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    Summary
    EudraCT Number:2010-020515-37
    Sponsor's Protocol Code Number:CFTY720D2399
    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:2010-08-02
    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 number2010-020515-37
    A.3Full title of the trial
    Estudio multicéntrico, abierto, de un único grupo que evalúa la seguridad y tolerabilidad a largo plazo de fingolimod 0,5 mg (FTY720) administrado por vía oral una vez al día en pacientes con formas recidivantes de esclerosis múltiple
    A.4.1Sponsor's protocol code numberCFTY720D2399
    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 nameFingolimod
    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 codeFTY720D
    D.3.9.3Other descriptive nameFTY720
    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.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
    Esclerosis Múltiple Remitente Recurrente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.1
    E.1.2Level LLT
    E.1.2Classification code 10048393
    E.1.2Term Multiple sclerosis relapse
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Este estudio esta diseñado para evaluar la seguridad y la tolerabilidad a largo plazo de una dosis de 0,5 mg de fingolimod administrada una vez al día en pacientes con formas recidivantes de EM.
    E.2.2Secondary objectives of the trial
    Este estudio también evaluará la eficacia a largo plazo en pacientes con formas recidivantes de EM en tratamiento con 0,5 mg/día de fingolimod.
    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 por escrito antes de que se realice cualquier evaluación.

    2. Pacientes que hayan completado los ensayos con fingolimod designados actualmente en curso o previstos.
    E.4Principal exclusion criteria
    Los pacientes que cumplan alguno de los siguientes criterios no podrán ser elegibles para participar en el estudio:

    1. Discontinuación prematura permanente de un estudio previo con fingolimod debido a:

    a. Un acontecimiento adverso o acontecimiento adverso grave o anomalía de laboratorio, salvo embarazo.

    b. Condiciones que lleven a la discontinuación permanente del fármaco del estudio como por ejemplo, edema macular, elevación de las enzimas hepáticas cinco veces superior al LSN (límite superior normal), cáncer en cualquier sistema orgánico. En el Anexo 5: Pautas para la Monitorización de Seguridad se ofrece una descripción completa de estos criterios de exclusión y de las directrices de monitorización.

    2. Mujeres embarazadas o en periodo de lactancia, donde embarazo se define como el estado de una mujer después de la concepción y hasta la finalización de la gestación, confirmado por un resultado positivo de hCG en la prueba analítica (>5 mUI/ml).

    3. Mujeres potencialmente fértiles, definidas como toda mujer fisiológicamente capaz de quedarse embarazada, incluidas las mujeres cuya profesión, estilo de vida u orientación sexual impida la relación sexual con una pareja masculina y mujeres cuyas parejas hayan sido esterilizadas por vasectomía u otros métodos, A MENOS que estén utilizando dos métodos anticonceptivos, al menos uno de ellos debe ser un método anticonceptivo principal. Véase el apartado 6.5.8. para una información más detallada. Según el criterio del investigador, la abstinencia total en cuanto a relaciones sexuales se acepta en los casos en los que la edad, profesión, estilo de vida u orientación sexual de los pacientes garanticen la prevención del embarazo.
    Las mujeres se considerarán post-menopáusicas y no potencialmente fértiles si han tenido 12 meses de amenorrea natural (espontánea) con un perfil clínico apropiado (p. ej., edad adecuada, antecedentes de síntomas vasomotores) ó 6 meses de amenorrea espontánea con niveles de FSH en suero > 40 mUI/ml o se les ha practicado una ooforectomía bilateral (con o sin histerectomía) en las últimas 6 semanas antes de la visita basal. En el caso de que solo se le haya practicado una ooferoctomía, únicamente cuando se haya confirmado el estado reproductor de la mujer mediante una evaluación de seguimiento del nivel de hormonas, ésta se considerará como no potencialmente fértil.

    4. Pacientes con antecedentes de enfermedad crónica del sistema inmunitario, que no sea EM o que puedan requerir tratamiento inmunosupresor.

    5. Pacientes diabéticos con retinopatía diabética no proliferativa moderada o grave o una retinopatía diabética proliferativa y pacientes diabéticos no controlados con HbA1c > 8%.

    6. Pacientes con infecciones sistémicas activas bacterianas, víricas o fúngicas, o que padezcan SIDA, hepatitis B, hepatitis C o que tengan anticuerpos positivos del VIH , antígeno de superficie de la hepatitis B positivo o pruebas de anticuerpos de la hepatitis C.

    7. Tratamiento previo con cladribina, ciclofosfamida o mitoxantrona.

    8. Tratamiento con inmunoglobulinas o anticuerpos monoclonales (incluido natalizumab) durante los últimos tres meses del estudio previo con fingolimod.

    9. Cualquier enfermedad médica no estable que pueda interferir en la capacidad del paciente para cooperar y cumplir con los procesos del estudio, según la evaluación del médico que le trate.

    10. Pacientes que sufran alguna de las siguientes enfermedades cardiovasculares que se hayan desarrollado durante el estudio previo con fingolimod:

    a. infarto de miocardio en los últimos 6 meses antes de la inclusión en el estudio de extensión o con enfermedad cardiaca isquémica inestable actual;

    b. insuficiencia cardiaca (Clase III, según la clasificación de la New York Heart Association) o cualquier enfermedad cardiaca grave determinada por el investigador;

    c. arritmia que requiera el tratamiento actual con fármacos antiarrítmicos de Clase III (p. ej., amiodarona, bretilio, sotalol, ibulitida, azimilida y dofelitida);

    d. antecedentes o presencia de un bloqueo AV de tercer grado;

    e. antecedentes probados de síndrome del seno enfermo o bloqueo cardiaco sinoauricular;

    f. antecedentes conocidos de angina de pecho debido a un espasmo coronario o antecedentes de fenómeno Raynaud.

    11. Pacientes que hayan padecido alguna de las siguientes enfermedades pulmonares durante el estudio previo con fingolimod:

    a. enfermedad respiratoria grave o diagnóstico de fibrosis pulmonar (durante el estudio previo con fingolimod)

    b. tuberculosis activa.

    12. Abuso de alcohol, enfermedad hepática crónica durante el estudio previo con fingolimod.
    E.5 End points
    E.5.1Primary end point(s)
    Los datos de los acontecimientos adversos (AA), de laboratorio, de las constantes vitales, de ECG y de las evaluaciones oftalmológicas y cutáneas se utilizarán para evaluar el objetivo principal.
    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 Yes
    E.6.13.1Other scope of the trial description
    Calidad de vida relacionada con la salud.
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA500
    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
    Se considerará que un paciente ha finalizado el estudio cuando fingolimod esté comercializado y le sea reembolsado en el país pertinente o cuando un paciente se retire del estudio por cualquier motivo y haya finalizado la visita de finalización del estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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 months8
    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 state181
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 3000
    F.4.2.2In the whole clinical trial 5000
    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 Decision2010-10-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-10-08
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-10-19
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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