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    The EU Clinical Trials Register currently displays   44293   clinical trials with a EudraCT protocol, of which   7351   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).

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    Summary
    EudraCT Number:2008-006333-27
    Sponsor's Protocol Code Number:105MS301
    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:2009-07-02
    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 number2008-006333-27
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, doble ciego, con grupos paralelos y controlado con placebo para evaluar la eficacia y la seguridad del interferón beta-1a pegilado (BIIB017) en sujetos con esclerosis múltiple recidivante.

    A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects with Relapsing Multiple Sclerosis.
    A.3.2Name or abbreviated title of the trial where available
    ADVANCE
    A.4.1Sponsor's protocol code number105MS301
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 nameInterferón Beta-1a pegilado
    D.3.2Product code BIIB017
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeInterferón beta-1a
    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 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 nameInterferón Beta-1a pegilado
    D.3.2Product code BIIB017
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number63
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeInterferón Beta-1a
    D.IMP: 3
    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 nameInterferón Beta-1a pegilado
    D.3.2Product code BIIB017
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    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 number94
    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) Information not present in EudraCT
    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 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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 typeInterferón 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
    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
    Esclerosis múltiple recidivante

    Relapsing Multiple Sclerosis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10028245
    E.1.2Term Multiple sclerosis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal de este estudio es determinar la eficacia de BIIB017 para reducir la tasa anual de recidivas (TAR) en sujetos con EMR después de un año.
    E.2.2Secondary objectives of the trial
    Los objetivos secundarios de este estudio son determinar si BIIB017 después de un año, en comparación con un placebo, es eficaz para:
    - Reducir el número total de lesiones hiperintensas en T2 nuevas o que han incrementado en las RMN cerebrales.
    - Reducir el porcentaje de sujetos que han experimentado una recidiva.
    - Mejorar la calidad de vida conforme a la puntuación física de la escala de impacto de la esclerosis múltiple de 29 ítems (MSIS-29).
    - Retrasar la progresión de la discapacidad basada en un aumento de al menos 1,0 puntos en la escala ampliada del estado de discapacidad (EDSS, Expanded Disability Status Scale) con respecto a un valor basal EDSS ? 1,0 que se mantenga durante doce 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 doce semanas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Para poder participar en este estudio, los candidatos deberán cumplir los criterios de elegibilidad siguientes en el momento de la aleatorización (día 1):
    1. Capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado por escrito, firmando y fechando el documento correspondiente, así como de autorizar la utilización de información sanitaria confidencial conforme a la legislación nacional y local de confidencialidad de los datos del paciente.
    2. Edad de 18 a 55 años, inclusive, en el momento de dar el consentimiento informado.
    3. Deben tener un diagnóstico confirmado de EM recidivante, definida conforme a los criterios de McDonald 1-4 .
    4. Deben tener una puntuación entre 0,0 y 5,0 en la escala EDSS.
    5. Deben haber experimentado al menos dos recidivas, documentadas médicamente, en los tres últimos años, y al menos una de estas recidivas debe haber ocurrido en los doce meses previos a la aleatorización (día 1).
    6. Todos los sujetos varones y las mujeres 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
    No podrán entrar si alguno de los siguientes criterios de exclusión se cumple en el momento de la aleatorización (día 1):
    1. EM primaria progresiva, secundaria progresiva o progresiva recidivante (conforme a definiciones de Lublin y Reingold, 1996) con un empeoramiento clínico continuo de la enfermedad durante un período de 3 meses como mínimo.
    2. Antecedentes de reacciones alérgicas o anafilácticas intensas o hipersensibilidad conocida.
    3. El tratamiento previo con interferón no puede ser superior a 4 semanas y los sujetos deben haber interrumpido el tratamiento con interferón 6 meses antes de la visita basal.
    4. Alergia conocida a cualquier componente de la formulación de BIIB017.
    5. Antecedentes de enfermedades cardíacas, endocrinas, hematológicas, hepáticas, inmunológicas, metabólicas, urológicas, pulmonares, neurológicas, dermatológicas, psiquiátricas y renales o de otras enfermedades importantes clínicamente significativas (conforme al criterio del investigador) y que impedirían la participación en un ensayo clínico.
    6. Antecedentes de neoplasias malignas, incluidos tumores sólidos y neoplasias malignas hematológicas (excepto carcinomas basocelulares y espinocelulares cutáneos extirpados completamente y que se consideren curados).
    7. Antecedentes de epilepsia o desmayos no explicados O antecedentes de una crisis convulsiva en los 3 meses anteriores al período basal.
    8. Antecedentes de ideas suicidas en los 3 meses previos al período basal o episodio de depresión grave en los 3 meses previos al período basal. Se define depresión grave como un episodio de depresión que requiere hospitalización, o según el criterio del investigador.
    9. Valores anormales clínicamente significativos en el ECG según el criterio del investigador.
    10. Antecedentes conocidos o un resultado positivo en la prueba del VIH.
    11. Resultado positivo en la prueba del VHC (prueba de Ab anti-VHC) o del VHB (prueba del HBsAg y/o de HBcAb).
    12. Pruebas hematológicas anormales que superen cualquiera de los límites definidos a continuación, en el período de selección:
    - Niveles de ALT/SGPT más de 2 veces el límite superior de la normalidad (> 2 x LSN) o AST/SGOT > 2 x LSN o bilirrubina > 1,5 x LSN.
    - Recuento total de leucocitos < 3.700/mm3.
    - RAN < 1.500/mm3.
    - Recuento de plaquetas < 150.000/mm3.
    - Hemoglobina < 10 g/dl en mujeres; < 11 g/dl en varones.
    - Creatinina sérica > LSN.
    - TP o TTPa > 1,2 x LSN.
    13. Recidiva de la EM que ha ocurrido en los 50 días previos a la aleatorización y/o el sujeto no se ha estabilizado después de una recidiva previa antes de la aleatorización (día 1).
    Antecedentes de tto.:
    14. Cualquier tto. previo con BIIB017.
    15. Antecedentes de hipersensibilidad o intolerancia al acetaminofén (paracetamol), ibuprofeno, naproxeno o aspirina que impedirían el uso de al menos 1 de estos fármacos durante el estudio.
    16. Tto. con otros fármacos para tratar los síntomas de la EM o una enfermedad subyacente como se especifica en la tabla pág. 40:
    17. Tto. con otro fármaco en investigación o con un tto. aprobado para uso en investigaciones en los 6 meses previos a la aleatorización (día 1).
    Otros criterios
    18. Mujeres que estén considerando la posibilidad de quedarse embarazadas durante el período del estudio.
    19. No podrán participar en este estudio mujeres en edad fértil con prueba de embarazo positiva en la visita de selección o en la visita del día 1 (visita basal).
    20. Mujeres embarazadas o en periodo de lactancia.
    21. Antecedentes de toxicomanías o alcoholismo (conforme al criterio del investigador) en los 2 años previos al día 1.
    22. Incapacidad para realizar la prueba de recorrido cronometrado de 7,6 metros (25 pies), la 9HPT con los 2 miembros superiores y la prueba PASAT 3.
    23. Incapacidad para realizar pruebas de función visual.
    24. Sujetos en los que la RMN esté contraindicada: pacientes con marcapasos u otros dispositivos metálicos implantados contraindicados, que sean alérgicos al gadolinio o que padezcan claustrofobia no controlable médicamente.
    25. Participación actual en cualquier otro estudio con un fármaco en investigación.
    26. Participación previa en este estudio.
    27. Cirugía programada realizada en las 2 semanas previas a la aleatorización (día 1) o programada durante el período del estudio.
    28. 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.
    29. 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)
    La variable principal de este estudio es determinar la eficacia de BIIB017 para reducir la tasa anual de recidivas (TAR) en sujetos con EMR al año
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Inmunogenicidad
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 EEA170
    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
    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
    Última visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 1000
    F.4.2.2In the whole clinical trial 1260
    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)
    Como se establece en el protocolo
    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 Decision2009-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-07-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-10-24
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