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    Summary
    EudraCT Number:2017-001176-31
    Sponsor's Protocol Code Number:19215
    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:2021-01-20
    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 number2017-001176-31
    A.3Full title of the trial
    BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT followup
    studies
    Studio BENEFIT 15 di follow-up a lungo termine degli studi BENEFIT e BENEFIT follow-up
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A long term follow up study to look at the progress of patients with symptoms suggestive of MS who took part in previous studies with Betaferon¿/Betaseron¿
    Uno studio di follow-up a lungo termine per esaminare il progresso dei pazienti con
    Sintomi suggestivi di SM che hanno partecipato a studi precedenti con Betaferon¿ / Betaseron¿
    A.3.2Name or abbreviated title of the trial where available
    NA
    NA
    A.4.1Sponsor's protocol code number19215
    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 SponsorBAYER AG
    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 supportBAYER AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBAYER AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityBerlino
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number00
    B.5.5Fax number00
    B.5.6E-mailclinical-trials-contact@bayer.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 Betaferon 250 microgram/ml, power and solvent for solution for injection
    D.2.1.1.2Name of the Marketing Authorisation holderBAYER AG
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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 Powder and solvent for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINTERFERONE BETA 1B
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB39502
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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
    Clinically-isolated syndrome (CIS) and multiple sclerosis (MS)
    Sclerosi multipla (MS), e CIS (Sindrome Clinicamente Isolata),
    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 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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10071068
    E.1.2Term Clinically isolated syndrome
    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 objectives are to describe the course of disease over time including, relapse, disability, cognitive function) and the healthcare
    resource utilization (HRU) (resource use, employment status), in relation to treatment with IFNB-1b.
    Gli obiettivi primari sono descrivere il decorso della malattia nel tempo (incluse recidiva, disabilit¿, funzionalit¿ cognitiva) e l'utilizzo di risorse sanitarie (Healthcare Resource Utilization, HRU) (utilizzo di risorse e stato occupazionale) in relazione al trattamento con IFNB-1b
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess MRI, treatment history and current MS-specific medication, quality of life (QoL), fatigue, and
    depression, in the full former clinically-isolated syndrome (CIS) cohort as well as in subgroups of subjects.
    Gli obiettivi secondari sono valutare la RM, l'anamnesi farmacologica e l'attuale trattamento specifico per la sclerosi multipla (Multiple Sclerosis, MS), la qualit¿ di vita (QoL), l'affaticamento e la depressione nell¿intera prima coorte della sindrome clinicamente isolata (Clinically-Isolated Syndrome, CIS), come pure nei sottogruppi di soggetti.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.All subjects who were treated at least once in BENEFIT study 304747 are eligible for inclusion in the BENEFIT 15 study. Also, those original
    BENEFIT subjects who prematurely discontinued study participation in any of the prior BENEFIT studies are eligible for inclusion in the BENEFIT
    15 study.
    2.Subjects with signed written informed consent
    1) Tutti i soggetti che sono stati trattati almeno una volta nello studio BENEFIT 304747 sono idonei a essere inclusi nello studio BENEFIT 15. Anche quei soggetti dello studio BENEFIT originale che hanno interrotto in anticipo la partecipazione allo studio in uno qualsiasi dei precedenti studi BENEFIT sono idonei a essere inclusi nello studio BENEFIT 15.
    2) soggetti che hanno firmato il consenso informato
    E.4Principal exclusion criteria
    1.Subjects who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the subject's ability to
    understand the purpose of the study;
    2.Subjects who meet any of the following criteria will only be excluded from the MRI assessment. However, these subjects should be encouraged to nevertheless participate in the clinical part of the study;
    3.Pregnant or nursing (including pumping for storage and feeding)
    4.Contraindications to MRI examination (e.g., inability to hold breath,
    severearrhythmias, very low cardiac output, severe claustrophobia, or
    subjects with implanted defibrillators or other metallic devices not
    approved for MRI)
    5.Suspected clinical instability or unpredictability of the clinical course
    during the study (e.g., due to previous surgery or acute stroke)
    1. I soggetti che, secondo la valutazione del ricercatore, hanno condizioni mediche, psichiatriche o altre condizione che compromettono la capacità del soggetto di comprendere lo scopo dello studio
    2. I oggetti che soddisfano uno dei seguenti criteri verranno esclusi dalla valutazione della Risonanza Magnetica. Tuttavia, questi soggetti dovrebbero essere incoraggiati a partecipare comunque alla parte clinica dello studio:
    3. sei incinta o in allattamento (compreso il tiraggio per conservazione e alimentazione )
    4. Contraindicazioni alla Risonanza Magnetica (MRI) (ad esempio, incapacità di trattenere il respiro,
    gravi aritmie, insufficienza cardiaca molto bassa, claustrofobia severa o Soggetti con defibrillatori impiantati o altri dispositivi metallici non
    consentiti dalla Risonanza);
    5.Sospetta instabilità clinica o imprevedibilità del corso clinico durante lo studio (ad esempio, a causa di un precedente intervento chirurgico o di ictus acuto)
    E.5 End points
    E.5.1Primary end point(s)
    As this is a long-term follow-up, the study is purely exploratory and
    descriptive in nature. Accordingly, a primary variable has not been
    selected.
    In order to describe disease course over time, the following efficacy
    variables of primary interest will be used:
    - Diagnosis and disease course according to McDonald Criteria
    (2001,2010)
    - Time to relapse (first, recurrent, annualized rate)
    - Time to conversion to CDMS
    - Time to conversion to SPMS
    - Disability (EDSS score)
    - Disability progression (confirmed and sustained 1-point EDSS
    progression;
    - confirmed 2.5-point EDSS progression)
    - Neurological status (Multiple Sclerosis Functional Composite (MSFC)
    score)
    - Cognitive function (MSFC: PASAT-3 score)
    - Time to use of ambulatory device
    - Time to dependence on ambulatory device
    - Time to use of wheelchair
    In order to describe resource use and employment status (primary study
    objective), the following HRU-based efficacy variables of primary
    interest will be used:
    - Employment status and MS impact on employment
    - Resource use: hospitalizations, visits to other specialists, and
    supportive care.
    Poiché questo è un follow-up a lungo termine, lo studio è puramente esplorativo e di natura Descrittiva. Di conseguenza, una variabile primaria non è stata
    selezionata.
    Al fine di descrivere il decorso della malattia nel tempo saranno utilizzate le seguenti variabili di efficacia di interesse primario:
    • Diagnosi e decorso della malattia secondo i criteri McDonald (2001,2010)
    • Tempo alla recidiva (prima, ricorrente, tasso annualizzato)
    • Tempo alla conversione a sclerosi multipla definita clinicamente
    • Tempo alla conversione a sclerosi multipla secondaria progressiva
    • Disabilità (punteggio EDSS)
    Progressione della disabilità (progressione con EDSS = 1 punto confermata e prolungata; progressione con EDSS = 2,5 punti confermata)
    • Stato neurologico (punteggio MSFC, Multiple Sclerosis Functional Composite)
    • Funzionalità cognitiva (punteggio MSFC: PASAT-3)
    • Tempo all'utilizzo di un deambulatore
    • Tempo alla dipendenza da un deambulatore
    • Tempo all'utilizzo di una sedia a rotelle
    Al fine di descrivere l’uso di risorse e lo stato occupazionale (obiettivo primario dello studio), saranno utilizzate le seguenti variabili di efficacia basate sull'utilizzo di risorse sanitarie (HRU) di interesse primario:
    • Stato occupazionale e impatto della MS sull'attività lavorativa
    • Utilizzo di risorse: ricoveri, visite presso altri specialisti e terapia di supporto
    E.5.1.1Timepoint(s) of evaluation of this end point
    All data will be collected at a single clinical and MRI assessment visit, 15
    years after the subject's first clinical event. The assessments can be
    done at different time points where needed for logistic reasons.
    Tutti i dati saranno acquisiti durante una sola visita di valutazione clinica e della RM, 15 anni dopo il primo evento clinico del soggetto. Le valutazioni possono essere eseguite in diversi momenti, quando necessario per ragioni logistiche.
    E.5.2Secondary end point(s)
    Secondary variables of interest will be:
    - Sustained attention, concentration, and information-processing speed
    (SDMT scores)
    - Relation of SDMT and FSMC
    - Relation of mental processing speed and MRI parameters.
    In order to assess QoL, fatigue, and depression (secondary study
    objectives), the following patient reported outcomes (PRO) will be used:
    - QoL (EQ-5D score, FAMS score)
    - Fatigue (FSMC score)
    - Depression (CES-D score).
    In order to describe MS-specific medication (secondary study objective),
    the following variables will be used:
    - Time to second line therapy
    - Time to first disease-modifying therapies (DMT) other than IFNB-1b
    The following other efficacy variables will be used:
    - MRI parameters: T1 lesion number and volume, cerebral volume
    - BMs Time to CDMS, to McDonald MS (diagnostic criteria 2001, 2010),
    and / or to SPMS
    Le variabili secondarie di interesse saranno:
    - attenzione costante, concentrazione e velocit¿ di elaborazione delle informazioni (punteggi SDMT)
    - Relazione di SDMT e FSMC
    - Rapporto di velocit¿ di elaborazione mentale e parametri RM
    Allo scopo di valutare la QoL, la stanchezza e la depressione (obiettivi econdari dello studio), verranno utilizzati i seguenti risultati del paziente (PRO):
    - QoL (punteggio EQ-5D, punteggio FAMS)
    - Fatica (punteggio FSMC)
    - Depressione (punteggio CES-D).
    Al fine di descrivere il farmaco specifico per MS (obiettivo di studio secondario)
    Verranno utilizzate le seguenti variabili:
    - Tempo per la seconda linea di terapia
    Tempo per le prime terapie che modificano le malattie (DMT) diverse da IFNB-1b
    Saranno utilizzate le seguenti variabili di efficacia:
    - parametri MRI: numero e volume della lesione T1, volume cerebrale
    - BMs Time to CDMS, McDonald MS (criteri diagnostici 2001, 2010) e / o SPMS
    E.5.2.1Timepoint(s) of evaluation of this end point
    All data will be collected at a single clinical and MRI assessment visit, 15
    years after the subject's first clinical event. The assessments can be
    done at different time points where needed for logistic reasons
    Tutti i dati saranno cquisiti durante una sola visita di valutazione clinica e della RM 15 anni dopo il primo evento clinico del soggetto. Le valutazioni possono essere eseguite in diversi momenti, quando necessario per ragioni logistiche
    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 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 trial0
    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 concerned5
    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
    Canada
    Israel
    Austria
    Belgium
    Czechia
    Denmark
    Finland
    Germany
    Hungary
    Italy
    Norway
    Poland
    Slovenia
    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
    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 months7
    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 months7
    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: 300
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 276
    F.4.2.2In the whole clinical trial 300
    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)
    NA
    NA
    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 Decision2017-11-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-11
    P. End of Trial
    P.End of Trial StatusCompleted
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