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    The EU Clinical Trials Register currently displays   37504   clinical trials with a EudraCT protocol, of which   6153   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2008-008934-35
    Sponsor's Protocol Code Number:ORDI-01
    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:2009-04-16
    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 number2008-008934-35
    A.3Full title of the trial
    ENSAYO CLÍNICO ALEATORIZADO Y CONTROLADO PARA EVALUAR LA EFICACIA DE LA AZATIOPRINA VS. MICOFENOLATO SÓDICO PARA EL TRATAMIENTO DE LA FASE DE INDUCCIÓN Y MANTENIMIENTO DE LA REMISIÓN DE LOS BROTES EXTRA RENALES DEL LUPUS ERITEMATOSO SISTÉMICO.
    A.4.1Sponsor's protocol code numberORDI-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 SponsorDr Josep Ordi-Ros. Hospital Universitario Vall d'Hebron
    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 RoleComparator
    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 IMUREL 50 mg comprimidos recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderUCB PHARMA, 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 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.3.8INN - Proposed INNAZATIOPRINA
    D.3.9.1CAS number 446-86-6
    D.3.9.3Other descriptive nameAZATHIOPRINE
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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.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 Yes
    D.2.1.1.1Trade name MYFORTIC 360 mg comprimidos gastrorresistentes recubiertos con película
    D.2.1.1.2Name of the Marketing Authorisation holderNOVARTIS FARMACEUTICA, 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 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.3.8INN - Proposed INNMICOFENOLICO ACIDO
    D.3.9.3Other descriptive nameMYCOPHENOLIC ACID
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number360
    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
    Lupus Eritematoso Sistémico
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10025139
    E.1.2Term Lupus erythematosus systemic
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la eficacia del tratamiento con micofenolato sódico en comparación con el tratamiento convencional con azatioprina para las manifestaciones extra-renales del Lupus Eritematoso Sistémico. Se definirá eficacia como la tasa de pacientes con respuesta clínica completa (si/no) en la semana 8 para los brotes leves/moderados y a la semana 12 en los brotes severos.
    Remisión Completa se definirá como un SLEDAI &#8804;4 y/o ausencia de cualquier BILAG A o B
    E.2.2Secondary objectives of the trial
    •Evaluar la disminución del número de brotes de la enfermedad durante la fase de seguimiento.
    •Evaluar la reducción en el requerimiento de la dosis de corticoides orales a lo largo del tratamiento.
    •Evaluar la mejoría en los parámetros inmunológicos como son una reducción en los títulos de anticuerpos anti-DNA y una normalización de los niveles de complemento.
    •Evaluar las secuelas residuales debido a la enfermedad a lo largo del estudio mediante la escala de daño orgánico (SLICC).
    •Evaluar el impacto del tratamiento en la calidad de vida del paciente y la satisfacción subjetiva de los pacientes, mediante la escala del SF-36.
    •Evaluar la tolerabilidad y desarrollo de efectos secundarios por parte de ambos fármacos.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.- Edad &#8805;18 años (18 – 65). Pacientes con menos de 18 años se incluirán con el consentimiento de un tutor
    2.- Cumplir por lo menos 4 de los criterios diagnósticos del ACR (22) para el diagnóstico del LES (anexo 1)
    3.- Cualquier brote extra-renal de la enfermedad con un SLEDAI &#8805;6 y/o con un BILAG A o 2 BILAG B que requiera para su control dosis adecuadas de antipalúdicos y &#8805;10 mg/día de prednisona o que requiera la introducción de un fármaco inmunosupresor debido a la severidad o al órgano implicado o por ser recidivante a pesar de un buen control inicial con la terapia antipalúdica y/o corticoide a dosis &#61603;10 mg/día

    Se incluirán también pacientes que desarrollen manifestaciones hematológicas aisladas y/o pleuropericarditis recidivantes o que no se controlen con el tratamiento mencionado anteriormente aunque el SLEDAI &#8804;6

    Los brotes se clasificarán como moderados y severos con la finalidad de definir el tratamiento a seguir. BROTE MODERADO: Se definirá como un brote con SLEDAI &#8805;6 pero &#8804;12. ROTE SEVERO: Se definirá como un Índice de SLEDAI&#8805;12.
    4.- Medicación estable en los 30 días previos en alguna de las siguientes medicaciones (sola o en combinación)

    1.Corticosteroides a dosis >10 mg/día
    2.Hidroxicloroquina a dosis de 400 mg/d

    5.- En caso de mujeres, éstas no deben quedarse embarazadas y deben utilizar métodos de barrera como contracepción
    E.4Principal exclusion criteria
    1.- Evidencia de un brote renal activo.
    2.-Intolerancia o hipersensibilidad previa a uno de los dos principios
    3.-Presencia de una infección activa.
    4.-Niveles indosificables de TMPT (Tiometil purin transferasa).
    5.-Embarazo
    6.- Tratamiento con MMFs, azatioprina u otro inmunosupresor en los 2 meses previos al estudio.
    7.- Brote de enfermedad severa que precise por criterio del médico responsable de otros tratamientos inmunosupresores de los que existe una mejor evidencia de eficacia
    8.-Patología psiquiátrica o social concomitante que dificulte la colaboración y el seguimiento del paciente.
    9.-Evidencia de una alteración analítica, en los 30 días antes de la inclusión en el estudio
    . ALT o GPT >120 UI/mL
    . Leucocitos <1000x106 no relacionado con el LES

    10. Síntomas directamente relacionados a otras causas diferentes del LES como por ejemplo al síndrome antifosfolípido o evidencia de una enfermedad aguda o crónica no médicamente controlada, diferente del LES (ejemplo: enfermedad cardiopulmonar)
    E.5 End points
    E.5.1Primary end point(s)
    Evaluar la eficacia del tratamiento con micofenolato sódico en comparación con el tratamiento convencional con azatioprina para las manifestaciones extra-renales del Lupus Eritematoso Sistémico. La eficacia al tratamiento se basará en una mejoría en las escalas de actividad de la enfermedad (SLEDAI y BILAG) Se definirá eficacia como la tasa de pacientes con respuesta clínica completa (si/no) en la semana 8 para los brotes leves/moderados y a la semana 12 en los brotes severos. Remisión Completa se definirá como un SLEDAI &#8804;4 y/o ausencia de cualquier BILAG A o B.
    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) 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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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 Yes
    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 years3
    E.8.9.1In the Member State concerned months0
    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) No
    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 state240
    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 Decision2009-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-03-04
    P. End of Trial
    P.End of Trial StatusOngoing
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