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    Summary
    EudraCT Number:2017-005129-18
    Sponsor's Protocol Code Number:PROMISE
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:
    Date on which this record was first entered in the EudraCT database:2018-03-26
    Trial 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 number2017-005129-18
    A.3Full title of the trial
    Multi-centre, randomised, open label pragmatic trial to compare the effectiveness and safety of interferon beta-1a (IFN-beta-1a) weekly i.m. and glatiramer-acetate (GA) in paediatric patients affected by multiple sclerosis.
    Studio pragmatico, multicentrico, randomizzato, in aperto per confrontare l'efficacia e la sicurezza dell'interferone beta-1a (IFN beta-1a) settimanale i.m. e glatiramer-acetato (GA) in pazienti pediatrici affetti da sclerosi multipla
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Clinical trial to evaluate the effectiveness and safety of IFN beta-1a (IFN beta-1a), injected once a week via intramuscolar (i.m.), and glatiramer-acetate (GA) in children/adolescent patients with multiple sclerosis.
    Studio clinico per confrontare efficacia e sicurezza dell'interferone beta-1a (IFN beta-1a), somministrato una volta a settimana nel muscolo, e glatiramer-acetato (GA) in pazienti pediatrici affetti da sclerosi multipla.
    A.4.1Sponsor's protocol code numberPROMISE
    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 SponsorUniversità degli Studi Aldo Moro
    B.1.3.4CountryItaly
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAIFA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversità degli Studi Aldo Moro
    B.5.2Functional name of contact pointLucia Margari
    B.5.3 Address:
    B.5.3.1Street AddressPiazza Giulio Cesare, 11
    B.5.3.2Town/ cityBari
    B.5.3.3Post code70124
    B.5.3.4CountryItaly
    B.5.4Telephone number+390805592829
    B.5.5Fax number+390805595260
    B.5.6E-maillucia.margari@uniba.it
    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 40 mg/ml solution for injection, pre-filled syringe
    D.2.1.1.2Name of the Marketing Authorisation holderTeva Pharmaceuticals Ltd
    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 Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGlatiramer Acetate
    D.3.9.1CAS number 147245-92-9
    D.3.9.3Other descriptive nameGLATIRAMER ACETATE
    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 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.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 AVONEX 30 µg/0,5 ml solution for injection
    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.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferon beta-1a
    D.3.9.1CAS number 145258-61-3
    D.3.9.3Other descriptive nameINTERFERON BETA-1A
    D.3.9.4EV Substance CodeSUB12440MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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-remitting multiple sclerosis with paediatric onset
    Sclerosi multipla ad esordio pediatrico con forma recidivante-remittente (RR)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis in children and adolescents aged up to 17 years wth relapsing-remitting course
    Sclerosi multipla ad insorgenza in età inferiore ai 17 anni con forma recidivante-remittente (RR)
    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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The main objective of the study is to demonstrate the equivalence of two of injectable drugs (IFN beta 1a 30-mcg im weekly and GA 40 mg s.c. e.o.d.) currently used for the treatment of POMS or the superiority of one of them on MRI and clinical effectiveness outcomes.
    Confrontare la sicurezza (frequenza e tipo di eventi avversi) e l'efficacia (attraverso misure di risonanza magnetica) tra l'IFN-beta 1a settimanale i.m. e GA in POMS con forma recidivante-remittente (RR).
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare safety and cost-effectiveness of the two drugs.
    Confrontare l'efficacia dell’IFN-beta 1a e GA sul tasso annuale di recidive (ARR), su outcome cognitivi, comportamentali e riportati dal paziente (PRO).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Diagnosis of POMS [23,24]
    • Male and female children and adolescents aged between 10 to 17 years included at the time of informed consent (i.e. have not yet had their 18th birthday at randomization);
    • Treatment naïve;
    • Signed and dated informed consent from parents/legal representative;
    • Relapsing remitting course;
    • At least one MS relapse during the previous year;
    • EDSS score of 0 to 5.5, inclusive
    • Subjects of childbearing potential who are sexually active must be willing to practice effective contraception during the study.
    • Diagnosi di Sclerosi Multipla Pediatrica (secondo i criteri di Krupp e colleghi 2013);
    • Bambini e adolescenti di età compresa tra 10 e 17 anni inclusi al momento della firma del consenso informato (ovvero che non hanno ancora raggiunto il loro diciottesimo compleanno alla randomizzazione)
    • Naïve al trattamento;
    • Consenso informato datato e firmato dai genitori/rappresentante legale;
    • Decorso di malattia recidivante-remittente;
    • Presenza di almeno una ricaduta nell’anno precedente;
    • Punteggio di disabilità (EDSS score) compreso tra 0 e 5.5 incluso;
    • I soggetti in età fertile che sono sessualmente attivi devono essere disposti a praticare contraccettivi efficaci durante lo studio.
    E.4Principal exclusion criteria
    • Patients with progressive MS;
    • Patients with an active, chronic disease of the immune system other than MS;
    • Patients meeting the definition of Acute Disseminated Encephalomyelitis (ADEM);
    • Patients with thyroid dysfunction;
    • Patients with severe renal insufficiency
    • Pazienti con Sclerosi Multipla progressiva;
    • Pazienti con una malattia cronica attiva del sistema immunitario diversa dalla SM;
    • Pazienti che soddisfano la definizione di Encefalomielite acuta disseminata (ADEM);
    • Pazienti con disfunzione tiroidea;
    • Pazienti con insufficienza renale grave.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects free of new or newly enlarging T2 hyperintense on brain MRI scans at 96 weeks.
    Proporzione di soggetti liberi da lesioni T2 iperintense nuove o in allargamento nell’ MRI celebrale a 96 settimane
    E.5.1.1Timepoint(s) of evaluation of this end point
    As above
    Come sopra
    E.5.2Secondary end point(s)
    Efficacy endpoints:
    • Annualized relapse rate (ARR) at Weeks 48 and 96;
    • Proportion of subjects free of relapse up to Week 96;
    • Time to first relapse;
    • Time to disability progression defined as 1-point increase of the Expanded Disability Status Scale (EDSS) score confirmed at Week 24;
    • Number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Weeks 48 and 96;
    • Number of MRI T1 Gd-enhancing lesions on brain MRI scans at Weeks 48 and 96;
    • Change of Symbol Digit Modality test (SDMT) at Weeks 48 and 96;
    • Change of Fatigue (FS) score at Weeks 48 and 96;
    • Change of QOL (ped QOL) evaluated through Patient Reported Outcomes (PROs) at Weeks 48 and 96;
    • Cost-efficacy analyses. An estimate of the cost-effectiveness of the therapeutic regimens under examination.

    Safety endpoint:
    • Frequency and type of Adverse Events (AEs) during all the study
    Endpoint di efficacia:
    • Frequenza Annuale di recidive (ARR) a 48 e 96 settimane;
    • Proporzione di soggetti liberi da recidive fino alla 96 settimana;
    • comparsa della prima recidiva;
    • comparsa di progressione della disabilità definita come aumento di 1 punto della Expanded Disability Status Scale (EDSS) confermato alla settimana 24;
    • Numero di lesioni T2 iperintense nuove o in allargamento nell’ MRI celebrale alla settimana 48 e 96;
    • Numero di lesioni T1 Gd-enhancing alla MRI celebrale alla settimana 48 e 96;
    • Variazioni del Symbol Digit Modality Test (SDMT) alla settimana 48 e 96;
    • Variazione del Fatigue (FS) score alla settimana 48 e 96;
    • Variazione del QOL (ped QOL) valutato attraverso il Patient Reported Outcomes (PROs) alla settimana 48 e 96;
    • Analisi costo-efficacia. Una stima del costo-efficacia del regime terapeutico sotto esame.

    Endpoint di Sicurezza: Frequenza e tipo di Evento Avverso (AEs) durante tutto lo studio
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above
    Come sopra
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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) Yes
    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 concerned19
    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
    Study end is defined as the database lock
    La fine dello studio è sancita dalla chiusura del database.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 142
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 10
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 132
    F.1.2Adults (18-64 years) No
    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 state142
    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)
    It is possible to continue with the study drug after the clinical study is finished, if patient has received a good benefit in terms of reduced disease recurrence and therefore better clinical control, according to clinical practice.
    E’ possibile continuare con il farmaco in studio dopo la conclusione dello studio clinico, se il paziente ha ricevuto beneficio in accordo con le pratiche cliniche ospedaliere.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Network per la Ricerca Clinica Pediatrica (INCiPiT)
    G.4.3.4Network Country Italy
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-06-26
    N.Ethics Committee Opinion of the trial application
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion
    P. End of Trial
    P.End of Trial Status
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