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    Summary
    EudraCT Number:2017-001176-31
    Sponsor's Protocol Code Number:19215
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-07-12
    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 number2017-001176-31
    A.3Full title of the trial
    BENEFIT 15 long-term follow-up study of the BENEFIT and BENEFIT follow-up studies
    BENEFIT 15 Estudio de seguimiento a largo plazo del estudio BENEFIT y de los estudios de seguimiento de BENEFIT
    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®
    Estudio de seguimiento a largo plazo para observar el progreso de los pacientes con síntomas sugestivos de EM que participaron en estudios previos con Betaferon® / Betaseron®
    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 AddressN/A
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    B.5.3.4CountryGermany
    B.5.4Telephone number0034.900 102372
    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, powder 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 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 nameBetaferon
    D.3.4Pharmaceutical form Powder and solution for solution for injection
    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 INNRECOMBINANT INTERFERON BETA-1B
    D.3.9.2Current sponsor codeBAY86-5046
    D.3.9.3Other descriptive nameRECOMBINANT INTERFERON BETA-1B
    D.3.9.4EV Substance CodeSUB39502
    D.3.10 Strength
    D.3.10.1Concentration unit µg/ml microgram(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 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 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)
    Síndrome clínico aislado (SCA) y esclerosis múltiple (EM)
    E.1.1.1Medical condition in easily understood language
    Multiple sclerosis (MS)
    Esclerosis múltiple (EM)
    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 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.
    Los objetivos principales son describir la evolución de la enfermedad a lo largo del tiempo (incluidas las recidivas, la discapacidad y la función cognitiva), así como la utilización de recursos sanitarios o URS (uso de recursos, situación laboral) en relación con el tratamiento 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.
    Los objetivos secundarios son evaluar la resonancia magnética (RM), el historial de tratamiento y la medicación actual específica para la EM, la calidad de vida (CdV), la fatiga y la depresión en la antigua cohorte completa del síndrome clínico aislado (SCA), así como en subgrupos de sujetos.
    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 areeligible for inclusion in the BENEFIT 15 study.
    2.Subjects with signed written informed consent
    1. Todos los sujetos tratados al menos una vez en el estudio BENEFIT 304747 son elegibles para su inclusión en el estudio BENEFIT 15. Asimismo, los sujetos del estudio BENEFIT original que interrumpieron de forma prematura su participación en cualquiera de los estudios BENEFIT anteriores son elegibles para su inclusión en el estudio BENEFIT 15.
    2. Sujetos que hayan firmado el consentimiento informado
    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. Los sujetos que, según el criterio del investigador, tienen condiciones médicas, psiquiátricas u otras que comprometan la capacidad del sujeto para entender el propósito del estudio
    2. Los sujetos que cumplan cualquiera de los siguientes criterios solo serán excluidos de la evaluación de MRI. Sin embargo, estos sujetos deben ser alentados a participar en la parte clínica del estudio:
    3. Embarazo o lactancia (incluyendo bombeo para almacenamiento y alimentación)
    4. Contraindicaciones para el examen de resonancia magnética (por ejemplo, la incapacidad de mantener la respiración, arritmias severas, muy bajo rendimiento cardíaco, claustrofobia severa, o los sujetos con desfibriladores implantados u otros dispositivos metálicos no aprobados para la RM)
    5. Inestabilidad clínica predecible o imprevisibilidad del curso clínico durante el estudio (por ejemplo, debido a cirugía previa o accidente cerebrovascular agudo)
    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.
    Como se trata de un seguimiento a largo plazo, el estudio es puramente de naturaleza exploratoria y descriptiva. En consecuencia, no se ha seleccionado una variable principal.

    Para describir el curso de la enfermedad a lo largo del tiempo, se utilizarán los siguientes criterios de valoración de la eficacia de interés principal:
    - Diagnóstico y curso de la enfermedad según los Criterios de McDonald (2001,2010)
    - Tiempo hasta la recaída (primera, recurrente, tasa anualizada)
    - Tiempo hasta la conversión a esclerosis múltiple definitiva según criterios clínicos
    - Tiempo hasta la conversión a esclerosis múltiple progresiva secundaria
    - Discapacidad (puntuación en la escala EDSS)
    - Progresión de la discapacidad (progresión confirmada y mantenida de 1 punto en la escala EDSS; progresión confirmada de 2,5 puntos en la escala EDSS)
    - Estado neurológico (puntuación en la escala funcional compuesta para la esclerosis múltiple, MSFC)
    - Función cognitiva (puntuación MSFC: PASAT-3)
    - Tiempo hasta la utilización de un dispositivo para deambulación
    - Tiempo hasta la dependencia del dispositivo para deambulación
    - Tiempo hasta la utilización de silla de ruedas

    A fin de describir el empleo de recursos y la situación laboral (objetivo principal del estudio) se usarán las siguientes variables de interés primario relativas a la eficacia en cuanto a utilización de recursos sanitarios (URS):
    - Situación laboral e impacto de la EM en la situación laboral
    - Empleo de recursos: hospitalizaciones, visitas a otros especialistas y tratamiento sintomático.
    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.
    Todos los datos se recopilarán en una única visita de evaluación clínica y mediante RM, 15 años después del primer episodio clínico del sujeto. Las pruebas se pueden realizar en momentos diferentes cuando así se precise por motivos logísticos.
    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
    Las variables secundarias serán:
    - Atención sostenida, concentración y velocidad de procesamiento de la información (puntuación SDMT)
    - Relación de SDMT y FSMC
    - Relación de velocidad de procesamiento mental y parámetros de MRI.

    Para evaluar la CdV, la fatiga y la depresión (objetivos secundarios del estudio), se utilizarán los siguientes resultados informados por el paciente (RIP):
    - CdV (puntuación EQ-5D, puntuación FAMS)
    - Fatiga (puntuación FSMC)
    - Depresión (puntuación CES-D).

    Para describir la medicación específica de la EM (objetivo del estudio secundario), se utilizarán las siguientes variables:
    - Tiempo hasta la terapia de segunda línea
    - Tiempo hasta las primeras terapias modificadoras de la enfermedad (TME) distintas de IFNB-1b

    Se utilizarán las siguientes otras variables de eficacia:
    - Parámetros de RM: número y volumen de la lesión T1, volumen cerebral
    - BMs Tiempo hasta CDMS, a McDonald MS (criterios de diagnóstico 2001, 2010), y / o a 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.
    Todos los datos se recopilarán en una única visita de evaluación clínica y mediante RM, 15 años después del primer episodio clínico del sujeto. Las pruebas se pueden realizar en momentos diferentes cuando así se precise por motivos logísticos.
    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 Yes
    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.8.3 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 concerned7
    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 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
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    Germany
    Hungary
    Israel
    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
    UVUP
    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 state36
    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)
    Not Applicable
    No Aplicable
    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 Decision2017-09-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-05-24
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