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The European Union Clinical Trials Register allows you to search for protocol and results information on:
  • interventional clinical trials that are conducted in the European Union (EU) and the European Economic Area (EEA);
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    The EU Clinical Trials Register currently displays   42585   clinical trials with a EudraCT protocol, of which   7011   are clinical trials conducted with subjects less than 18 years old.
    The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely in adults and that are not part of an agreed PIP are not public in the EU CTR (refer to European Guidance 2008/C 168/02   Art. 3 par. 2 and   Commission Guideline 2012/C 302/03,   Art. 5) .

    Clinical Trials marked as "Trial now transitioned" were transitioned to the Clinical Trial Regulation 536/2014 and can be further followed in the Clinical Trial Information System  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2012-005262-35
    Sponsor's Protocol Code Number:16401
    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:2013-06-13
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2012-005262-35
    A.3Full title of the trial
    BENEFIT 11 a long-term, follow-up study (16401) of the BENEFIT (304747), BENEFIT Follow-up (305207) Studies and BENEFIT Extension (311129) Study to further evaluate the progress of patients with first demyelinating event suggestive of multiple sclerosis
    BENEFIT 11, estudio de seguimiento a largo plazo (16401) de los estudios BENEFIT (304747) y de seguimiento de BENEFIT (305207) y del estudio de ampliación de BENEFIT (311129) para seguir evaluando la evolución de pacientes con un primer episodio desmielinizante indicativo de esclerosis múltiple
    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 seguir la evolución de pacientes con síntomas sugestivos de EM que participaron en estudios previos con Betaferon®/Betaseron®
    A.3.2Name or abbreviated title of the trial where available
    BENEFIT 11
    A.4.1Sponsor's protocol code number16401
    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 HealthCare AG
    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 HealthCare AG
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBayer HealthCare AG
    B.5.2Functional name of contact pointBayer Clinical Trials Contact
    B.5.3 Address:
    B.5.3.1Street AddressCTP Team/Ref 'EU CTR'/Bayer Pharma AG
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code13342
    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. name Betaferon 250 microgram/mL, powder and solvent for solution for injection.
    D. of the Marketing Authorisation holderBayer Pharma 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 solvent 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.3.9.4EV 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 clínicamente 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 14.1
    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 14.1
    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 disease course (conversion to clinically-definite multiple sclerosis [CDMS]), change in disability, cognitive function, resource use, and employment status, in relation to treatment with Interferon beta-1b.

    Patients that cannot participate in a physical/face-to-face visit will have the option of being assessed via telephone on selected key outcomes, in an attempt to keep the patient ascertainment as high as possible.
    Los objetivos principales son describir la evolución de la enfermedad (conversión a esclerosis múltiple clínicamente definida [EMCD], el cambio en la discapacidad, la función cognitiva, el uso de recursos y la situación laboral, en relación con el tratamiento con interferón beta-1b

    Los pacientes que no pueden participar en visitas físicas/cara a cara podrán ser evaluados por teléfono con respecto a determinados criterios de valoración
    clave para intentar mantener la verificación de los pacientes en el nivel más alto posible.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to assess magnetic resonance imaging (MRI) and optical coherence tomography (OCT) parameters, treatment history, quality of life (QoL) parameters, fatigue and depression, the choice of MS-specific medication, and to investigate tolerability of Interferon beta-1b in the full former clinically-isolated syndrome (CIS) cohort as well as in subgroups of patients.
    Los objetivos secundarios son evaluar los parámetros de Resonancia Magnética (RM) y tomografía de coherencia óptica (TCO), los antecedentes de tratamiento, los parámetros de calidad de vida (CV), fatiga y depresión, la elección de medicación específica para la EM, y determinar la tolerabilidad de interferón beta-1b en toda la cohorte anterior de pacientes con síndrome clínicamente aislado (SCA) así como en subgrupos de pacientes.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male and female patients with CIS or MS who have been treated at least once in BENEFIT Study 304747.

    2. Patients who do not qualify for one or more interventional assessments (eg, MRI due to severe claustrophobia) are invited to participate in the other assessments of this study.

    3. Written informed consent
    1. Hombres y mujeres con SCA o EM que hayan sido tratados al menos una vez en el estudio BENEFIT 304747

    2. Los pacientes que no cumplen los criterios de una o varias evaluaciones intervencionistas (por ejemplo, RM debido a una claustrofobia grave) están invitados a participar en las otras evaluaciones del estudio

    3. Consentimiento informado por escrito.
    E.4Principal exclusion criteria
    1. Patients who meet any of the following criteria at the time of screening will be excluded from the study:
    _ Patients who, according to the investigator's judgment, have medical, psychiatric, or other conditions that compromise the patient's ability to understand the purpose of the study.

    2. Patients who meet any of the following criteria at the time of screening will be excluded from interventional MRI assessment. However, they should be encouraged to still participate in the study:
    _ Pregnant or nursing (including pumping for storage and feeding).
    _ Contraindications to MRI examination (eg, inability to hold breath, severe arrhythmias, very low cardiac output, severe claustrophobia, or patients with implanted defibrillators or other metallic devices not approved for MRI).

    3. Patients who meet any of the following criteria at the time of screening will be excluded from contrast media administration. However, they may undergo MRI assessment:
    _ Contraindication to the use of gadolinium-containing contrast agents (including patients who are suspected for or known to have nephrogenic systemic fibrosis).
    _ History of severe (as judged by the investigator, taking into account the intensity of the event) allergic or anaphylactoid reaction to any allergen, including drugs and contrast agents.
    _ Received any contrast agent within 72 hours prior to the study MRI, or scheduled to receive any contrast agent within 72 hours after the study MRI.
    _ Renal insufficiency, defined by baseline glomerular filtration rate. Estimated value >= 30 mL/min/1.73 m2 derived from a serum creatinine result within 2 weeks prior to gadolinium-containing contrast agent injection is needed. Any patient on hemodialysis or peritoneal dialysis is excluded from contrast media administration. If there are multiple creatinine values, the values obtained prior to and closest to the time of the MRI should be used. The core lab value should not be used if not available prior to the MRI.
    _ Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or occurring in the perioperative liver transplantation period.
    _ Known history of severe cardiovascular disease (eg, acute myocardial infarction [< 14 days], unstable angina, congestive heart failure New York Heart Association Class IV) or known prolonged QT syndrome.
    _ Suspected clinical instability or unpredictability of the clinical course during the study (eg, due to previous surgery or acute stroke).
    1.Se excluirá del estudio a aquellos pacientes que cumplan cualquiera de los siguientes criterios en el momento de la selección:
    _ Pacientes que, a juicio del investigador, padezcan afecciones médicas, psiquiátricas o de otro tipo que comprometan su capacidad para entender el objetivo del estudio.

    2. Se excluirá de la evaluación mediante RM intervencionista a aquellos pacientes que
    cumplan cualquiera de los siguientes criterios en el momento de la selección. No obstante, se les anima a seguir participando en el estudio:
    _ Embarazo o lactancia (esto incluye la extracción mecánica de leche para darla después al bebé).
    _ Contraindicaciones a la exploración mediante RM (como incapacidad para contener la respiración, arritmias graves, gasto cardiaco muy bajo, claustrofobia grave, o pacientes con desfibriladores u otros dispositivos metálicos implantados no aprobados para RM).

    3. Se excluirá de la administración de medios de contraste a aquellos pacientes que cumplan cualquiera de los siguientes criterios en el momento de la selección. No obstante, pueden someterse a la evaluación mediante RM:
    _ Contraindicación al uso de medios de contraste con gadolinio (incluidos los pacientes con fibrosis sistémica nefrogénica presunta o confirmada).
    _ Antecedentes de reacción alérgica o anafilactoide grave (a juicio del investigador teniendo en cuenta la intensidad del episodio) a algún alérgeno, incluidos fármacos y medios de contraste.
    _ Que hayan recibido un medio de contraste en las 72 horas anteriores a la RM del estudio, o que tengan previsto recibir un medio de contraste en las 72 horas posteriores a la RM del estudio.
    _ Insuficiencia renal, definida por la filtración glomerular inicial. Se necesita un valor estimado >= 30 ml/min/1,73 m2 derivado de un resultado de creatinina sérica en las 2 semanas anteriores a la inyección de un medio de contraste que contenga gadolinio.
    No se podrá administrar el medio de contraste a los pacientes sometidos a hemodiálisis o diálisis peritoneal. Si hay varios valores de creatinina, se usarán los obtenidos con anterioridad y más cerca del momento de la RM. El valor del laboratorio central no se usará si no está disponible antes de la RM.
    _ Insuficiencia renal aguda de cualquier intensidad, ya sea debida a síndrome
    hepatorrenal o que se produzca en el periodo perioperatorio de un trasplante de hígado.
    _ Antecedentes confirmados de cardiovasculopatía grave (p. ej., infarto agudo de miocardio [< 14 días], angina inestable, insuficiencia cardiaca congestiva de clase IV según la New York Heart Association) o síndrome de QT prolongado confirmado.
    _ Sospecha de inestabilidad clínica o impredictibilidad de la evolución clínica durante el estudio (por ejemplo, debido a cirugía previa o accidente cerebrovascular agudo).
    E.5 End points
    E.5.1Primary end point(s)
    Regular face-to-face site visit:
    -Conversion to CDMS, to MS by McDonald criteria (2001, 2010), and / or to secondary progressive multiple sclerosis (disease course)
    -Expanded Disability Status Scale (EDSS) including DSS 3 and 6 information, Multiple Sclerosis Functional Composite (MSFC) (disability and disability progression) and Multiple Sclerosis Severity Score (MSSS)
    -Paced Auditory Serial Addition Test (PASAT) and Symbol Digit Modalities Test (SDMT) (cognitive function)
    -Resource use and employment status

    Telephone assessment for patients unable to visit site with selected outcomes:
    -Telephone EDSS
    -Conversion to CDMS (disease course)
    -Resource use and vocational status
    -Choice of and adherence to MS-specific medication
    -Center of Epidemiological Studies Depression Scale (CES-D) (depression)
    -Fatigue Scale for Sensory and Motor Functions (FSMC) (fatigue)
    - Functional Assessment of Multiple Sclerosis (FAMS) and European Quality of Life - 5 Dimensions (EQ-5D) (QoL)
    Visita regular personal al centro
    -Conversión a EMCD, a EM según los criterios de McDonald (2001,2010), o a esclerosis múltiple secundaria progresiva (curso de la enfermedad)
    -Escala ampliada del estado de discapacidad (EDSS), que incluye información de las escalas DSS 3 y 6, escala funcional compuesta para la esclerosis múltiple (MSFC) (discapacidad y evolución de la discapacidad) y puntuación de la gravedad de la esclerosis múltiple (MSSS)
    -Test de 3 segundos de adición auditiva seriada en pasos y test de símbolos y dígitos (función cognitiva)
    -Uso de recursos y situación laboral

    Evaluación telefónica para pacientes que no pueden acudir al centro con criterios de valoración seleccionados
    -EDSS telefónico [6]
    -Conversión a EMCD (curso de la enfermedad)
    -Uso de recursos y situación laboral
    -Elección de la medicación específica para la EM y cumplimiento terapéutico
    -CES-D (depresión)
    -FSMC (fatiga) 5
    -FAMS, EQ-5D (Calidad de Vida)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Relapses, disease course, EDSS milestones and medication history - retrospective assessment since subject's last visit in any of the previous BENEFIT studies up to 11 years.

    Resource use - retrospective baseline assessment and 11 year visit.

    Cognitive function, depression, fatigue, QoL - cross-sectional assessment (only or in addition to a retrospective assessment) at approximately 11 years after randomization.

    Please refer to Figure 4.2 in the Protocol for full details of assessments for the different endpoints in this study.
    Recaídas, curso de la enfermedad, diferentes EDSS y antecedentes de medicación- Evaluación retrospectiva desde la última visita del paciente en cualquiera de los estudios BENEFIT anteriores hasta 11 años.

    Uso de recursos- evaluación inicial retrospectiva y visita año 11.

    Función cognitiva, depresión, fatiga, Calidad de Vida-evaluación transversal ( sola o como complemento de una evaluación retrospectiva) aproximadamente 11 años después de la aleatorización.

    Véase imagen 4.2 del Protocolo para información detallada de la evaluación de los diferentes criterios de valoración del estudio.
    E.5.2Secondary end point(s)
    Regular face-to-face site visit:
    -Diagnosis and disease course
    -MRI parameters
    -OCT parameters
    -Visual acuity and ophthalmological findings
    -CES-D (depression)
    -FSMC (fatigue)
    -Choice of and adherence to MS-specific medication
    -FAMS and EQ-5D (QoL)
    -Deoxyribonucleic acid [DNA], ribonucleic acid [RNA], biomarkers
    -Vitamin D
    Visita regular personal al centro
    -Diagnóstico y curso de la enfermedad
    -Parámetros de RM
    -Parámetros de TCO
    -Agudeza visual y hallazgos oftalmológicos
    -Escala del centro de estudios epidemiológicos para la depresión (CES-D) (depresión)
    -Escala de fatiga de funciones motoras y cognitivas (fatiga)
    -Elección de la medicación específica para la EM y cumplimiento
    -Evaluación funcional de la esclerosis múltiple (FAMS) y cuestionario europeo sobre calidad de vida de 5 dimensiones (EQ-5D) (CV)
    - Ácido desoxirribonucleico [ADN], ácido ribonucleico [ARN],biomarcadores
    - Vitamina D
    E.5.2.1Timepoint(s) of evaluation of this end point
    Disease course and medication history - retrospective assessment since subject's last visit in any of the previous BENEFIT studies up to 11 years.

    MRI, OCT, depression, fatigue, QoL, genetics, evaluation of biomarkers and vitamin D - cross-sectional assessment (only or in addition to a retrospective assessment) at approximately 11 years after randomization.

    Please refer to Figure 4.2 in the Protocol for full details of assessments for the different endpoints in this study.
    Evolución de la enfermedad y antecedentes de medicación - Evaluación retrospectiva desde la última visita del paciente en cualquiera de los estudios BENEFIT hasta 11 años.

    MRI, TCO, depresión, fatiga, calidad de vida, genética, evaluación de los biomarcadores y vitamina D - evaluación transversal (solo o como complemento a una evaluación retrospectiva) aproximadamente 11 años tras la aleatorización.

    Véase imagen 4.2 en el Protocolo, para información detallada de evaluación para los diferentes criterios de valoración del estudio.
    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. 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 EEA84
    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
    Czech Republic
    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
    Última visita de último paciente
    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 months10
    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 months10
    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: 468
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-06-13. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women Yes
    F.3.3.4Nursing women Yes
    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 state46
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 425
    F.4.2.2In the whole clinical trial 468
    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.
    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 Decision2013-06-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2014-04-28
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