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    Summary
    EudraCT Number:2011-005280-24
    Sponsor's Protocol Code Number:CFTY720I2201
    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:2012-08-07
    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 number2011-005280-24
    A.3Full title of the trial
    A double-blind, randomized, multicenter, placebo-controlled, parallel-group study to evaluate the efficacy and safety of 0.5 mg fingolimod administered orally once daily versus placebo in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
    Estudio doble ciego, aleatorizado, multicéntrico, controlado con placebo, de grupos paralelos para evaluar la eficacia y la seguridad de fingolimod 0,5 mg administrado por vía oral una vez al día en comparación con placebo en pacientes con polirradiculoneuropatía desmielinizante inflamatoria crónica (PDIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Evaluate efficacy and safety of fingolimod 0.5 mg orally once daily versus placebo in chronic inflammatory demyelinating
    polyradiculoneuropathy
    Evaluar la eficacia y la seguridad de fingolimod 0,5 mg administrado por vía oral una vez al día en comparación con placebo en la polirradiculoneuropatía desmielinizante inflamatoria crónica
    A.4.1Sponsor's protocol code numberCFTY720I2201
    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 SponsorNovartis Pharma Services AG
    B.1.3.4CountrySwitzerland
    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 supportNovartis Pharma Services AG
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPPD
    B.5.2Functional name of contact pointProject Manager
    B.5.3 Address:
    B.5.3.1Street Address45-47 Blvd Paul Vaillant Couturier
    B.5.3.2Town/ cityIvry-Sur-Seine Cedex
    B.5.3.3Post code94853
    B.5.3.4CountryFrance
    B.5.4Telephone number+33467402887
    B.5.5Fax number+441223899740
    B.5.6E-mailkim.dawe@ppdi.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 Yes
    D.2.1.1.1Trade name GILENYA 0,5 mg cápsulas duras
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    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 Yes
    D.2.5.1Orphan drug designation numberEU/3/09/718
    D.3 Description of the IMP
    D.3.1Product namefingolimod
    D.3.2Product code FTY720I
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    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.3.9.3Other descriptive nameHIDROCLORURO DE FINGOLIMOD
    D.3.9.4EV Substance CodeSUB30967
    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) 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 No
    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
    Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP)
    Polirradiculoneuropatía desmielinizante inflamatoria crónica (PDIC)
    E.1.1.1Medical condition in easily understood language
    Chronic inflammatory demyelinating polyneuropathy (CIDP)
    Polineuropatía desmielinizante inflamatoria crónica (PDIC)
    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 10057645
    E.1.2Term Chronic inflammatory demyelinating polyradiculoneuropathy
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the effect of fingolimod 0.5 mg daily compared with placebo on delaying disability progression, in patients with CIDP, measured by the time to the first confirmed worsening on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale. A confirmed worsening is defined as an increase by 1 point or more on the adjusted INCAT Disability Scale from the value at Baseline.
    Evaluar el efecto del tratamiento con fingolimod 0,5 mg/día, en comparación con placebo, en cuanto al retraso de la progresión de la discapacidad en pacientes con PDIC, determinado mediante el tiempo transcurrido hasta el primer episodio de empeoramiento confirmado en la Escala de discapacidad de causa y tratamiento de la neuropatía inflamatoria (INCAT) ajustada. Se considera empeoramiento confirmado el aumento de un punto o más, con respecto al valor basal, en la escala de discapacidad INCAT ajustada.
    E.2.2Secondary objectives of the trial
    - to assess the change in grip strength from Baseline to Month 6/End-of-Treatment (whichever occurs first) in CIDP patients on fingolimod as compared with those on placebo
    - to assess the change in Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS) from Baseline to Month 6/End-of-Treatment (whichever occurs first) in CIDP patients on fingolimod as compared with those on placebo
    - to evaluate safety and tolerability of fingolimod compared with placebo in patients with CIDP
    - Evaluar la variación de la fuerza de prensión desde el momento basal hasta el mes 6/final del tratamiento (lo que ocurra antes) en los pacientes con PDIC tratados con fingolimod en comparación con los tratados con placebo.
    - Evaluar la variación de la Escala de discapacidad general ponderada linealmente elaborada y según el modelo de Rasch (R-ODS, Rasch-Built Linearly Weighted Overall Disability Scale) desde el momento basal hasta el mes 6/final del tratamiento (lo que ocurra antes) en los pacientes con PDIC tratados con fingolimod en comparación con los tratados con placebo.
    - Evaluar la seguridad y la tolerabilidad del fingolimod en comparación con placebo en pacientes con PDIC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria
    1. written informed consent must be obtained before any assessment is performed
    2. Either confirmed diagnosis of typical CIDP as defined by the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) Task Force First Revision Or one of the following forms of atypical CIDP: - pure motor CIDP - MADSAM
    (Lewis-Sumner syndrome) - CIDP in association with MGUS IgG or IgA but not IgM MGUS
    3. disability defined by an INCAT Disability Scale score of 1-9 or, if INCAT score is 0, a
    documented history of disability sufficient to
    require treatment within the past 2 years
    following reduction or interruption of CIDP
    treatment
    4. receiving IVIg treatment (minimal
    dose equivalent to 0.4 g/kg every 4 weeks) or corticosteroids (minimal dose equivalent to prednisone 10 mg/day) treatment prior to the screening visit
    5. history of relapsing or progressive clinical course upon interruption or reduction of therapies within 1 year prior to Screening
    6. male or female, aged 18 years or older at Screening
    1. Deberá obtenerse el consentimiento informado antes de realizar cualquier evaluación.
    2. Diagnóstico confirmado de PDIC típica según la definición de la primera revisión del grupo de trabajo de la EFNS/PNS
    o bien una de las siguientes variantes atípicas de PDIC:
    - PDIC motora pura.
    - MADSAM (síndrome de Lewis-Sumner).
    - PDIC asociada a GMSI de tipo IgG o IgA, pero no a GMSI de tipo IgM.
    3. Discapacidad, definida por una puntuación de 1 a 9 en la Escala de discapacidad INCAT o, si la puntuación de esta última es 0, por antecedentes documentados de discapacidad suficiente como para necesitar tratamiento en los dos últimos años tras una reducción o interrupción del tratamiento de la PDIC.
    4. Estar en tratamiento con IgIV (dosis mínima equivalente a 0,4 g/kg cada 4 semanas) o corticoesteroides (dosis mínima equivalente a 10 mg de prednisona/día) antes de la visita de selección.
    5. Antecedentes de recidiva o evolución clínica progresiva al interrumpir o reducir el tratamiento en el año anterior a la visita de selección.
    6. Varones o mujeres de 18 años o mayores en el momento de la selección.
    E.4Principal exclusion criteria
    Exclusion Criteria
    1. other chronic demyelinating neuropathies, including: - Distal Acquired Demyelinating Symmetric Neuropathy (DADS) - Multifocal Motor Neuropathy with conduction block (MMN) - pure sensory CIDP - hematopoietic malignancy except for MGUS IgG or IgA
    2. conditions in which the pathogenesis of the neuropathy may be different from CIDP such as: Lyme disease, POEMS syndrome, osteosclerotic myeloma, Castleman's
    disease
    3. treatment with: - plasma exchange
    within 2 months of randomization -
    immunosuppressive/chemotherapeutic
    medications: - azathioprine, cyclophosphamide, cyclosporine, mycophenolate, etanercept, methotrexate within 6 months of randomization -
    Rituximab in the 2 years prior to randomization - other immunosuppressive medications (including mitoxantrone, alemtuzumab, cladribine) at any time - hematopoietic stem cell transplantation at any time
    4. a CIDP relapse or significant worsening of symptoms within 2 months of randomization.
    Criterios de exclusión:
    1. Otras neuropatías desmielinizantes crónicas, como:
    - Neuropatía desmielinizante adquirida distal y simétrica (DADS)
    - Neuropatía multifocal motora (NMM) con bloqueo de la conducción
    - PDIC sensitiva pura
    - Neoplasias malignas hematopoyéticas distintas de la GMSI de tipo IgG o IgA.
    2. Situaciones en las que la patogenia de la neuropatía es diferente a la de la PDIC, como la enfermedad de Lyme, el síndrome de POEMS, el mieloma osteoesclerótico o la enfermedad de Castleman
    3. Tratamiento con:
    - Plasmaféresis en los dos meses previos a la aleatorización.
    - Inmunodepresores y antineoplásicos:
    - azatioprina, ciclofosfamida, ciclosporina, micofenolato, etanercept o metotrexato en los seis meses anteriores a la aleatorización
    - rituximab en los dos años anteriores a la aleatorización
    - otros inmunodepresores (como mitoxantrona, alemtuzumab, cladribina) en cualquier momento
    - Trasplante de células madre hematopoyéticas en cualquier momento.
    4. Recidiva de la PDIC o empeoramiento importante de los síntomas en los dos meses anteriores a la aleatorización.
    E.5 End points
    E.5.1Primary end point(s)
    Delay of disease progression, measured by time to first confirmed worsening on the adjusted INCAT disability scale by 1 point or more from the value at baseline, in patients who were being treated with IVIG and/or corticosteroids prior to study start.
    Retraso de la progresión de la enfermedad, determinado mediante el tiempo transcurrido hasta el primer episodio de empeoramiento confirmado en la Escala de discapacidad INCAT ajustada en 1 punto o más desde el valor en la visita basal, en pacientes que recibieron tratamiento con IVIG o corticosteroides antes del inicio del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    time to event
    Tiempo hasta el episodio
    E.5.2Secondary end point(s)
    1) The change in grip strength from baseline in CIDP patients on fingolimod as compared with those on placebo. Grip strength measurements will be done using a vigorimeter
    2) The change from baseline for Rasch-Built Linearly Weighted Overall Disability Scale (R-ODS). This questionnaire was constructed using the patients perception of their ability to perform daily and social activities
    3) Safety and tolerability of fingolimod compared with placebo in patients with CIDP. Measured by AE/SAE, hematology and biochemistry lab tests, vital signs, ECG, and pulmonary function test.
    1) La variación con respecto al valor basal de la fuerza de prensión en pacientes con PDIC que reciben fingolimod en comparación con los pacientes que reciben placebo. Las medidas de la fuerza de prensión se harán utilizando un vigorómetro.
    2) La variación con respecto al valor basal según la Escala de discapacidad general ponderada linealmente elaborada y según el modelo de Rasch (R-ODS, Rasch-Built Linearly Weighted Overall Disability Scale). Este cuestionario se creó empleando la percepción del paciente sobre su capacidad para realizar las actividades sociales y diarias.
    3) La seguridad y la tolerabilidad del fingolimod en comparación con placebo en pacientes con PDIC, determinada mediante los AA y AAG, los análisis clínicos de hematología y bioquímica, las constantes vitales, el ECG y las pruebas funcionales respiratorias.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) Month 6/ End of treatment
    2) Month 6/ End of treatment
    3) End of study
    1) Mes 6/ Final del tratamiento
    2) Mes 6/ Final del tratamiento
    3) Final 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 Yes
    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 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) Yes
    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.8.2.4Number of treatment arms in the trial2
    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 EEA40
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Greece
    Israel
    Italy
    Japan
    Netherlands
    Norway
    Poland
    Spain
    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
    LVLS
    UVUP
    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 months0
    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 months0
    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: 78
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 78
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 83
    F.4.2.2In the whole clinical trial 156
    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)
    For safety reasons, patients will have a follow-up visit approximately 3 months after study drug discontinuation, regardless of when in the trial they discontinued from study drug.
    Patients who complete the study will have an option to enter in an extension study.
    Por motivos de seguridad, los pacientes tendrán una visita de seguridad de aproximadamente 3 meses después de la interrupción del fármaco del estudio, con independencia de en qué momento del ensayo interrupan el fármaco del estudio.
    Los pacientes que completen el estudio tendrán una opción de entrar 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 Decision2012-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-09-01
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