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    Summary
    EudraCT Number:2010-019028-30
    Sponsor's Protocol Code Number:CFTY720D2320
    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:2010-06-25
    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 number2010-019028-30
    A.3Full title of the trial
    Estudio multicéntrico, aleatorizado, ciego, controlado con placebo de 3 meses de duración para evaluar el efecto del tratamiento con fingolimod en la respuesta inmune después de la vacuna para la gripe estacional y la dosis de recuerdo de vacuna antitetánica en pacientes con formas recidivantes de esclerosis múltiple
    A.4.1Sponsor's protocol code numberCFTY720D2320
    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 SponsorNovartis Farmacéutica, S.A.
    B.1.3.4CountrySpain
    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 nameFTY720
    D.3.2Product code FTY720D
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFingolimod
    D.3.9.1CAS number 162359-56-0
    D.3.9.2Current sponsor codeFTY720
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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 Yes
    D.2.1.1.1Trade name CHIROFLU Suspensión inyectable en jeringa precargada
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS VACCINES AND DIAGNOSTICS S.R.L.
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIRUS GRIPE A H1N1 INACTIVADO HEMAGLUTININA DE
    D.3.9.3Other descriptive nameVIRUS GRIPE A H1N1 INACTIVADO HEMAGLUTININA DE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIRUS GRIPE A H3N2 INACTIVADO HEMAGLUTININA DE
    D.3.9.3Other descriptive nameVIRUS GRIPE A H3N2 INACTIVADO HEMAGLUTININA DE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVIRUS GRIPE B INACTIVADO HEMAGLUTININA DE
    D.3.9.3Other descriptive nameVIRUS GRIPE B INACTIVADO HEMAGLUTININA DE
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) Yes
    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 No
    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 Yes
    D.2.1.1.1Trade name Vacuna no combinada de tétanos Merieux (Tetanus-Impfstoff Merieux )
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Pasteur MSD GmbH
    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 Suspension for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNToxoide tetánico
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number40
    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) Yes
    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 No
    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 placeboCapsule, hard
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Formas recurrentes de esclerosis múltiple
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 13
    E.1.2Level PT
    E.1.2Classification code 10048393
    E.1.2Term Recidiva de esclerosis múltiple
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Es un estudio de investigación clínica para averiguar si el fármaco fingolimod (FTY729) es seguro en personas que padezcan esclerosis múltiple (EM) y que tengan previsto vacunarse contra la gripe estacional, así como recibir la dosis de recuerdo de la vacuna antitetánica.
    E.2.2Secondary objectives of the trial
    Evaluar la respuesta inmune en pacientes que han recibido tratamiento con fingolimod (o placebo) después de una dosis única de la vacuna de la gripe estacional.
    Evaluar la respuesta inmune en pacientes con EM a una dosis única de refuerzo de la vacuna antitetánica.
    [...]
    Para más información, revisar el apartado 2.2 del protocolo.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Los pacientes elegibles para participar en este estudio deberán cumplir todos los criterios que aparecen a continuación:
    1. Se deberá obtener el consentimiento informado antes de que se realice cualquier evaluación del estudio.
    2. Hombres y mujeres con edades comprendidas entre los 18 y 55 años.
    3. Vacuna antitetánica a lo largo de toda la vida.
    4. Pacientes con esclerosis múltiple recidivante.
    5. Pacientes con una puntuación en la Escala Expandida del Estado de Discapacidad (EDSS) de entre 0 y 6,5.
    6. Pacientes que acepten recibir la vacuna de la gripe estacional en el año 2010/11.
    7. Pacientes que acepten recibir la dosis de refuerzo de la vacuna antitetánica.
    E.4Principal exclusion criteria
    Los pacientes que cumplan alguno de los siguientes criterios no podrán ser elegibles para participar en el estudio:
    1. Pacientes con una manifestación de EM distinta a EM recidivante.
    2. Antecedentes de vacunación con la vacuna de la gripe estacional del hemisferio norte de 2010/11 o que tenga programado recibirla fuera de este estudio.
    3. El enfermo ha pasado la gripe confirmada mediante pruebas de laboratorio durante los 6 meses previos a la visita 1.
    4. Antecedentes de vacuna del H1N1 (gripe pandémica A de 2009) o enfermedad confirmada o sospecha de H1N1 durante los 3 meses anteriores al Día 1.
    5. Antecedentes de la dosis de refuerzo de la vacuna antitetánica un año antes de la
    aleatorización.
    6. Antecedentes de anafilaxis o reacción grave después de la administración de cualquier vacuna o hipersensibilidad a los huevos, proteína de huevo, pluma de gallina o a cualquier otro componente de la vacuna o materiales del envase.
    7. Pacientes que hayan sufrido una reacción alérgica a la vacuna antitetánica previa.
    8. Pacientes con antecedentes de enfermedad crónica del sistema inmunitario, que no sea EM o con un síndrome de inmunodeficiencia conocido.
    9. Antecedentes o presencia de cáncer.
    10. Diagnóstico conocido o "nuevo" de diabetes mellitus
    11. Diagnóstico de edema macular durante la fase previa a la aleatorización
    12. Pacientes con infecciones sistémicas activas bacterianas, víricas o fúngicas , o que
    padezcan infección de hepatitis B o hepatitis C.
    13. Resultado negativo del virus varicela-zoster en la selección.
    14. Haber recibido o tener previsto recibir alguna vacuna viva o viva atenuada durante los 2 meses previos al inicio de tomar medicación de estudio o durante el estudio.
    15. Los pacientes que hayan recibido irradiación linfoide total o transplante de médula ósea.
    16. Pacientes que hayan sido tratados con:
    • corticoides u hormonas adrenocorticotrópicas durante el mes previo al inicio de la medicación de estudio;
    • medicación inmunosupresora durante los tres meses previos al inicio de la medicación de estudio;
    • inmunoglobulinas o anticuerpos monoclonales durante los tres meses previos a la aleatorización.
    • cladribina, ciclofosfamida o metoxantrona en cualquier momento.
    17. Pacientes con alguna enfermedad médica no estable, según la evaluación del médico de cada centro
    18 Pacientes que sufran alguna de las siguientes enfermedades cardiovasculares:
    • antecedentes de paro cardíaco;
    • infarto de miocardio en los últimos 6 meses antes de la inclusión o con
    enfermedad cardiaca isquémica inestable actual;
    • insuficiencia cardiaca en el momento de la selección o cualquier enfermedad cardiaca grave determinada por el investigador;
    • antecedentes previos o presencia de bradicardia sintomática;
    • antecedentes o presencia de bloqueo AV de segundo grado o bloqueo AV de tercer grado o un aumento del intervalo QT >450 ms (varones), >470 ms (mujeres) corregido utilizando la fórmula de Bazett en el ECG de visita 1;
    • tratamiento actual con fármacos antiarrítmicos de Clase Ia o de Clase III;
    • frecuencia de pulso en reposo <55 ppm antes del inicio de la medicación de estudio;
    • antecedentes probados de síndrome del seno enfermo o bloqueo cardiaco sinoauricular;
    • antecedentes de prueba de vasculación positiva a partir de un compuesto para el síncope vasovagal;
    antecedentes conocidos de angina de pecho debido a un espasmo coronario o antecedentes de fenómeno Raynaud;
    • hipertensión, no controlada por medicamentos prescritos.
    19. Pacientes que padezcan alguna de las siguientes enfermedades pulmonares:
    • fibrosis pulmonar;
    • tuberculosis activa.
    20. Pacientes que padezcan alguna de las siguientes enfermedades hepáticas:
    • enfermedad hepática crónica o enfermedad biliar;
    • bilirrubina total mayor al límite superior del rango normal, a menos que padezca el síndrome de Gilbert;
    • bilirrubina conjugada mayor al límite superior del rango normal;
    • AST (SGOT), ALT (SGPT) mayor a dos veces el límite superior del rango normal;
    • fosfatasa alcalina mayor a 1,5 veces el límite superior del rango normal;
    • gamma-glutamiltransferasa (GGT) mayor a 3 veces el límite superior del rango normal;
    21. [...]
    Para una información más detallada de todos los criterios de exclusión, ver la sección 4.2. del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la tasa de respondendores a la vacuna de la gripe estacional en Visita 7.

    Para una información más detallada ver la sección 9.4.1 del protocolo adjunto.
    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 Yes
    E.6.13.1Other scope of the trial description
    Immunogenicidad
    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 Yes
    E.8.1.4Double blind No
    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 EEA21
    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 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
    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 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 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 state40
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 120
    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)
    Participación en un estudio de extensión
    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 Decision2010-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-08-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-05-17
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