici e gliotrofici (fattore di crescita derivato dalle piastrine [PDGF], fattore di crescita nervoso [NGF], fattore neurotrofico derivato dal cervello [BDNF] e peptide del dominio core del fattore di crescita epidermico di neuregulina1 [eNRG1]) nel gruppo trattato con Copaxone 40 mg/ml TIW rispetto al valore basale.
    E.3Principal inclusion criteria
    Patients may be included in the study only if they meet all of the
    following criteria:
    a. Men or women at least 18 years of age or older
    b. Patients must have a confirmed and documented RRMS diagnosis, as
    defined by the Revised
    McDonald criteria (Polman et al 2011).
    c. Patients must be ambulatory with a Kurtzke Expanded Disability
    Status Scale (EDSS) score of 0 to 5.5 at Screening visit.
    d. Patients must be in a stable neurological condition, relapse-free and
    free of any corticosteroid treatment (intravenous [IV], intramuscular
    [IM] and/or per os [PO]) or adrenocorticotrophic hormone (ACTH), 30
    days prior to randomization.
    e. Women of child-bearing potential must have a negative serum
    pregnancy test at screening visit and must practice a highly effective
    method of birth control. Highly effective methods of birth control are
    defined as those, alone or in combination, that result in a low failure rate
    (ie, less than 1% per year) when used consistently and correctly. Highly
    effective methods of birth control in this study include: combined
    (estrogen and progestogen containing) or progestogen‑only hormonal
    contraception associated with inhibition of ovulation, intrauterine
    device, intrauterine hormone‑releasing system, bilateral tubal
    occlusion, vasectomized partner, and sexual abstinence.
    f. Patients must be able to sign and date a written informed consent
    prior to entering the study.
    g. Patients must be willing and able to comply with the protocol
    requirements for the duration of the study.
    soggetti potranno essere inclusi nello studio solo se soddisfano tutti i seguenti criteri:
    a. Uomini e donne di età almeno pari o superiore a 18 anni
    b. I pazienti devono avere una diagnosi confermata e documentata di RRMS, definita in base ai criteri di McDonald revisionati (Polman et al 2011).
    c. I pazienti devono essere deambulanti con un punteggio sulla Scala espansa dello stato di disabilità (EDSS) Kurtzke da 0 a 5,5 alla visita di screening.
    d. I pazienti devono essere in condizione neurologica stabile, liberi da ricadute e non in trattamento con corticosteroidi (per via endovenosa [IV], intramuscolare [IM] e/o orale [PO]) o ormone adrenocorticotropo (ACTH), da 30 giorni prima della randomizzazione.
    e. Le donne in età fertile devono presentare un test di gravidanza sul siero negativo alla visita di screening e devono utilizzare un metodo contraccettivo altamente efficace. Sono definiti metodi contraccettivi altamente efficaci i metodi che, usati da soli o in combinazione con altri metodi, presentano un basso tasso di insuccesso (ovvero inferiore all'1% l'anno) se impiegati in modo costante e corretto. I metodi contraccettivi altamente efficaci in questo studio sono: contraccettivi ormonali combinati (contenenti estrogeni e progesterone) oppure a base di solo progesterone, in combinazione con inibitori dell'ovulazione, dispositivo intrauterino, dispositivo intrauterino a rilascio ormonale, occlusione bilaterale delle tube, partner vasectomizzato e astinenza sessuale.
    f. I pazienti devono essere in grado di firmare e datare un consenso informato scritto prima dell'ingresso nello studio.
    g. I pazienti devono essere disposti a e in grado di aderire ai requisiti del protocollo per tutta la durata dello studio.
    E.4Principal exclusion criteria
    Patients will be excluded from participating in this study if they meet
    any of the following
    criteria:
    a. Patient had any contraindication to Copaxone therapy.
    b. Previous use of Copaxone 40 mg/mL TIW.
    c. Patients with progressive forms of MS.
    d. Patients with neuromyelitis optica.
    e. Use of experimental or investigational drugs, and/or participation in
    drug clinical studies within the 6 months prior to screening.
    f. Patients who have been treated with:
    - immunosuppressive medications such as azathioprine or methotrexate
    within 6 months prior
    to the first visit
    - immunoglobulins and/or monoclonal antibodies (including
    natalizumab) within at least
    3 months prior to inclusion
    - alemtuzumab, cladribine, cyclophosphamide or mitoxantrone at any
    time
    g. Chronic (more than 30 consecutive days) systemic (IV, PO or IM)
    corticosteroid treatment within 6 months prior to screening visit.
    h. Pregnancy or breastfeeding.
    i. Clinically significant or unstable medical or surgical condition that would preclude safe and complete study participation
    j. Employees of the clinical study site or any other individuals involved
    with the conduct of the study, or immediate family members of such
    individuals.
    I pazienti saranno esclusi dalla partecipazione a questo studio se soddisfano uno dei seguenti criteri:
    a. Il/la paziente presenta qualsiasi controindicazione alla terapia con Copaxone.
    b. Uso precedente di Copaxone 40 mg/ml TIW.
    c. Pazienti affetti da forme progressive di SM.
    d. Pazienti affetti da neuromielite ottica.
    e. Uso di farmaci sperimentali o in studio e/o partecipazione a studi clinici su farmaci entro i 6 mesi che precedono lo screening.
    f. Pazienti che sono stati trattati con:
    ○ farmaci immunosoppressivi come azatioprina o metotrexato entro i 6 mesi che precedono la prima visita
    ○ immunoglobuline e/o anticorpi monoclonali (incluso natalizumab) entro almeno 3 mesi prima dell'inclusione
    ○ alemtuzumab, cladribina, ciclofosfamide o mitoxantrone in qualsiasi momento
    g. Trattamento cronico (più di 30 giorni consecutivi) con corticosteroidi sistemici (IV, PO o IM) entro 6 mesi prima della visita di screening.
    h. Essere in gravidanza o allattamento.
    i. Condizione clinica o chirurgica clinicamente significativa o instabile, che impedirebbe la partecipazione sicura e completa allo studio
    j. Dipendenti del centro dello studio clinico o qualsiasi altro soggetto coinvolto nella conduzione dello studio o familiari diretti di tali soggetti
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint(s):
    - MSQ scores over 6 months of treatment.
    Endpoint di efficacia primari(o):
    - Punteggi MSQ nell'arco di 6 mesi di trattamento.

    E.5.1.1Timepoint(s) of evaluation of this end point
    Primary Efficacy Measure and Time Point: Medication satisfaction will be assessed with the MSQ at months 0 (baseline, except for treatment naïve patients), 1, 3, 6 (end of core phase), 9, and 12 (end of extension phase), and the ETD visit (if applicable). In addition MSQ will be SRFH on
    days 1 to 7.
    Misure di efficacia primarie e punti temporali: La soddisfazione del farmaco sarà valutata con il MSQ ai mesi 0 (basale, fatta eccezione per i pazienti naïve al trattamento), 1, 3, 6 (fine della fase principale), 9 e 12 (fine della fase di estensione), e alla visita ETD (se applicabile). Inoltre il MSQ sarà SRFH nei giorni da 1 a 7.
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - Convenience perception as measured by the convenience scale within
    TSQM-9 over 6 months of treatment
    - Symptomatic changes as determined by the MSQLI subscales MFIS and
    MHI over 6 months of
    treatment
    - Depressive symptoms as measured by BDI-II scale over 6 months of
    treatment
    Exploratory Endpoints:
    - Gene expression profiles of patients over 6 and 12 months of treatment
    (patients previously naïve to Copaxone only)
    - Associations between genetics and selected clinical and exploratory
    endpoints over 6 and 12 months of treatment
    - Retention rate at 6, 9, and 12 months.
    - Adherence to treatment as measured by the MS-TAQ scale over 6
    months of treatment
    - For patients who use the CSYNC device, device satisfaction after 1, 6,
    and 12 months of treatment
    - Evaluation of key variables at 9 and 12 months
    Endpoints - Neuroimmunological Ancillary Study
    - Cytokine profiles throughout the study.
    - Distribution of T and B cells subpopulations as measured by flow
    cytometry, throughout the study.
    - Levels of neurotrophic and gliotrophic factors (PDGF, NGF, BDNF, and
    eNRG1).
    Safety Endpoints: Safety variables and endpoints will include the
    following:
    - occurrence of adverse events throughout the study
    - vital signs measurements at each visit
    - clinical laboratory test results at screening, and months 1, 3, and 6
    Assessment of Tolerability: Tolerability variables and endpoints are as
    follows:
    -Proportion of patients (%) who prematurely discontinued from the
    study due to adverse events and the time to withdrawal.
    Endpoint di efficacia secondari:
    - Percezione di convenienza misurata in base alla scala di convenienza TSQM-9 nell'arco di 6 mesi di trattamento
    - Variazioni sintomatiche determinate in base alle sottoscale MFIS e MHI di MSQLI nell'arco di 6 mesi di
    trattamento
    - Sintomi della depressione, misurati in base alla scala BDI-II nell'arco di 6 mesi di trattamento

    Endpoint esplorativi:
    - Profili di espressione genica dei pazienti nell'arco di 6 e 12 mesi di trattamento (solo pazienti precedentemente naïve a Copaxone)
    - Associazione tra genetica ed endpoint clinici ed esplorativi selezionati nell'arco di 6 e 12 mesi di trattamento
    - Tasso di ritenzione a 6, 9 e 12 mesi.
    - Aderenza al trattamento, misurata in base alla scala MS-TAQ nell'arco di 6 mesi di trattamento
    - Per pazienti che utilizzano il dispositivo CSYNC, soddisfazione per il dispositivo dopo 1, 6 e 12 mesi di trattamento
    - Valutazione delle variabili chiave a 9 e 12 mesi

    Endpoint - studio neuroimmunologico di supporto
    - Profili delle citochine per tutta la durata dello studio.
    - Distribuzione delle sottopopolazioni di linfociti T e B, misurate mediante citometria a flusso per tutta la durata dello studio.
    - Livelli di fattori neurotrofici e gliotrofici (PDGF, NGF, BDNF, e eNRG1).

    Endpoint di sicurezza: Le variabili e gli endpoint di sicurezza includeranno quanto segue:
    - Manifestazione di eventi avversi per tutta la durata dello studio
    - Misurazione delle funzioni vitali a ogni visita
    - Risultati dei test clinici di laboratorio allo screening e ai mesi 1, 3 e 6

    Valutazione di tollerabilità: Gli endpoint e le variabili di tollerabilità sono i seguenti:
    -Percentuale di pazienti (%) che hanno interrotto prematuramente la partecipazione allo studio a causa di eventi avversi e tempo al ritiro.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary Efficacy Measures:
    - Convenience : months 0, 1, 3, 6, 9, and 12, ETD visit
    - Symptomatic changes: months 0, 1, 3, 6, 9, and 12, ETD visit
    - Depression: months 0, 1, 3, 6, 9, and 12, ETD visit
    Safety Measures:
    - inquiries about adverse events at every visit
    - CBC at screening, and months 1, 3, and 6
    - serum chemistry at screening, months 1, 3, and 6
    - β-hCG in women of child-bearing potential at screening.
    - urine pregnancy test at months 0, 1, 3, 6, 9, and 12, ETD visit
    - vital signs at every visit
    - physical examinations at screening, month 6, 12 and ETD visit
    - inquiries about concomitant medication usage at every visit
    Exploratory and Ancillary Study Measures and Time Points are detailed in
    the study protocol.
    Misure di efficacia secondarie:
    - Praticità: mesi 0, 1, 3, 6, 9 e 12 e visita ETD
    - Variazioni sintomatiche: mesi 0, 1, 3, 6, 9 e 12 e visita ETD
    - Depressione: mesi 0, 1, 3, 6, 9 e 12 e visita ETD
    Misure di sicurezza:
    - Indagini relative agli eventi avversi a ogni visita
    - CBC allo screening e ai mesi 1, 3 e 6
    - Analisi chimica del siero allo screening e ai mesi 1, 3 e 6
    - β-hCG nelle donne in età fertile allo screening.
    - Test di gravidanza sulle urine ai mesi 0, 1, 3, 6, 9 e 12 e alla visita ETD
    - Funzioni vitali a ogni visita
    - Esami obiettivi allo screening, ai mesi 6 e 12 e alla visita ETD
    - Indagini riguardanti l'uso di farmaci concomitanti a ogni visita

    Le misure esplorative e secondarie dello studio e le tempistiche sono esposte nel dettaglio nel protocollo dello studio.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patient medication satisfaction.
    Soddisfazione dei pazienti per il trattamento.
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA68
    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
    Argentina
    Austria
    Belgium
    Croatia
    Germany
    Ireland
    Israel
    Italy
    Mexico
    Russian Federation
    Turkey
    United States
    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
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    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.1.1Number of subjects for this age range: 1
    F.1.1.1In Utero Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 756
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 Yes
    F.3.3.2Women of child-bearing potential using contraception No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 620
    F.4.2.2In the whole clinical trial 840
    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)
    Not applicable.
    Non applicabile.
    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 Decision2015-09-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-05
    P. End of Trial
    P.End of Trial StatusCompleted
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