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    Summary
    EudraCT Number:2009-017309-12
    Sponsor's Protocol Code Number:GRE-2009-01
    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:2009-12-18
    Trial 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 number2009-017309-12
    A.3Full title of the trial
    Evaluación de la respuesta a etoricoxib en pacientes con Espondilitis Anquilosante (EA) e inadecuada respuesta > o = a 2 AINES
    A.4.1Sponsor's protocol code numberGRE-2009-01
    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 SponsorFUNDACIÓN ESPAÑOLA DE REUMATOLOGÍA (FER)
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 Yes
    D.2.1.1.1Trade name ARCOXIA 90 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK SHARP AND DOHME DE ESPAÑA, S.A.
    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 No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form 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.3.8INN - Proposed INNETORICOXIB
    D.3.9.3Other descriptive nameETORICOXIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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
    Espondilitis Anquilosante
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. Evaluar el porcentaje de pacientes que cumplen con los criterios de respuesta del Grupo
    de Trabajo Internacional de Evaluación de la Espondilitis Anquilosante (ASAS) para terapias biológicas (ASASBIO) tras 4 semanas de tratamiento con etoricoxib 90 mg/día.
    Un paciente se considerará respondedor al criterio ASASBIO si muestra un 50 % de
    cambio (disminución) relativo o un cambio (disminución) absoluto de 2 (escala 0-10) en el
    BASDAI y en opinión del experto.
    E.2.2Secondary objectives of the trial
    1.- Evaluar el porcentaje de pacientes que cumplen con los criterios de respuesta ASAS para
    terapias biológicas (ASASBIO) tras 2 semanas de tratamiento y evaluar si la respuesta positiva es predictiva de la respuesta a las 4 semanas.
    2.- En los pacientes que hayan respondido positivamente al tratamiento a la semana 4 y, que en opinión del investigador deban continuar la terapia, evaluar el mantenimiento de la
    respuesta a la semana 12 y a la semana 24.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Pacientes > ó = a 18 años.
    2. Pacientes con diagnóstico de EA (de acuerdo a los criterios modificados de Nueva York
    1984) (Apéndice II) realizados al menos 6 meses antes del comienzo del estudio.
    3. Pacientes con afectación axial.
    4. Pacientes que han sido tratados con 2 ó más AINEs documentados, con capacidad
    antiinflamatoria probada, durante al menos un total de 3 meses a la dosis máxima
    recomendada o tolerada.
    5. Pacientes que han obtenido una puntuación (rango de 0 a 10) en "Bath Ankylosing
    Spondylitis Disease Activity Index" (BASDAI) > ó = a 4.
    E.4Principal exclusion criteria
    1. El paciente es legalmente incapaz (p. ej., una menor o persona mentalmente incapaz),
    tiene antecedentes de un trastorno psiquiátrico importante o presenta una psicosis activa o
    problemas emocionales importantes en el momento del estudio que, en opinión del
    investigador, son suficientes para interferir en la realización del estudio.
    2. El paciente está participando en un estudio con un compuesto o dispositivo experimental, o lo ha hecho en las 4 semanas anteriores a la firma del consentimiento informado.
    3. El paciente tiene antecedentes recientes (durante los últimos 5 años) de abuso o
    dependencia crónica de opiáceos o tranquilizantes, consume drogas en el momento de firmar el consentimiento informado o tiene antecedentes recientes (durante los últimos 5
    años) de alcoholismo o drogadicción.
    4. El paciente tiene antecedentes de una enfermedad neoplásica o neoplasia maligna
    < ó = a 5 años antes de firmar el consentimiento informado, salvo un cáncer basocelular o
    espinocelular de piel tratado adecuadamente o un cáncer in situ de cuello uterino, siempre
    que, según el criterio del investigador y médico encargado del tratamiento, el seguimiento
    oportuno no haya revelado datos de recidiva entre el momento de tratamiento y el momento
    de selección. Las pacientes con antecedentes de leucemia, linfoma, melanoma maligno o
    enfermedad mieloproliferativa no podrán participar en el estudio independientemente del
    tiempo transcurrido desde el tratamiento y, en tales casos, no habrá excepciones.
    5. La paciente está embarazada o lactando, o espera concebir un hijo durante el estudio.
    6. El paciente tiene antecedentes o datos actuales de cualquier trastorno, tratamiento o
    anomalía de laboratorio que pueden confundir los resultados del estudio o interferir en su
    participación durante todo el estudio, o no es conveniente para él participar.
    7. Es improbable que el paciente cumpla los procedimientos del estudio o acuda a las citas,
    o el paciente tiene previsto mudarse durante el estudio.
    8. Pacientes que estén esperando la evaluación legal del grado de discapacidad o la discapacidad laboral permanente.
    9. Pacientes que tienen dificultades para contestar adecuadamente el cuestionario, debido a problemas de comprensión y/o de lectura.
    10. Cualquier otro motivo que, en opinión del investigador, pueda disuadir la inclusión del
    paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    El objetivo primario es calcular el porcentaje de pacientes que cumplen con los criterios de respuesta para terapias biológicas (ASASBIO) (14) a la semana 4.
    Un paciente se considerará respondedor al criterio ASASBIO si muestra un 50 % de
    cambio (disminución) relativo o un cambio (disminución) absoluto de 2 (escala 0-10) en el
    BASDAI y en opinión del experto.
    El ASASBIO se calculará a la semana 2 y 4, y a la semana 12 y 24 en aquellos pacientes con respuesta positiva en la semana 4 que hayan continuado con el tratamiento.
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    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 Yes
    E.8.1.7.1Other trial design description
    Abierto
    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.8.3 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 concerned15
    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 No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    Estudio multicéntrico, abierto, de 4 semanas de duración. Aquellos pacientes que, bajo el criterio del investigador, alcancen suficiente respuesta clínica a la semana 4 como para mantener el tratamiento con etoricoxib, continuarán con éste para evaluar el mantenimiento de la respuesta a la semana 12 y 24.
    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 months6
    E.8.9.1In the Member State concerned 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 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 2009-12-18. Yes
    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 state70
    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 Decision2010-02-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-02-09
    P. End of Trial
    P.End of Trial StatusCompleted
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