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    The EU Clinical Trials Register currently displays   43862   clinical trials with a EudraCT protocol, of which   7285   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2006-001234-40
    Sponsor's Protocol Code Number:RA3103718
    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:2006-07-03
    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 number2006-001234-40
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo para investigar la seguridad, tolerabilidad y actividad clínica de dosis orales repetidas de 7,5 mg de GW856553 dos veces al día durante 28 días, en sujetos con artritis reumatoide activa en tratamiento antirreumático estable.
    A.3.2Name or abbreviated title of the trial where available
    GM2006/00117/00
    A.4.1Sponsor's protocol code numberRA3103718
    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 SponsorGlaxoSmithKline 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 Information not present in EudraCT
    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 nameGW856553 comprimidos
    D.3.2Product code GW856553
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeGW856553
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number2.5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameGW856553 comprimidos
    D.3.2Product code GW856553
    D.3.4Pharmaceutical form Film-coated tablet
    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.3.9.2Current sponsor codeGW856553
    D.3.10 Strength
    D.3.10.1Concentration unit mg/g milligram(s)/gram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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 placeboFilm-coated tablet
    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
    Artritis reumatoide (AR)
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • Investigar la actividad clínica de GW856553 tras 28 días de administración en sujetos con AR, medida por la puntuación DAS28 (calculada utilizando la VSE) en comparación con placebo.
    E.2.2Secondary objectives of the trial
    •Investigar seguridad y tolerabilidad de GW856553 tras 28 d.
    •Investigar actividad clínica de GW856553 tras 28 d en comparación con placebo, medida por DAS28 (calculada utilizando PCR) y medida por % de sujetos que alcanzan puntuaciones ACR20/50/70.
    •Objetivos adicionales: investigar actividad clínica de GW856553 tras 28 d comparado con placebo por: efectos sobre biomarcadores; cambios en el dolor, fatiga y calidad de vida; efecto sobre articulaciones. Tambien, caracterizar la farmacocinética de población de GW856553 e investigar la potencial correlación entre exposición plasmática a GW856553 y surrogados de enfermedad [ej, PCR y sustancia sérica amiloidea A (A-SAA)] y variables clínicas (ejemplo, ACR20 y DAS28).
    •Objetivos opcionales: Investigar seguridad, tolerabilidad y efecto sobre biomarcadores, eficacia clínica e inflamación sinovial, de la administración de 7,5mg GW856553 BID durante 8 sem., comparado con placebo.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Un sujeto sólo será elegible para participar en este estudio si cumple todos los criterios siguientes:
    1. Hombres o mujeres de ≥18 años de edad.
    Para ser elegibles, las mujeres deben tener una prueba de embarazo (hCG en suero) negativa y ser:
    a) no fértiles (es decir, fisiológicamente incapaces de quedarse embarazadas). Esto incluye a las mujeres postmenopáusicas. Para los objetivos de este estudio, la postmenopausia se define como una amenorrea de más de 2 años con un perfil clínico apropiado, por ejemplo, edad apropiada, historia de síntomas vasomotores. El estado postmenopáusico se confirmará midiendo la concentración sérica de FSH y estradiol en la selección. La esterilidad quirúrgica se definirá como mujeres que han sido sometidas a histerectomía y/o ooforectomía bilateral o ligadura de trompas.
    O
    b) potencialmente fértiles y estar de acuerdo en utilizar uno de los métodos anticonceptivos aprobados en el protocolo y que se detallan en la Sección 7.1.
    2. Peso corporal ≥50kg en los hombres y ≥45kg en las mujeres.
    3. Índice de masa corporal (IMC) dentro del rango de 18,5-35 kg/m2 inclusive.
    4. Sujetos con diagnóstico de AR de acuerdo con los criterios revisados de 1987 del American College of Rheumatology (ACR) (ver Apéndice 6).
    5. Sujetos con una puntuación DAS28 ≥4,2 (DAS28 calculado utilizando la VSE).
    6. Sujetos con pruebas de función hepática (ALT, AST y bilirrubina total) <1,5 x LSN en la selección.
    7. Sujetos con valores de ALP <2 x LSN en la selección.
    8. Sujetos con niveles séricos normales de folato en la selección (se pueden administrar suplementos de folato si es necesario pero deben mantenerse estables durante 4 semanas antes de la aleatorización).
    9. Sujetos capaces de entender y cumplir los requisitos, instrucciones y restricciones del protocolo.
    10. Sujetos que hayan firmado y fechado el consentimiento informado por escrito antes de su inclusión en el estudio.
    E.4Principal exclusion criteria
    Un sujeto no será elegible para participar en el estudio si cumple cualquiera de los siguientes criterios:
    1. Sujetos con una historia anterior de tres meses de consumo regular de alcohol que supera una ingestión semanal media de >21 unidades (o una ingestión diaria media de más de 3 unidades) en los hombres, o una ingestión semanal media de >14 unidades (o una ingestión diaria media mayor de 2 unidades) en las mujeres. 1 unidad equivale a 284ml de cerveza, 25ml de licores o 125ml de vino; o con una prueba de alcohol en el aire espirado positiva en la visita de selección.
    2. Sujetos con historia de hepatopatías.
    3. Sujetos con un resultado positivo para el antígeno de superficie de hepatitis B o para anticuerpos de hepatitis C en los 3 meses anteriores al comienzo del estudio.
    4. Sujetos con historia de pruebas de función hepática elevadas en más de una ocasión (ALT, AST y bilirrubina total >2 x LSN o ALP >3 x LSN) en los 7 últimos meses.
    5. Sujetos que actualmente estén recibiendo una terapia biológica antirreumática.
    6. Sujetos que hayan fracasado a más de una terapia biológica anti-TNF debido a falta de eficacia.
    7. Sujetos que hayan recibido una terapia biológica antirreumática en los 6 meses (para las terapias i.v. con semividas largas, ejemplo, infliximab) o 3 meses (para las terapias subcutáneas o i.v. con semividas cortas, ejemplo, adalimumab o etanercept) anteriores a la aleatorización.
    8. Sujetos que hayan recibido rituximab.
    9. Sujetos que estén tomando prednisolona oral a dosis >10mg/día, metrotexato >25mg/semana o sulfasalazina >5g/día.
    10. Sujetos en los que el régimen de FAMEs haya cambiado durante las 4 semanas anteriores a la aleatorización.
    11. Sujetos en los que el régimen actual de FAMEs haya cambiado significativamente (es decir, con probabilidad de alterar la actividad de la enfermedad durante el periodo de estudio) en los 3 meses anteriores al tratamiento; ejemplo, adición de un FAME, cambios en la dosis de metotrexato de más de 2,5mg.
    12. Sujetos que hayan recibido leflunomida durante menos de 6 meses antes de la aleatorización.
    13. Sujetos que hayan fracasado a más de 3 FAMEs.
    14. Sujetos en los que el régimen de AINEs, inhibidores de la COX-2 o glucocorticoides haya cambiado en algún momento durante las 4 semanas anteriores a la aleatorización.
    15. Sujetos cuyo régimen de estatinas se haya modificado significativamente durante los 3 meses anteriores a la aleatorización.
    16. Sujetos con trastornos cardíacos, pulmonares, metabólicos, renales, hepáticos o gastrointestinales significativos que, a juicio del investigador y/o del monitor médico de GSK, pongan al sujeto en un riesgo inaceptable si participa en este estudio.
    17. Sujetos con una infección aguda o con historia de infecciones repetidas o crónicas.
    18. Sujetos con historia de tuberculosis activa.
    19. Sujetos con historia de cáncer, excepto el carcinoma de células basales curado quirúrgicamente o, en las mujeres, el carcinoma cervical curado (>2 años antes).
    20. Sujetos con historia de infección por VIH u otras enfermedades inmunosupresoras.
    21. Sujetos que hayan participado en un ensayo clínico en los 3 meses anteriores al comienzo del estudio para la terapia no biológica, o en los 6 meses para la terapia biológica.
    22. Sujetos con un valor de Hb <9g/dl y un recuento de plaquetas <150.000/mm3.
    23. Sujetos con un aclaramiento calculado de creatinina inferior a 50ml/min.
    24. Sujetos con psoriasis o diabetes no controladas.
    25. Sujetos que han recibido una inyección intraarticular de un glucocorticoide en las 4 semanas anteriores.
    26. Mujeres en estado de gestación o de lactancia.
    E.5 End points
    E.5.1Primary end point(s)
    • Puntuación de la Actividad de la Enfermedad basada en el recuento de 28 articulaciones [recuento de articulaciones inflamadas, recuento de articulaciones dolorosas, evaluación global por el sujeto del estado de la artritis, VSE].
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    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.8.5The trial involves multiple Member States No
    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 Information not present in EudraCT
    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
    El final del ensayo será la última visita del último paciente.
    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 months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months8
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-03. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 10
    F.4.2.2In the whole clinical trial 48
    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)
    As per the expected normal treatment of the condition.
    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 Decision2006-10-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-08-07
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-01-21
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