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    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   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:2005-003558-83
    Sponsor's Protocol Code Number:20050168
    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:2006-02-16
    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 number2005-003558-83
    A.3Full title of the trial
    Estudio aleatorizado, doble ciego, controlado con placebo, y de dosis múltiple, para evaluar la eficacia, seguridad y farmacocinética de AMG 108 subcutáneo en sujetos con artritis reumatoide. (A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Subcutaneous AMG 108 in Subjects with Rheumatoid Arthritis).
    A.4.1Sponsor's protocol code number20050168
    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 SponsorAmgen Inc.
    B.1.3.4CountryUnited States
    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.3.2Product code AMG 108
    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 codeAMG 108
    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) 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 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 - RA)
    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
    El objetivo principal de este estudio es determinar si AMG 108, a una dosis mensual subcutánea de 250 mg o menor, en combinación con metotrexato (MTX) demuestra una mayor frecuencia de respuesta clínica (ACR20) que la observada con placebo (MTX solo) en sujetos AR en la Semana 16 de tratamiento.
    E.2.2Secondary objectives of the trial
    Determinar si AMG 108, a una dosis mensual de 250 mg SC o menor, en combinación con metotrexato (MTX) demuestra una eficacia del 20% o superior en la respuesta clínica (ACR20) a la observada con MTX solo, en sujetos con AR en la Semana 16 de tratamiento.
    Evaluar el perfil de seguridad a corto plazo de AMG 108 en combinación con MTX en sujetos con AR a dosis mensual de hasta 250 mg subcutáneo (SC).
    Determinar si la respuesta clínica en sujetos tratados con MTX y AMG108 a una o más dosis, comparando la Semana 16 con la basal, es superior a la de MTX solo basándose en:·
    1. La proporción de sujetos que alcanza una respuesta ACR50 y ACR70.
    2. Puntuación DAS28 y cambio en la puntuación DAS28 desde la basal (respuesta EULAR28).
    3. Determinación de ACRn y AUC ACRn.
    Determinar los parámetros farmacocinéticos de AMG108 en sujetos con AR tras administración SC.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Los sujetos deben estar diagnosticados de AR según los criterios de clasificación determinados en la reunión de 1987 del American College of Rheumatology (ACR).
    AR activa definida como ≥6 articulaciones hinchadas y ≥ 6 articulaciones sensibles/doloridas y al menos uno de los siguientes: VSG ≥28 mm/h, PCR > 2,0 mg/dL, o duración de rigidez matutina ≥45 minutos en el momento de la selección.
    Duración de AR de al menos 6 meses.
    Hombres o mujeres ≥18 y ≤70 años.
    Sujetos con enfermedad activa tras un mínimo de 4 semanas de tratamiento con MTX o 2 semanas para sulfasalacina o hidroxicloroquina.
    Tratamiento estable con metotrexato oral o subcutáneo (≥4 semanas antes de la selección) a 10-25 mg semanales.
    Si usan fármacos antiinflamatorios no esteroideos (AINEs) o corticosteroides orales (≤10 mg prednisona o equivalente), el tratamiento debe ser estable durante ≥4 semanas antes de la selección.
    Antes de realizar cualquier procedimiento específico del estudio, debe obtenerse el consentimiento informado por escrito.
    E.4Principal exclusion criteria
    Tratamiento previo con biológicos comercializados o experimentales, incluyendo AMG 108, anakinra (Kineret®), AMG 719, receptor soluble tipo II de IL-1, etanercept, infliximab, adalimumab, onercept, pegsunercept, abatacept, o rituximab o cualquier otro tratamiento biológico utilizado para tratar una enfermedad inflamatoria.
    Enfermedad sistémica clínicamente significativa no controlada aparte de AR como diabetes mellitus, enfermedad cardiovascular o hipertensión.
    Neoplasia en los últimos 5 años (excepto cáncer cervical in situ o escamoso o carcinoma de células basales tratados).
    Presencia de una infección grave, definida como infecciones que precisan hospitalización o recurrentes, agudas o crónicas en las 8 semanas previas a la selección.
    Antecedentes de infección o exposición a M. tuberculosis previa o actual.
    AR de clase IV (Hochberg 1992) según el criterio de respuesta revisado por ACR o enfermedad en estadio final radiográfico.
    Infección articular prostética en los 5 años previos a la selección o infección articular nativa durante el año previo a la selección.
    Síndrome de Felty.
    Enfermedad inflamatoria crónica importante o enfermedad del tejido conectivo aparte de AR, con la excepción de síndrome de Sjögren secundario.
    Resultado positivo conocido al antígeno de superficie para hepatitis B (HbsAg), virus de la hepatitis C (CHV) o VIH.
    Glóbulos blancos < 3.0 x 103 / mL, recuento absoluto de neutrófilos (RAN) < 2.5 x 103 / mL, o plaquetas < 125 x 103 / mL durante la selección.
    Aumento de AST/ALT > 1,5 x límite superior de normalidad.
    Aumento de creatinina sérica > 1,5 x límite superior de normalidad o > 2 mg/dL.
    Anomalía de laboratorio que, en opinión del investigador, evitará que el sujeto finalice el estudio o interferirá con la interpretación de los resultados del estudio.
    Inyecciones de corticosteroides intra-articulares o sistémicas en las 4 semanas previas a la selección.
    Cualquier FME aparte de metotrexato en las 6 semanas previas a la selección.
    Ciclofosfamida en los 6 meses previos a la selección.
    Haber recibido vacunas vivas durante los 3 meses previos a la primera dosis de producto en investigación.
    Cualquier tratamiento en investigación en las 4 semanas previas a la selección.
    Embarazo o lactancia.
    Sujetos sexualmente activos y sus parejas en edad fértil (ni esterilización quirúrgica ni postmenopausia) y que no utilicen anticonceptivos adecuados.
    Sensibilidad conocida a productos obtenidos de células de mamíferos.
    Cualquier alteración física o psiquiátrica que, en opinión del investigador, evitará que el sujeto finalice el estudio o interferirá con la interpretación de los resultados del estudio.
    Cualquier alteración que comprometa la capacidad del sujeto de dar el consentimiento informado por escrito y/o cumplir con los procedimientos del estudio.
    Abuso de sustancias activas (en las 24 semanas previas a la selección).
    Que precisen o tengan una condición que haga prever el uso de analgésicos narcóticos fuertes (excepto hidrocodona, codeina, dextropropoxifeno, propoxifeno o oxicodona) o medicación derivada de la morfina para el alivio analgésico en la selección.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es la respuesta ACR20 en la Semana 16.
    Las variables secundarias son:
    Respuestas ACR50 y ACR70 en la Semana 16.
    Puntuación DAS28 y cambio en la puntuación DAS28 desde la basal (respuesta EULAR28) en la Semana 16.
    ACRn y AUC ACRn en la Semana 16.
    Parámetros de PK de AMG 108 (como Cmax, Tmax, y AUC0-t) tras la 1ª dosis (el Día 1) y después de la 4ª dosis (en la Semana 12) para el sub-grupo con evaluaciones más frecuentes de PK.
    Las variables de seguridad incluyen:
    Acontecimientos adversos derivados del tratamiento y acontecimientos adversos infecciosos.
    Acontecimientos adversos graves (AAGs) y acontecimientos infecciosos graves (AIGs).
    Severidad de las reacciones en el lugar de la inyección.
    Cambios significativos en los valores de laboratorio y constantes vitales.
    Cambios en el estado de anticuerpos anti-AMG 108.
    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 Yes
    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 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) 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 Yes
    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 fin del estudio se define como la fecha de la última visita del último paciente en el estudio.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 Information not present in EudraCT
    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 2006-02-16. 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 Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 475
    F.4.2.2In the whole clinical trial 784
    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)
    Tratamiento habitual
    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 Decision2006-04-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-03-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2008-02-06
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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