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    Summary
    EudraCT Number:2009-016266-90
    Sponsor's Protocol Code Number:EFC11072
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2009-12-16
    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 number2009-016266-90
    A.3Full title of the trial
    Estudio aleatorizado, doble-ciego, controlado con placebo, multicéntrico, de dos partes, de búsqueda de dosis y confirmatorio, con un diseño operacionalmente adaptativo que evalúa la eficacia y seguridad de SAR153191 junto con metotrexato (MTX), en pacientes con artritis reumatoide activa con respuesta inadecuadada a la terapia con metotrexato
    __________________________________________________

    A randomized, double-blind, placebo-controlled, multicenter, two-part, dose ranging and confirmatory study with an operationally seamless design, evaluating efficacy and safety of SAR153191 on top of methotrexate (MTX) in patients with active rheumatoid arthritis who are inadequate responders to MTX therapy
    A.3.2Name or abbreviated title of the trial where available
    MOBILITY
    A.4.1Sponsor's protocol code numberEFC11072
    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 SponsorSanofi-aventis Recherche & Développement
    B.1.3.4CountryFrance
    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.3.2Product code SAR153191
    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 codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 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.3.2Product code SAR153191
    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 codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 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.3.2Product code SAR153191
    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 codeSAR153191
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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
    Artritis Reumatoide
    _____________________________________

    Rheumatoid Arthritis
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 12.0
    E.1.2Level LLT
    E.1.2Classification code 10039073
    E.1.2Term Rheumatoid arthritis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Parte A: Demostrar que SAR153191 junto con MTX es eficaz para reducir los signos y síntomas de artritis reumatoide a las 12 semanas
    Parte B:
    Demostrar que SAR153191 junto con MTX es eficaz para reducir los signos y síntomas de AR a las 24 semanas
    E.2.2Secondary objectives of the trial
    Parte B:
    Demostrar que SAR153191 junto con MTX es eficaz para:
    - inhibir la progresión de daño estructural a las 52 semanas
    - mejorar la función física a las 52 semanas
    - inducir una respuesta clínica importante a las 52 semanas
    Evaluar la seguridad de SAR153191 junto con MTX
    Documentar el perfil farmacocinético de SAR153191 junto con MTX, en pacientes con artritis reumatoide activa con respuesta inadecuada a la terapia con MTX
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Extracción de muestras de ADN, ARN y otros biomarcadores para futuras utilizaciones con el propósito de descubrir biomarcadores predictivos. Versión 1, 19 de Octubre de 2009.
    E.3Principal inclusion criteria
    I 01. Diagnóstico de Artritis Reumatoide (AR) tal y como definen los criterios revisados del American College of Rheumatology (ACR) del 1987 con una duración de la enfermedad no inferior a 3 meses y clase ACR I-III (ver Apéndice A).
    I 02. Los pacientes deben estar en una dosis estable de MTX (10 a 25 mg/semana) durante un mínimo de 6 semanas antes de la Visita de Selección y con la intención de continuar así durante todo el estudio.
    I 03. Los pacientes deben haber sido tratados con, y haber tolerado, un mínimo de 12 semanas de tratamiento con metotrexate (MTX) antes de la visita de inclusión.
    I 04. Pacientes con enfermedad activa de moderada a severa definida como:
    - Al menos 8 de 68 articulaciones evaluadas como dolorosas o sensibles al moverlas en las visitas de selección y basal, y,
    - Al menos 6 de 66 articulaciones evaluadas como inflamadas en las visitas de selección y basal, y,
    - Hs Proteína C Reactiva > 10mg/L en la visita de selección
    I 05. Parte B solo:
    - Al menos una erosión ósea documentada localmente (en una radiografía) antes de la primera dosis de la medicación del estudio
    - O, anti PCC o anticuerpo positivo según las analíticas de selección
    - O, factor reumatoide positivo según las analíticas de selección.
    I 06. Que haya firmado un consentimiento informado por escrito antes de realizar cualquier procedimiento relacionado con el estudio.
    E.4Principal exclusion criteria
    E 01.Hombres o mujeres <18 años de edad o >75 años.E 02.Peso <50kg para hombres o <45kg para mujeres o >110 kg. E 03.Enfermedad autoinmune diferente de AR o afectación sistémica significativaE 04.Antecedentes de o enfermedad inflamatoria de las articulaciones aguda actual aparte de AR, o AR diagnosticado antes de los 16 años de edad. E 05.Tratamiento con prednisona oral o equivalente > 10mg diarios durante las 4 semanas previas a la Visita de Inclusión o Uso de glucocorticosteroides parenterales o intra-articulares en las 4 semanas previas a la Visita de Selección. E 06.Iniciar tratamiento o cambiar la dosis del tratamiento actual con AINEs/inhibidores COX2 o corticosteroides orales durante las 4 semanas previas a la visita basal. E 07.Tratamiento actual con FARMEs/agentes inmunosupresores aparte de MTX: ciclosporina, micofenolato, tacrolimus, oro, penicilamina, sulfasalazina o hidroxicloroquinona durante las 4 semanas previas a la Visita de Selección o Azatioprina, ciclofosfamida durante las 12 semanas previas a la Visita de Selección o Leflunomida durante las 12 semanas previas a la Visita de Selección (o 4 semanas después de los 11 días de lavado estándar con colestiramina). E 08. Antecedentes de no responder a tratamiento previo con antagonistas de TNF o un tratamiento biológico. E 09.Tratamiento previo con un antagonista de TNF o cualquier otro agente biológico durante los 3 meses previos a la inclusión. E 10.Participación en algún estudio de investigación clínica que evalúe otro fármaco o tratamiento en investigación en un plazo de 60 días o al menos 5 vidas medias.E 11.Antecedentes de cáncer aparte de carcinoma in-situ de cerviz, o carcinoma de piel escamoso o de células basales no metastático, tratado adecuadamente, durante los cinco años previos a la Visita de Selección. Antecedentes de enfermedad linfoproliferativa o posible enfermedad linfoproliferativa actual. E 12.Antecedentes de abuso de alcohol o drogas durante los 5 años previos a la Visita de Selección. E 13.Tener antecedentes o presencia de otra enfermedad concomitante significativa a criterio del Investigador. E 14.Condiciones/situaciones especiales. E 15. Pacientes que no quieran tomar ácido fólico con la dosis de MTX, para minimizar la toxicidad. E 16. Mujeres embarazadas o en periodo de lactancia. E 17. Exposición previa a SAR153191. E 18. Para mujeres en edad fértil, que no quieran utilizar métodos anticonceptivos adecuados o que no acepten no quedarse embarazadas durante todo el curso del estudio. E 19. Cualquier sujeto que haya sufrido cirugía durante las 4 semanas previas a la Visita de Selección o con cirugía de elección programada. E 20.Pacientes con una tuberculosis (TB) latente o activa definida como: Cualquier signo o síntomas que sugiera TB activa según la historia médica o la exploración clínica, Sujetos positivos a QuantiFERON, prueba de TB o prueba de tuberculina (prueba de DPP cutánea superior o igual a 10mm) en la selección. (ver Sección 10.2), Radiografía de tórax durante los 3 meses previos a la visita de inclusión consistente con infección por tuberculosis previa incluyendo, pero no limitado a, cicatrices apicales, fibrosis apical, o granuloma calcificado múltiple. Esto no incluye granuloma no-caseificado, Sujetos con estrecho contacto con una persona con tuberculosis activa.Tener en cuenta que los pacientes AR tienen más probabilidades de presentar falsos negativos a pruebas cutáneas debido a la inmunosupresión, por lo que solo un análisis cutáneo negativo no será suficiente para excluir la tuberculosis. E 21.Pacientes con antecedentes de Listeria o tuberculosis solucionada (a menos que se documente tratamiento adecuado) E 22.Fiebre superior o igual a 38°C) o infección crónica persistente o recurrente activa que precise tratamiento con antibióticos, antivirales, o antifúngicos durante las 4 semanas previas a la Visita de Selección, o antecedentes de infecciones recurrentes frecuentes inaceptables a criterio del investigador. E 23. Úlceras cutáneas infectadas no curadas. E 24. Que hayan recibido administración de alguna vacuna viva (atenuada) durante los 3 meses previos a la Visita de inclusión (por ejemplo vacuna varicela-zoster, polio oral, rabia). E 25. Que hayan recibido vacuna para BCG durante los 12 meses previos a la selección.E 26. Antecedentes conocidos de anticuerpos del Virus de la Inmunodeficiencia Humana (VIH); y/o antígenos de superficie de la hepatitis B (HBsAg) positivos, y/o anticuerpos de la Hepatitis C (VHC) positivos en la Visita de Selección.E 27,28,29 y 30. Antecedentes varios E 31.Diabetes no controlada, definida como HbA1c superior o igual a 9,0% en la Visita de Selección.E 32. Antecedentes de enfermedad desmielinizante. E 33.Pacientes sometidos a diálisis. E 34.Presencia de anomalías analíticas (para el laboratorio central que realiza las pruebas) en la V.Selección
    E 35. Para hombres que no quieran utilizar dos métodos anticonceptivos, un condón y un espermicida
    E.5 End points
    E.5.1Primary end point(s)
    Parte A:
    Porcentaje de pacientes que alcanzaron ACR20 en la semana 12
    Parte B:
    Porcentaje de pacientes que alcanzaron ACR20 en la semana 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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 EEA50
    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
    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 months3
    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 months3
    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) Yes
    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 state78
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 544
    F.4.2.2In the whole clinical trial 1740
    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 Decision2011-05-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-02-04
    P. End of Trial
    P.End of Trial StatusOngoing
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