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    The EU Clinical Trials Register currently displays   44156   clinical trials with a EudraCT protocol, of which   7326   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:2009-016587-36
    Sponsor's Protocol Code Number:P06451
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2010-01-27
    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 number2009-016587-36
    A.3Full title of the trial
    Artritis de cadera asociada a la EA. Eficacia y Seguridad del tratamiento precoz con Infliximab (Remicade®)
    A.4.1Sponsor's protocol code numberP06451
    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 SponsorSchering Plough, 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 Yes
    D.2.1.1.1Trade name REMICADE 100 mg polvo para concentrado para solución para perfusión
    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 concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.3Other descriptive nameINFLIXIMAB
    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 Yes
    D.3.11.13.1Other medicinal product typeanticuerpo monoclonal
    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 12.1
    E.1.2Level LLT
    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
    Evaluar la mejoría clínica de la afectación de cadera (en cuanto al dolor, capacidad funcional y rigidez, evaluados por escala WOMAC) en pacientes con EA.
    E.2.2Secondary objectives of the trial
    Evaluar la mejoría de la afectación de cadera mediante técnicas de imagen, tanto convencionales (radiografía) como por RMN.
    Evaluar el valor de la RMN como herramienta de diagnóstico y seguimiento de respuesta al tratamiento, relacionando la evaluación clínica de afectación de cadera con los hallazgos en la exploración por imagen.
    Evaluar la respuesta clínica de la EA según los criterios ASAS20
    Evaluar la actividad de la EA según los nuevos criterios ASDAS
    Evaluar la repercusión sobre la función física, mediante el cuestionario BASFI
    Evaluar la influencia sobre el daño estructural y actividad de la enfermedad de los biomarcadores de daño estructural (MMP3)
    Evaluar la calidad de vida de los pacientes (escalas HAQ y SF-36)
    Evaluar la seguridad del tratamiento con Infliximab, en pacientes con EA y afectación de cadera.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Edad mayor de 18 años
    Diagnostico de espondilitis anquilosante (EA)
    Coxalgia aguda confirmada por RMN (sinovitis, derrame articular, osteitis…)
    Tiempo mínimo de evolución de coxalgia: 3 meses
    Que cumpla las siguientes tres características (debe cumplir las 3):
    -Presencia de dolor referido a cadera (nocturno de naturaleza inflamatoria)
    -Limitación de la movilidad
    - Escala Analógica Visual de Evaluación Global del Paciente (0-10cm) &#8805; 4 cm.
    Paciente refractario a AINES: respuesta inadecuada a tratamiento convencional con AINE según consenso de la SER.
    Paciente apto para ser tratado con Infliximab (Remicade®) según la dosis y recomendaciones descritas en ficha técnica (Anexo 3).
    El paciente debe otorgar Consentimiento Informado por escrito para participar en el estudio.
    E.4Principal exclusion criteria
    Patología de cadera degenerativa asociada a otras causas diferentes a la inflamación confirmada por RM (trocanteritis, coxartrosis secundaria, necrosis avascular o patología de causas blandas).
    Pacientes que ya estén participando o vayan a participar en un ensayo clínico durante el estudio.
    Mujeres embarazadas o lactantes en el momento de la inclusión en el estudio
    Mujeres cuyo periodo de lactancia o embarazo esté previsto antes de los 6 meses después de la última dosis de Infliximab.
    Infecciones graves como sepsis, abscesos.
    Antecedentes de infecciones oportunistas como herpes zoster en los dos meses previos. Evidencia de CMV activo, Pneumocystis carinii microbacteria atípica resistente al tratamiento, etc.
    Infección documentada por VIH, complejo relacionado con SIDA o SIDA.
    Signos y síntomas actuales de enfermedad grave, progresiva y no controlada renal, hepática, sanguínea, endocrina, pulmonar, cardiaca, neurológica o cerebral.
    Antecedentes de trastorno linfoproliferativo, incluido el linfoma, o presencia de signos indicativos de posible proceso linfoproliferativo: linfadenopatías de tamaño o localización inusual o esplenomegalia.
    Neoplasia conocida en el momento actual o antecedentes de cáncer. Se excluye el carcinoma basocelular o el carcinoma de cerviz ‘in situ’ diagnosticados más de un año antes de la inclusión del paciente en el estudio.
    Paciente con TBC activa y pacientes con TBC latente sin tratamiento profiláctico.
    Pacientes con insuficiencia cardiaca moderada o grave (grado III/IV según la clasificación NYHA).
    Pacientes con signos y síntomas de enfermedad desmielinizante.
    Pacientes con historia de hipersensibilidad a Infliximab, a otras proteínas murinas o a alguno de los excipientes.
    E.5 End points
    E.5.1Primary end point(s)
    Porcentaje de pacientes con mejoría clínica según el cuestionario WOMAC (18).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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
    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 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 2010-01-27. 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
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 70
    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 Decision2010-03-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-03-09
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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