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    Summary
    EudraCT Number:2013-001656-35
    Sponsor's Protocol Code Number:109MS408
    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:2014-04-01
    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 number2013-001656-35
    A.3Full title of the trial
    A Multicenter, Open-Label Study Evaluating the Effectiveness of Oral Tecfidera? (Dimethyl Fumarate) on MS Disease Activity and Patient-Reported Outcomes in Subjects with Relapsing-Remitting Multiple Sclerosis in the Real World Setting (PROTEC)
    Estudio abierto multicéntrico para evaluar la eficacia de Tecfidera? oral (dimetilfumarato) en la actividad de la EM y en los resultados notificados por el paciente en sujetos con esclerosis múltiple remitente recidivante en el mundo real (PROTEC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study that evaluates effectiveness of Tecfidera® (Dimethyl Fumarate) in Multiple Sclerosis Patients in a Real World Setting
    Estudio que evalua la eficacia de Tecfidera? (dimetilfumarato) en pacientes con Esclerosis Múltiple en el mundo real.
    A.3.2Name or abbreviated title of the trial where available
    PROTEC
    PROTEC
    A.4.1Sponsor's protocol code number109MS408
    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 Research 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 Research 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 Research Limited
    B.5.2Functional name of contact pointBelén García Alonso
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de la Castellana, 41, 3º
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28034
    B.5.3.4CountrySpain
    B.5.4Telephone number34-91 310 71 66-
    B.5.6E-mailBelen.Garcia@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 Yes
    D.2.1.1.1Trade name Tecfidera
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTecfidera
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number240
    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.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 Tecfidera
    D.2.1.1.2Name of the Marketing Authorisation holderBiogen Idec Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameTecfidera
    D.3.2Product code BG00012
    D.3.4Pharmaceutical form Gastro-resistant 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 INNDIMETHYL FUMARATE
    D.3.9.1CAS number 624-49-7
    D.3.9.2Current sponsor codeBG00012
    D.3.9.3Other descriptive nameDIMETHYL FUMARATE
    D.3.9.4EV Substance CodeSUB13608MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Relapsing-Remitting Multiple Sclerosis
    Esclerosis múltiple remitente recidivante
    E.1.1.1Medical condition in easily understood language
    Multiple Sclerosis
    Esclerosis Múltiple
    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 16.1
    E.1.2Level SOC
    E.1.2Classification code 10029205
    E.1.2Term Nervous system disorders
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level PT
    E.1.2Classification code 10063399
    E.1.2Term Relapsing-remitting multiple sclerosis
    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 estimate the annualized relapse rate (ARR) in subjects with RRMS who are treated with DMF over a 12-month period.
    El objetivo principal del estudio consiste en estimar la tasa de recaídas anual (TRA) en sujetos con EMRR que han sido tratados con DMF durante un periodo de 12 meses.
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study in this population are to assess the impact of DMF over a 12 month period on patient-reported HRQoL outcomes, additional clinical effectiveness outcomes, and health economics-related outcomes, and to characterize patient-reported adherence to DMF.
    Los objetivos secundarios de este estudio en esta población son la evaluación del impacto del DMF durante un periodo de 12 meses según los resultados de CVRS notificados por el paciente, de resultados de eficacia clínica complementarios, de resultados relacionados con la economía de la salud y la caracterización del cumplimiento terapéutico con el DMF notificado por el paciente.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Biomarker Sub-Study. Subjects who consent to participate will provide blood samples that will be used to identify or verify deoxyribonucleic acid (DNA), ribonucleic acid (RNA), and serum markers associated with disease and response to DMF.
    Sub-estudio de Biomarcadores. Los sujetos que acepten participar proporcionarán muestras de sangre que se utilizarán para identificar o verificar ácido desoxirribonucleico (ADN), ácido ribonucleico (ARN) y suero asociados con la enfermedad y la respuesta al DMF.
    E.3Principal inclusion criteria
    Have the ability to understand the purpose and risks of the study and provide signed and dated informed consent and any authorizations required by local law in accordance with national and local subject privacy regulations.

    Have a diagnosis of RRMS and satisfy the approved therapeutic indication for DMF (per the local DMF product information).

    Must be naïve to DMF, Fumaderm®, and other compounded fumarates, and to MS therapies that are primarily prescribed second-line (e.g., natalizumab, fingolimod) and to alemtuzumab.

    Are >18 years old

    Have a recent (i.e., within the previous 6 months) complete blood count (CBC) that does not preclude the subject?s participation in the study, in the judgment of the Investigator.
    Tener la capacidad de comprender el objetivo y los riesgos del estudio y de dar el consentimiento informado firmado y fechado y todas las autorizaciones exigidas por las leyes locales, de acuerdo con la normativa nacional y local sobre la privacidad de los sujetos.

    Tener diagnosticada EMRR y cumplir los requisitos de la indicación terapéutica aprobada para el DMF (según la información del producto DMF local).

    Los sujetos no deben haber sido tratados anteriormente con DMF, Fumaderm®, otros fumaratos compuestos o tratamientos utilizados principalmente como segunda línea (p. ej., natalizumab, fingolimod) ni con alemtuzumab.

    Ser mayores de edad.

    Presentar un hemograma completo (HC) reciente (es decir, dentro de los 6 meses anteriores) que no impida la participación del sujeto en el estudio, según el criterio del investigador.
    E.4Principal exclusion criteria
    Are unwilling or unable to comply with study requirements, or are deemed unsuitable for study participation as determined by the Investigator.

    Have major comorbid conditions that preclude participation in the study, as determined by the Investigator.

    Are pregnant, unless DMF is clearly needed and the potential benefit of DMF to the subjects justifies the potential risk to the fetus, in the judgment of the Investigator (in all countries except Austria). In Austria, pregnant subjects are excluded from participation in the study.

    Are women of childbearing potential and are not using appropriate contraception (per the local DMF product information) as determined by the Investigator.

    Women who are breastfeeding may be excluded (per the local DMF product information) at the discretion of the Investigator.

    Have previously received or are receiving treatment with MS therapies primarily used second-line (e.g., natalizumab, fingolimod) or alemtuzumab, or are currently receiving and planning to continue on other disease-modifying therapies for RRMS, including but not limited to interferon ?, glatiramer acetate, teriflunomide, or laquinimod.

    Are hypersensitive to the active ingredient in the DMF drug product (i.e., DMF) or to any of the excipients listed in the local DMF product information.

    Current enrollment in any clinical trial or Biogen Idec-sponsored study except for the DMF Pregnancy Exposure Registry or other studies that, according to the study Medical Director, do not conflict with this study (e.g., health economics studies or local registries).
    No están dispuestos o no pueden cumplir con los requisitos del estudio, o bien se consideran inadecuados para participar en el estudio, según lo determine el investigador.

    Presentan afecciones comórbidas importantes que les impiden participar en el estudio, según lo determine el investigador.

    Están embarazadas, a menos que el DMF sea claramente necesario y el beneficio potencial del DMF para las sujetos justifique el riesgo potencial para el feto, a juicio del investigador (en todos los países excepto Austria). En Austria, las mujeres embarazadas quedan excluidas de la participación en el estudio.

    Son mujeres fértiles y no están utilizando un método anticonceptivo adecuado (según la información del producto DMF local), según lo determine el investigador.

    Las mujeres en periodo de lactancia podrán excluirse (según la información del producto DMF local) a criterio del investigador.

    Han recibido anteriormente o están recibiendo un tratamiento de la EM usado principalmente como segunda línea (p. ej. natalizumab, fingolimod) o alemtuzumab, o actualmente están recibiendo o planean continuar otros tratamientos de la EMRR modificadores de la enfermedad, incluidos, entre otros, interferón ?, acetato de glatirámero, teriflunomida o laquinimod.

    Son hipersensibles al principio activo del producto farmacológico DMF (es decir, DMF) o a alguno de los excipientes enumerados en la información del producto DMF local (véase la sección 12.1).

    Están inscritos actualmente en otro ensayo clínico o estudio patrocinado por Biogen Idec, excepto para el registro de exposición al DMF durante el embarazo u otros estudios que según el director médico del estudio no entren en conflicto con este estudio (p. ej., estudios de economía de la salud o registros locales).
    E.5 End points
    E.5.1Primary end point(s)
    Annualized Relapse Rate (ARR)
    Tasa de recaídas anual (TRA)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months
    12 meses
    E.5.2Secondary end point(s)
    Change from baseline to Month 12 in:
    - Multiple Sclerosis Impact Scale (MSIS 29) score
    - Modified Fatigue Impact Scale-5 Item (MFIS-5) score
    - Treatment Satisfaction Questionnaire for Medication (TSQM) score
    - EQ-5D 5 level version (EQ-5D-5L) index and EQ Visual Analog Scale (EQ VAS) score
    - Patient-Reported Indices for Multiple Sclerosis-Activity Limitations (PRIMUS-Activity Limitations) score
    - Work Productivity and Activity Impairment-Multiple Sclerosis version (WPAI-MS) score
    - Beck Depression Inventory?Fast Screen (BDI-Fast Screen) score

    Proportion of subjects with confirmed (24-week) Expanded Disability Status Scale (EDSS) progression at Month 12

    The ARR at Baseline (i.e., over the 12 months prior to baseline) and at Month 6

    The proportion of subjects relapsed at Month 12

    Number and proportion of subjects who are hospitalized/have emergency room visits due to MS relapses or have relapses requiring intravenous (IV) steroid treatment during the study, or who make visits to neurologists/other specialists due to MS

    Proportion of subjects who report taking the prescribed DMF dose, overall percent adherence, and reasons for not taking full dose
    Cambio desde el inicio hasta el mes 12 en:
    -La puntuación de la escala del impacto de la esclerosis múltiple (MSIS-29).
    -La puntuación de la escala modificada del impacto de la fatiga de 5 ítems (MFIS-5).
    -La puntuación del cuestionario de satisfacción con el tratamiento para medicamentos (TSQM).
    -El índice del cuestionario de cinco dimensiones con cinco niveles de EuroQuol (EQ-5D-5L) y la puntuación de la escala visual analógica de EuroQuol (EQVAS).
    -La puntuación de los índices notificados por el paciente para la esclerosis múltiple-limitación de actividades (PRIMUS-limitación de actividades).
    -La puntuación del cuestionario de impedimento de la actividad y productividad laboral, versión para la esclerosis múltiple (WPAI-MS).
    -La puntuación del inventario de depresión de Beck-cribado rápido (BDI-FS).

    La proporción de sujetos con progresión confirmada (24 semanas) en la escala ampliada del estado de discapacidad (EDSS) en el mes 12.

    La TRA inicial (es decir, durante los 12 meses anteriores a la inscripción) y en el mes 6.

    La proporción de sujetos con recaída en el mes 12.

    El número y la proporción de sujetos hospitalizados o con visitas a urgencias debido a recaídas de la EM o con recaídas que han necesitado tratamiento con esteroides por vía intravenosa (IV) durante el estudio, o que han visitado al neurólogo u otros especialistas debido a la EM.

    La proporción de sujetos que notifican la toma de la dosis de DMF recetada, el porcentaje general de cumplimiento terapéutico y los motivos de no tomar la dosis completa.
    E.5.2.1Timepoint(s) of evaluation of this end point
    12 months for secondary endpoints except for:
    The ARR at Baseline (i.e., over the 12 months prior to baseline) and at Month 6
    A los 12 meses para los criterios de valoración secundarios excepto:
    La TRA inicial (es decir, durante los 12 meses anteriores a la inscripción) y en el mes 6.
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA109
    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
    Canada
    France
    Italy
    Austria
    Portugal
    Slovakia
    Czech Republic
    Hungary
    Spain
    Slovenia
    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
    LVLS: The end of study is last subject?s last visit (Month 12 End of Treatment/Early Discontinuation Visit) for final collection of data for the primary outcome.
    UVUP: El final del estudio se corresponde con la última visita del último sujeto (visita de fin del tratamiento del mes 12/interrupción prematura) para la recogida final de datos del criterio de valoración principal.
    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 months9
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months5
    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: 1080
    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 state100
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 970
    F.4.2.2In the whole clinical trial 1080
    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)
    There are no post trial treatment plans. DMF will not be made available to subjects after the end of the study under this protocol.
    No hay planes de tratamiento después del Estudio. De acuerdo con este protocolo, el DMF no se pondrá a disposición de los sujetos tras el final del estudio.
    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 Decision2014-06-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
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