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    Summary
    EudraCT Number:2011-000885-36
    Sponsor's Protocol Code Number:APPRECIA
    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:2011-11-29
    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 number2011-000885-36
    A.3Full title of the trial
    Multicentric, randomized double blind clinical trial and paralell groups to compare Adalimub vs Azatioprina efficacy prevention in Crhon disease post-surgical recurrency after 52 weeks of treatment
    Ensayo clínico multicéntrico, aleatorizado, con simple ciego y de grupos paralelos para comparar la eficacia de Adalimumab con la de Azatioprina en la prevención de la recurrencia postquirúrgica en la enfermedad de Crohn después de 52 semanas de tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Adalimub treatment to prevent recurrency post-surgery in Crohn disease.
    Tratamiento con Adalimumab para prevenir la recurrencia post-cirugía en la enfermedad de Crohn
    A.3.2Name or abbreviated title of the trial where available
    APPRECIA
    APPRECIA
    A.4.1Sponsor's protocol code numberAPPRECIA
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorGETECCU
    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 supportAbbott Laboratories
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGETECCU
    B.5.2Functional name of contact pointDr. Fernando Gomollón
    B.5.3 Address:
    B.5.3.1Street AddressGran Vía nº 81 - 5º Dpto. 10
    B.5.3.2Town/ cityBilbao
    B.5.3.3Post code48011
    B.5.3.4CountrySpain
    B.5.4Telephone number+34944278855
    B.5.5Fax number+34944278808
    B.5.6E-mailinfo@congresosxxi.com
    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 Humira
    D.2.1.1.2Name of the Marketing Authorisation holderAbbott Laboratories UK
    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.3.1Product nameHumira
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    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 INNAdalimumab
    D.3.9.1CAS number 331731-18-1
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameAdalimumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number160
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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 typeun anticuerpo monoclonal humano recombinante expresado en células de Ovario de Hámster Chino.
    D.IMP: 2
    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
    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.3.1Product nameImurel
    D.3.4Pharmaceutical form Powder for solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAzatioprina
    D.3.9.1CAS number 6336-41-0
    D.3.9.3Other descriptive nameImurel
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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: 3
    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 Flagyl
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi-aventis Francia
    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.3.1Product nameFlagyl
    D.3.4Pharmaceutical form Oral suspension
    D.3.4.1Specific paediatric formulation No
    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 INNMetronidazol
    D.3.9.1CAS number 99616-64-5
    D.3.9.3Other descriptive nameFlagyl
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number125
    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) No
    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 No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    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 No
    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
    Compare efficay of Adalimub vs Azatioprina to prevent surgical intervention in Chron disease
    comparar la eficacia de Adalimumab con la de Azatioprina para prevenir la intervencion postquirúrgica en la enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn disease surgery recurrency
    recurrencia de la cirugía en la enfermedad de Crohn
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    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
    Evaluar la eficacia de Adalimumab vs. Azatioprina en la prevención de la recurrencia endoscópica (cuantificada con el Indice de Rutgeerts y definida como un índice de 2b, 3 ó 4) en la Enfermedad de Crohn tras 52 semanas de tratamiento.
    E.2.2Secondary objectives of the trial
    -Comparar el porcentaje de pacientes en remisión clínica tras 24 y 52 semanas de tratamiento con Adalimumab o Azatioprina utilizando como variable de medida el Índice de Actividad de la Enfermedad de Crohn (CDAI), considerando como inactividad una puntuación menor o igual 200.
    -Evaluar la eficacia de Adalimumab en la prevención de la recurrencia post-quirúrgica medida por Entero-RM en la semana 52.
    -Evaluar la correlación entre la remisión endoscópica y la Entero-RM.
    -Comparar el porcentaje de pacientes que requieren hospitalización con Adalimumab o Azatioprina en la semana 52.
    -Evaluar los cambios en los marcadores de actividad de la enfermedad, tales como calprotectina fecal, proteína C reactiva y VSG en las semanas 24 y 52.
    -Comparar el porcentaje de pacientes que requieren cirugía con Adalimumab o Azatioprina hasta la semana 52.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Edad mayor o igual a 18 años cumplidos en el momento de la firma del consentimiento informado.
    -Pacientes de ambos sexos.
    -Pacientes con enfermedad de Crohn a los que se les haya realizado una resección ileocecal/ileocolica (L1 o L3).
    -Pacientes con reconstrucción quirúrgica con anastomosis ileocólica.
    -Pacientes con o sin respuesta previa a IMM y anti-TNF.
    -Las mujeres con capacidad fértil no deberán estar amamantando y deberán tener un test de embarazo en orina negativo y deberán comprometerse a utilizar métodos anticonceptivos con un índice de fracasos < 1% (ej., anticonceptivos orales, métodos de doble barrera, dispositivos intrauterinos), salvo que solo tengan una única pareja y que ésta sea estéril.-Pacientes que hayan firmado y fechado el formulario de consentimiento informado antes de realizar cualquier procedimiento de selección específico para el estudio.
    E.4Principal exclusion criteria
    -Resección que requiera ileostomía temporal.
    -Resección de urgencia que no permita completar el protocolo inicial de evaluación.
    -Resección debida a estenosis indolente corta (< 10 cm) inactiva.
    -Resección con enfermedad mucosa macroscópica residual en la anastomosis.
    -Previa intolerancia o reacción adversa moderada o grave a adalimumab o azatioprina.
    -Cualquier contraindicación o renuencia a realizar las colonoscopias o resonancias programadas.
    -Contraindicaciones al tratamiento con Adalimumab, entre las que se incluyen, entre otras, las siguientes: tuberculosis activa, infecciones graves como la sepsis o las infecciones oportunistas, insuficiencia cardíaca moderada o grave (NYHA clases III o IV), tratornos desmielinizantes del sistema nervioso central, antecedentes de neoplasia maligna o de enfermedades autoinmunes.
    -Manifestaciones extraintestinales graves asociadas.
    -Fracaso anterior a adalumumab, azatioprina o mercaptopurina como prevención de recurrencia postquirúrgica.
    -Cualquier otra enfermedad o condición del paciente por la que, a juicio del investigador, no es adecuada la participación del paciente en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    -Indice de recurrencia endoscópica en la Enfermedad de Crohn tras 52 semanas de tratamiento utilizando el índice de Rutgeerts, definiendo la recurrencia como un índice de 2b, 3 ó 4.
    E.5.1.1Timepoint(s) of evaluation of this end point
    52 semanas
    E.5.2Secondary end point(s)
    -Porcentaje de pacientes en remisión clínica tras 24 y 52 semanas de tratamiento con Adalimumab o Azatioprina utilizando como variable de medida el Índice de Actividad de la Enfermedad de Crohn (CDAI), considerando como inactividad una puntuación menor o igual 200.
    -Entero-RM en la semana 52.
    -Porcentaje de pacientes que requieren hospitalización en la semana 52.
    -Cambios en los marcadores de actividad de la enfermedad, tales como calprotectina fecal, proteína C reactiva y VSG en las semanas 24 y 52.
    -Porcentaje de pacientes que requieren cirugía hasta la semana 52.
    -Cambios en la calidad de vida (medidos por los indices SIBDQ y Euro QoL) en las semanas 24 y 52.
    -Acontecimientos adversos con Adalimumab o Azatioprina.
    E.5.2.1Timepoint(s) of evaluation of this end point
    52 semanas
    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 Yes
    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 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) 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 Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Azatioprina
    E.8.2.4Number of treatment arms in the trial2
    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 concerned26
    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 No
    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
    No aplica
    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 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 No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 84
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state84
    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)
    Not apply
    No aplica
    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 Decision2011-12-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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