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    Summary
    EudraCT Number:2010-024477-39
    Sponsor's Protocol Code Number:105MS302
    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:2011-06-28
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2010-024477-39
    A.3Full title of the trial
    A Dose-Frequency Blinded, Multicenter, Extension Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
    Un estudio de extensión multicéntrico de frecuencia de dosis ciego, para determinar la seguridad y eficacia a largo plazo del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Determine the Long-Term Safety and Efficacy of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis
    Un estudio para determinar la seguridad y eficacia a largo plazo del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.
    A.3.2Name or abbreviated title of the trial where available
    ATTAIN
    A.4.1Sponsor's protocol code number105MS302
    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 Limited
    B.1.3.4CountryUnited Kingdom
    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 Idec Limited
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationBiogen Idec Limited
    B.5.2Functional name of contact pointNot Available at this time
    B.5.3 Address:
    B.5.3.1Street AddressInnovation House, 70 Norden Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 4AY
    B.5.3.4CountryUnited Kingdom
    B.5.6E-mailATTAINstudy@biogenidec.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 No
    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 nameInterferon Beta 1a pegilado
    D.3.2Product code BIIB017
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInterferón beta 1a
    D.3.9.2Current sponsor codeBIIB017
    D.3.9.3Other descriptive nameInterferón beta 1a pegilado
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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 Yes
    D.3.11.13.1Other medicinal product typeInterferon Beta-1a
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection/infusion in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing Multiple Sclerosis
    Esclerosis múltiple recidivante.
    E.1.1.1Medical condition in easily understood language
    Relapsing Multiple Sclerosis
    Esclerosis múltiple recidivante.
    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 14.0
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    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 evaluate the long-term safety and tolerability of BIIB017 in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.
    El objetivo principal de este estudio es evaluar la seguridad y tolerabilidad a largo plazo de BIIB017 en sujetos tratados originalmente en el estudio 105MS301 que continúan el tratamiento con BIIB017.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are to describe long-term MS outcomes in subjects originally treated in Study 105MS301 who continue BIIB017 treatment.
    Los objetivos secundarios de este estudio son describir los resultados de EM a largo plazo en sujetos tratados originalmente en el estudio 105MS301 que continúan el tratamiento con BIIB017.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
    2. Subjects who participated in Study 105MS301, who completed the study treatment and visit schedule through Week 96.
    3. Subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 3 months after their last dose of study treatment.
    1. Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado, firmando y fechando el documento correspondiente, así como de autorizar la utilización de información sanitaria protegida (ISP) conforme a la legislación nacional y local de confidencialidad de los datos del paciente.

    2. Los sujetos que hayan participado en el estudio 105MS301 y hayan completado el tratamiento del estudio y el calendario de visitas hasta la semana 96.

    3. Los sujetos con capacidad de procrear deben utilizar un método anticonceptivo eficaz durante el estudio y estar dispuestos a continuar su uso durante tres meses después de la última dosis del tratamiento del estudio.
    E.4Principal exclusion criteria
    1. Subjects exceeding more than 6 weeks since completion of the Week 96 visit of Study 105MS301.
    2. Subjects with any significant change in medical history, including laboratory tests, or a current clinically significant condition that in the opinion of the Investigator would have excluded the subject from participation in Study 105MS301. The Investigator must re-review the subject's medical fitness for participation and consider any factors that would preclude treatment including:
    - Presence of any clinically significant (as determined by the Investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary,neurologic, dermatologic, psychiatric, renal, or other major disease that would preclude participation in a clinical study.
    - Presence of malignant disease, including solid tumors and hematologic malignancies (with the exception of basal cell and squamous cell carcinomas of the skin that have been completely excised and are considered cured).
    - Clinically significant laboratory abnormalities (hematology and blood chemistry) on the most recently available test of Study 105MS301, as determined by the Investigator. Laboratory findings mandating discontinuation of study treatment as defined in protocol 105MS301 are exclusionary.
    3. Female subjects who are currently pregnant (as reflected by a positive pregnancy test at the Week 96 Visit of Study 105MS301/Baseline Visit), who are currently breastfeeding, or who are considering becoming pregnant while in the study.
    4. Unwillingness or inability to comply with the requirements of the protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject?s ability to comply with the protocol.
    5. Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.
    1. Los sujetos para los que hayan transcurrido más de 6 semanas desde la finalización de la visita de la semana 96 en el estudio 105MS301.

    2. Los sujetos que tengan cualquier cambio significativo en su historia clínica, incluidas las pruebas de laboratorio, o una afección actual clínicamente significativa que, en la opinión del investigador, habría excluido al sujetos de participar en el estudio 105MS301. El investigador debe volver a determinar si el sujeto está médicamente apto para participar y considerar cualquier factor que podría impedir el tratamiento, incluidos: Presencia de cualquier enfermedad cardíaca, endocrina, hematológica, hepática, inmunológica, metabólica, urológica, pulmonar, neurológica, dermatológica, psiquiátrica, renal u otra enfermedad importante que sea clínicamente significativa (conforme al criterio del investigador) y que impediría la participación en un ensayo clínico. Presencia de una neoplasia maligna, incluidos tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y espinocelulares de la piel que hayan sido extirpados completamente y se consideren curados). Resultados anormales de las pruebas de laboratorio (hematología y bioquímica) clínicamente significativos en la prueba más reciente disponible del estudio 105MS301, conforme al criterio del investigador. Los hallazgos de laboratorio para los que es obligatorio interrumpir el tratamiento del estudio que se definen en el protocolo 105MS301 son excluyentes.

    3. Las mujeres que estén actualmente embarazadas (que hayan tenido un resultado positivo en la prueba de embarazo de la visita de la semana 96 del estudio 105MS301/ visita basal), que estén actualmente en período de lactancia o que estén considerando la posibilidad de quedarse embarazadas durante el del estudio.

    4. Negativa o imposibilidad de cumplir los requisitos del protocolo, incluida la presencia de cualquier circunstancia (física, mental o social) que pueda afectar a la capacidad del sujeto para cumplir el protocolo.

    5. Cualquier otro motivo no especificado que, en opinión del investigador o de Biogen Idec, haga al sujeto no adecuado para el reclutamiento.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints include the incidence of AEs, serious AEs (SAEs), and discontinuations of study treatment due to an AE, as well as the incidence of laboratory abnormalities.
    Los criterios de valoración incluyen la incidencia de AA, AAG y las interrupciones del tratamiento del estudio debidas a un AA, así como la incidencia de resultados anormales de laboratorio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As Necessary
    Según sea necesario.
    E.5.2Secondary end point(s)
    Relapse outcomes:
    The annualized relapse rate (ARR)
    The proportion of subjects who relapse
    MRI outcomes:
    The total number of new or newly enlarging T2 hyperintense lesions on brain MRI
    scans
    The number of new active lesions on brain MRI scans
    The total number of new T1 hypointense lesions on brain MRI scans
    The number of Gadolinium (Gd)-enhancing lesions on brain MRI scans
    The volume of T2 hyperintense lesions on brain MRI scans
    The volume of T1 hypointense lesions on brain MRI scans
    The volume of Gd-enhancing lesions on brain MRI scans
    Whole brain atrophy
    Disability outcomes:
    The degree of disability as measured by the EDSS
    Disability progression (as measured by at least a 1.0 point increase on the EDSS from baseline EDSS > = 1.0 that is sustained for 24 weeks, or at least a 1.5 point increase on the EDSS from baseline EDSS = 0 that is sustained for 24 weeks).
    Cognitive function as reflected by the SDMT
    Quality of Life outcomes:
    The MSIS-29 physical score
    The SF-12
    The Euro Quality of Life (EQ-5D)
    Other outcomes:
    The number of relapses requiring intravenous (IV) steroid use
    The number of MS-related hospitalizations
    Percent of subject-reported treatment satisfaction
    Resultados de recidivas:
    - La tasa anualizada de recidivas (TAR)
    - Proporción de sujetos con recidiva
    Resultados de RM:
    - El número total de lesiones hiperintensas en T2 nuevas o que han crecido en las RM cerebrales
    - El número de nuevas lesiones activas en las RM cerebrales
    - El número total de lesiones hipointensas en T1 nuevas en las RM cerebrales
    - El número de lesiones realzadas con gadolinio (Gd) en las RM cerebrales
    - El volumen de las lesiones hiperintensas en T2 en las RM cerebrales
    - El volumen de las lesiones hipointensas en T1 en las RM cerebrales
    - El volumen de las lesiones realzadas con Gd en las RM cerebrales
    - Atrofia cerebral total
    Resultados de discapacidad:
    - El grado de discapacidad medido con la escala EDSS
    - Progresión de la discapacidad (medida por un aumento de al menos 1,0 puntos en la escala EDSS con respecto al valor basal de EDSS > = 1,0 que se mantenga durante veinticuatro semanas, o un aumento de al menos 1,5 puntos en la escala EDSS con respecto a un valor basal = 0 que se mantenga durante veinticuatro semanas)
    - Función cognitiva medida con la SDMT.
    Resultados de la calidad de vida:
    - Puntuación física de la escala MSIS-29
    - El SF-12
    - El cuestionario EuroQoL de calidad de vida (EQ-5D).
    Otros resultados:
    - El número de recidivas que requieren el uso de esteroides intravenosos (i.v.)
    - El número de hospitalizaciones relacionadas con la EM
    - Porcentaje de satisfacción con el tratamiento informada por los sujetos
    E.5.2.1Timepoint(s) of evaluation of this end point
    As Necessary
    Según sea necesario.
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA99
    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
    Belgium
    Bulgaria
    Canada
    Chile
    Colombia
    Croatia
    Czech Republic
    Estonia
    France
    Germany
    Greece
    India
    Latvia
    Mexico
    Netherlands
    New Zealand
    Peru
    Poland
    Romania
    Russian Federation
    Serbia
    Spain
    Ukraine
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    LPLV
    Última visita del último paciente.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    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 years4
    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.1.1Number of subjects for this age range: 0
    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: 1495
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 708
    F.4.2.2In the whole clinical trial 1600
    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)
    Expected Normal Treatment
    Tratamiento normal esperado.
    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 Decision2011-08-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-10-01
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