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    Summary
    EudraCT Number:2015-002201-11
    Sponsor's Protocol Code Number:BIIT0215
    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:2016-09-28
    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 number2015-002201-11
    A.3Full title of the trial
    Multicenter interventional Phase IV study for the assessment of the effects on patient’s satisfaction of Plegridy (pre-filled pen) in subjects with relapsing-remitting multiple sclerosis unsatisfied with other injectable subcutaneous Interferons. PLATINUM STUDY
    Studio multicentrico interventistico di fase IV per la valutazione dell’effetto di Plegridy (penna preriempita) sulla soddisfazione in pazienti con Sclerosi Multipla recidivante-remittente insoddisfatti del trattamento con altri interferoni iniettabili sottocute. Studio PLATINUM.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study for the satisfaction assessement of the treatment with Plegridy in patient with Multiple Sclerosis
    Studio per la valutazione della soddisfazione dei pazienti con Sclerosi Multipla all'utilizzo del farmaco Plegridy.
    A.3.2Name or abbreviated title of the trial where available
    PLATINUM
    PLATINUM
    A.4.1Sponsor's protocol code numberBIIT0215
    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 SponsorBIOGEN IDEC ITALIA S.R.L.
    B.1.3.4CountryItaly
    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 supportBiogen Italia srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Italia srl
    B.5.2Functional name of contact pointDirezione Medica
    B.5.3 Address:
    B.5.3.1Street AddressVia G. Spadolini 5
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number025849901
    B.5.5Fax number0258499131
    B.5.6E-mailelisa.puma@biogen.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 PLEGRIDY - 125 MCG - SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIEMPITA - 0,5 ML - 6 PENNE PRERIEMPITE
    D.2.1.1.2Name of the Marketing Authorisation holderBIOGEN IDEC 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.3.1Product namePlegridy
    D.3.2Product code L03AB13
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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
    Subjects with relapsing-remitting multiple sclerosis
    Pazienti affetti da Sclerosi Multipla recidivante-remittente
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Sclerosi Multipla
    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 19.0
    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 the study is to investigate whether Peg-IFN beta-1a improves patients’ satisfaction in RRMS subjects unsatisfied with other injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM-9), across a 12-weeks observation period.
    Valutare se il trattamento con Peg-IFN beta-1a migliora la soddisfazione correlata alla convenience del paziente affetto da RRMS, insoddisfatto della terapia con altri interferoni iniettabili sottocute, misurata mediante il questionario Abbreviated Treatment Satisfaction Questionnaire to Medication (TSQM- 9) somministrato a 12 settimane di trattamento con Peg-IFN.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study consist in the evaluation, in this study population, of the following parameters:
    •effects of Peg-IFN beta-1a treatment on patients’ satisfaction at 24 weeks;
    •effects of Peg-IFN beta-1a treatment on short-term patients’ adherence;
    •impact of Peg-IFN beta-1a treatment on patient-reported health-related quality of life;
    •effects of Peg-IFN beta-1a treatment on patients’ fatigue;
    •impact of Peg-IFN beta-1a treatment on patients’ injection-system satisfaction;
    •effects of Peg-IFN beta-1a on disease activity and physical disability;
    •relationship between patients’ satisfaction and adherence;
    •relationship between patients’ satisfaction and social-demographic factors (age, sex, employment working, level of education, etc) and clinical characteristics (ARR, disability, etc.)
    •Valutare gli effetti del trattamento con Peg-IFN beta-1a
    -sulla soddisfazione generale del paziente al trattamento a 24 settimane;
    -sulla aderenza al trattamento a breve termine;
    -sulla fatigue percepita dal paziente;
    -sulle ricadute e sulla disabilità fisica del paziente;

    •Valutare l’impatto del trattamento con Peg-IFN beta-1a
    -sulla qualità di vita del paziente;
    -sulla soddisfazione del paziente nei confronti del sistema di iniezione utilizzato;

    •Valutare la correlazione tra la soddisfazione del paziente e l'aderenza al trattamento;

    •Valutare la correlazione tra la soddisfazione del paziente e fattori socio-demografici (età, sesso, occupazione, livello di istruzione, ecc) e caratteristiche cliniche (tasso annualizzato di recidive (ARR), livello di disabilità,).

    •Valutare la tollerabilità al trattamento e la sicurezza.

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    18 < Age < 65 years
    RRMS as per 2010 McDonald criteria
    Baseline EDSS between 0.0 and 5.0
    Treatment with injectable subcutaneous Interferons with score < 58 in the “convenience satisfaction” domain of TSQM-9
    Signed informed consent
    Period of stability from last relapse of at least 30 days before the baseline visit.
    Treatment with intravenous corticosteroids completed at least 30 days before the baseline visit (assumption of oral cortisone allowed as long as within 4 mg per day for no longer than 3 days).
    -Età ≥ 18 e ≤65 anni;
    -Diagnosi di Sclerosi multipla recidivante-remittente secondo i criteri McDonald (2010);
    -Stato di disabilità secondo la scala (EDDS) con punteggio compreso tra 0.0 e 5.0;
    -Punteggio del questionario TSQM9 nel dominio della convenienza < 58 relativamente al trattamento in corso con interferoni iniettabili sottocute;
    - Consenso informato firmato;
    - Periodo di stabilità dall'ultima ricaduta di almeno 30 giorni prima della visita basale;
    -Trattamento con corticosteroidi per via endovenosa completato almeno 30 giorni prima della visita basale (l’assunzione di cortisone orale è consentita fino a 4 mg al giorno per non più di 3 giorni).
    E.4Principal exclusion criteria
    Pregnancy or breast-feeding
    Depression or other psychiatric disorders
    Unwillingness or inability to comply with the protocol requirements
    Any contra-indications to treatment with Peg-IFN-beta 1a according to the Summary of Product Characteristics
    Gravidanza o allattamento;
    -Depressione o altre patologie psichiatriche;
    -Indisponibilità o incapacità a seguire le procedure previste dal protocollo a giudizio del medico;
    - Eventuali controindicazioni al trattamento con interferone beta-1a secondo quanto riportato nel Riassunto delle Caratteristiche del Prodotto.

    E.5 End points
    E.5.1Primary end point(s)
    Changes from baseline in the score of convenience satisfaction domain of TSQM-9 at 12 weeks
    Variazione del punteggio relativo al dominio sulla convenience del questionario TSQM-9 a 12 settimane rispetto al basale
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks
    12 settimane
    E.5.2Secondary end point(s)
    Changes from baseline in the score of all domains of TSQM-9 at 24 weeks; -Changes from baseline in clinical measures (ARR, percentage of relapse-free patients, EDSS) measures at week 24. -Incidence and severity of adverse events occurred during the study (including local tolerance to treatment at the injection site). -Abnormalities in laboratory values.
    -Variazione del punteggio di tutti i domini del questionario TSQM-9 a 24 settimane rispetto al basale; -Variazione delle caratteristiche cliniche (ARR, percentuale di pazienti liberi da recidiva, EDSS) a 24 settimane rispetto al basale; -Incidenza e gravità degli Eventi Avversi avvenuti durante lo studio (inclusa la tollerabilità locale al trattamento nel sito di iniezione); -Anormalità dei parametri di laboratorio.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    24 settimane
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Patient satisfaction and life-quality
    Grado di soddisfazione del paziente e qualità della vita
    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 concerned35
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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 years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months6
    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: 275
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    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 state275
    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)
    At the end of the study, responding patients will continue the drug under study, as indication of the Investigator.
    I pazienti che rispondono positivamente alla terapia al termine dello studio continueranno ad assumere il farmaco oggetto di studio, a discrezione dello sperimentatore
    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 Decision2015-10-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
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