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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:2006-001081-16
    Sponsor's Protocol Code Number:P04578
    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:2007-12-14
    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 number2006-001081-16
    A.3Full title of the trial
    Infliximab en pacientes con polimialgia reumática refractaria a corticoides. Ensayo doble ciego controlado con placebo. (Infliximab in patients with rheumatic polymyalgia refractory to corticosteroids. Double blind placebo controlled trial).
    A.4.1Sponsor's protocol code numberP04578
    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 SponsorVictor Martínez Taboada
    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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderCentocor B.V.
    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 Powder for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous drip use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNInfliximab
    D.3.9.3Other descriptive namecA2
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 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 placeboPowder for solution for infusion
    D.8.4Route of administration of the placeboIntravenous drip use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Polimialgia reumática (Rheumatic polymyalgia).
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10036099
    E.1.2Term Polymyalgia rheumatica
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Comparar la eficacia del tratamiento con infliximab en pacientes con polimialgia reumática refractaria al tratamiento corticoide en un período de 24 semanas, a través de la evaluación del porcentaje (%) de pacientes en remisión completa sin corticoides (respondedores) en la semana 24.
    E.2.2Secondary objectives of the trial
    Se analizarán las siguientes variables:
    Evaluar el porcentaje de pacientes en remisión completa sin corticoides (respondedores) en la semana 48.
    Tiempo hasta la respuesta.
    Nº de recidivas/recurrencias.
    Duración de la respuesta.
    Dosis acumulada y efectos secundarios de los corticoides a las 24 y 48 semanas.
    Nº de pacientes que requieren re-tratamiento con infliximab.
    Evaluar la seguridad de las diferentes infusiones de infliximab.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pacientes con polimialgia reumática refractaria al tratamiento con corticoides.
    Cumplir criterios de Chuang modificados:
    Edad mayor o igual a 50 años.
    Dolor y rigidez bilateral de grado moderado o grave, con una duración igual o superior a un mes y que afecten a dos de las siguientes áreas: cuello o tronco, hombros o regiones proximales de los brazos y caderas o regiones proximales de los muslos.
    VSG mayor o igual a 40 mm/H y/o PCR mayor o igual a 2.
    Respuesta clínica completa a dosis bajas de corticoides.
    Hombres y mujeres en edad fértil deben utilizar métodos anticonceptivos adecuados durante el estudio y en los 4 meses posteriores a la última infusión.
    Valores analíticos de hemoglobina, leucocitos, neutrófilos, plaquetas, transaminasas séricas, creatinina sérica, ausencia de anticuerpos anticitrulina y factor reumatoide dentro de los parámetros establecidos en el protocolo.
    Paciente capaz de cumplir el calendario y los procedimientos del estudio.
    Paciente capaz de otorgar su consentimiento informado.
    E.4Principal exclusion criteria
    Pacientes con ACG demostrada por biopsia o con síntomas craneales o con signos indicativos de ACG pero sin arteritis demostrada por biopsia.
    Pacientes con características clínicas indicativas de artritis reumatoide u otros trastornos del tejido conjuntivo.
    Pacientes que presenten sintomatología de artritis periférica.
    Presencia de factor reumatoide > 100 en suero y anticuerpos anticitrulina positivos.
    Presencia de una infección activa, sistémica o localizada.
    Neoplasia o antecedentes de proceso maligno en los 5 años previos.
    Pacientes con esclerosis múltiple u otro trastorno desmielinizante.
    Pacientes vacunados con virus atenuados.
    Pacientes con citopenias: leucopenia, trombocitopenia y/o anemia.
    Pacientes con insuficiencia cardiaca congestiva moderada o grave.
    Cualquier otro proceso que contraindique el tratamiento con infliximab.
    Administración previa de infliximab o etanercept.
    Tratamiento con cualquier fármaco experimental en los 3 meses previos a la inclusión.
    Antecedentes conocidos de alergia a proteínas de roedores o tratamiento con cualquier anticuerpo monoclonal quimérico o murino.
    Signos y síntomas actuales de enfermedad grave, progresiva y no controlada.
    Abuso de drogas o alcohol.
    E.5 End points
    E.5.1Primary end point(s)
    La variable principal es el porcentaje de respondedores a las 24 semanas definidos como evaluación clínica asintomática y remisión analítica.
    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 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) Yes
    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 concerned27
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    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 state50
    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 Decision2007-02-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-01-23
    P. End of Trial
    P.End of Trial StatusOngoing
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