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    Summary
    EudraCT Number:2012-000729-28
    Sponsor's Protocol Code Number:GA28084
    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:2012-04-17
    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 number2012-000729-28
    A.3Full title of the trial
    MULTICENTER STUDY IN PATIENTS WITH CROHN?S DISEASE FOR CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY ASSAYS FOR ASSESSMENT OF DISEASE ACTIVITY
    Estudio multicéntrico en pacientes con enfermedad de Crohn para la caracterización de las pruebas con enterografía por resonancia magnética en la evaluación de la actividad de la enfermedad.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Imaging study in patients with Crohn`s Disease
    Estudio con técnicas de imagen en pacientes con enfermedad de Crohn
    A.4.1Sponsor's protocol code numberGA28084
    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 SponsorGenentech, 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 supportGenentech, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGenentech, Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address1 DNA Way
    B.5.3.2Town/ citySouth San Francisco
    B.5.3.3Post codeCA 94080-4990
    B.5.3.4CountryUnited States
    B.5.4Telephone number0016504671687
    B.5.5Fax number0016504672322
    B.5.6E-mailsobyrne@gene.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.2.5The 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 name/
    D.3.2Product code /
    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 INNÁCIDO GADOBÉNICO
    D.3.9.1CAS number 113662-23-0
    D.3.9.2Current sponsor codeNA
    D.3.9.3Other descriptive nameNA
    D.3.9.4EV Substance CodeSUB07860MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mmol/kg millimole(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.1
    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
    Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease
    Investigación de la enterografía por resonancia magnética con/sin contraste para la evaluación del estadío de la enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Investigation of magnetic resonance enterography (MRE) with/without dye for evaluation of disease status in Crohn's disease
    Investigación de la enterografía por resonancia magnética con/sin contraste para la evaluación del estadío de la enfermedad de Crohn
    E.1.1.2Therapeutic area Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level HLGT
    E.1.2Classification code 10017969
    E.1.2Term Gastrointestinal inflammatory conditions
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To estimate the test-retest reliability (precision) of MRE assessments of CD activity in the small bowel in a global setting
    Calcular la fiabilidad prueba-reprueba (precisión) de las evaluaciones por ERM de la actividad de la EC en el intestino delgado en un ámbito global.
    E.2.2Secondary objectives of the trial
    - To establish the correlation between MRE and ileocolonoscopy as an assessment of CD activity in the colon in a global setting
    - To assess the impact of the use of colonic contrast on MRE assessment of CD activity in the colon
    - To establish a standardized CD MRE technical protocol that is feasible to use in a global setting
    - To confirm that high-quality MRE data can be obtained across six investigational sites
    - Establecer la correlación entre ERM e ileocolonoscopia como métodos de evaluación de la actividad de la EC en el colon en un ámbito global.
    - Evaluar el efecto del uso de contraste colónico en la evaluación por ERM de la actividad de la EC en el colon.
    - Establecer un protocolo técnico normalizado de ERM en la EC cuyo uso sea factible en un ámbito global.
    - Confirmar que pueden obtenerse datos de ERM de alta calidad en seis centros de investigación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Signed Informed Consent Form
    - Age >or= 18 years
    - Confirmed histologic diagnosis of CD and a disease duration of >or= 12 weeks (after first diagnosis by a physician)
    - Clinical indication for the performance of MRE, with or without contrast
    - On a stable dose of medication for CD for a defined period of time prior
    to study entry, as outlined below:
    - Stable dose of 5-aminosalicylic acid preparations (oral or rectal)
    for 4 weeks prior to Day 1
    - Stable dose of corticosteroid medication (oral or rectal) for 2 weeks prior to Day 1
    - Stable dose of immunosuppressive therapy (6-mercaptopurine,
    azathioprine, or methotrexate) for 3 months prior to Day 1
    - Stable dose of anti-TNF therapy for 8 weeks prior to Day 1
    - CDAI score within pre-specified range
    - Estimated GFR >or= 30-60 mL/min/1.73 m2, as estimated from serum
    creatinine levels
    - Documento de consentimiento informado firmado.
    - Edad >ó= 18 años.
    - Diagnóstico de EC confirmado histológicamente y duración de la enfermedad >ó= 12 semanas (desde el diagnóstico por un médico).
    - Indicación clínica para la realización de una ERM, con o sin contraste
    - En tratamiento con una dosis estable de medicación para la EC durante un período de tiempo establecido antes de la entrada en el estudio, tal como se indica a continuación:
    Preparados de ácido 5-aminosalicílico (por vía oral o rectal) en dosis estable durante las 4 semanas anteriores al día 1.
    Corticosteroides (por vía oral o rectal) en dosis estable durante las 2 semanas anteriores al día 1.
    Inmunosupresores (6-mercaptopurina, azatioprina, o metotrexato) en dosis estable durante los 3 meses anteriores al día 1.
    Fármacos anti-TNF en dosis estable durante las 8 semanas anteriores al día 1.
    - Puntuación CDAI dentro de los límites preestablecidos (véase la tabla 1).
    - Tasa de FG estimada >ó= 30-60 ml/min/1,73 m2, calculada a partir de la concentración de creatinina sérica.
    E.4Principal exclusion criteria
    - Requirement for hospitalization due to severity of CD
    - Inability to comply with study protocol
    - Lack of peripheral venous access
    - Contraindications to MRI, including non?MRI-compatible medical or dental implants, other ferromagnetic metal objects in the body, severe
    claustrophobia, very large tattoos, inability to lie still in a supine position
    for up to 40 minutes, or inability to meet local imaging site MRI eligibility
    requirements based on safety screening procedures
    - Pregnant or lactating
    - Significant uncontrolled disease, such as cardiac, pulmonary, renal, hepatic, endocrine, neurological, gastrointestinal, or hematologic disorders, that would contraindicate an ileocolonoscopy or MRE scan
    - Distal colonic strictures on ileocolonoscopy that prevent traverse of
    the colonoscope
    - History of severe allergic, anaphylactic, or other hypersensitivity reactions to imaging contrast agents
    - Clear symptoms of bowel obstruction
    - Necesidad de hospitalización debido a la gravedad de la EC.
    - Incapacidad para cumplir el protocolo del estudio.
    - Acceso venoso periférico no disponible.
    - Contraindicaciones para la RM, tales como implantes médicos o dentales no compatibles con la RM, otros objetos metálicos ferromagnéticos en el cuerpo, claustrofobia grave, tatuajes de tamaño muy grande, incapacidad para permanecer inmóvil en decúbito supino durante 40 minutos, o imposibilidad de cumplir los requisitos de elegibilidad para la RM del centro de imagen según los procedimientos de selección en relación con la seguridad.
    - Embarazo o lactancia.
    - Enfermedades importantes no controladas, tales como trastornos cardíacos, pulmonares, renales, hepáticos, endocrinos, neurológicos, digestivos o hematológicos, que supongan una contraindicación a la ileocolonoscopia o la ERM.
    - Estenosis del colon distal que impidan el avance del colonoscopio durante la ileocolonoscopia.
    - Antecedentes de reacciones graves alérgicas, anafilácticas o de hipersensibilidad a los medios de contraste.
    - Síntomas claros de obstrucción intestinal.
    E.5 End points
    E.5.1Primary end point(s)
    The outcome measures for this study are as follows:
    - MRE-derived MaRIA scores from small bowel and colon segments
    - Compliance with the MRE technical protocol for patient preparation and scanning, as specified in the imaging review charter
    - MRE image quality, as specified in the imaging review charter
    - Ileocolonoscopy-derived CDEIS score and SES CD
    - CDAI score
    - Serum or plasma biomarkers, including but not limited to C-reactive protein
    En este estudio, los criterios de valoración son los siguientes:
    - Puntuaciones MaRIA basadas en la ERM de segmentos del intestino delgado y el colon.
    - Cumplimiento del protocolo técnico de ERM en cuanto a la preparación y la exploración del paciente, con arreglo a lo establecido en el estatuto de revisión de los estudios de imagen.
    - Calidad de las imágenes de ERM, según se especifica en el estatuto de revisión de los estudios de imagen.
    - Puntuación CDEIS basada en la ileocolonoscopia y puntuación SES EC.
    - Puntuación CDAI
    - Biomarcadores séricos o plasmáticos, incluyendo, entre otros, la proteína C reactiva.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As Necessary
    Según sea necesario
    E.5.2Secondary end point(s)
    Not Applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not Applicable
    No aplica
    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 No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    CHARACTERIZATION OF MAGNETIC RESONANCE ENTEROGRAPHY
    ASSAYS FOR ASSESSMENT OF CROHN`S DISEASE
    Caracterización de la enterografía por resonancia magnética para la evaluación de la enfermedad de Crohn
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.4Number of treatment arms in the trial1
    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.8.4.1Number of sites anticipated in Member State concerned1
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA3
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Spain
    United States
    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
    Study completion will occur 48 hours after the final MRE scan is performed.
    La finalización del estudio será 48 horas después de realizar la última exploración de ERM.
    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 months5
    E.8.9.1In the Member State concerned days15
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days15
    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: 44
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 27
    F.4.2.2In the whole clinical trial 54
    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)
    Patients will continue on their prescribed medication during and after the study.
    Los pacientes seguirán tomando su medicación prescrita durante y después del estudio
    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 Decision2012-06-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-08
    P. End of Trial
    P.End of Trial StatusOngoing
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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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