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    Summary
    EudraCT Number:2007-003815-30
    Sponsor's Protocol Code Number:Ada-UC-07-102
    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:2007-10-24
    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 number2007-003815-30
    A.3Full title of the trial
    Estudio abierto, randomizado, multicéntrico para comparar la eficacia y la seguridad de la prednisona y granulocitoféresis con Adacolumn® versus la prednisona sola en el tratamiento de pacientes con colitis ulcerosa activa corticodependiente leve a moderada.
    A.4.1Sponsor's protocol code numberAda-UC-07-102
    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 SponsorGETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa)
    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 DACORTIN
    D.2.1.1.2Name of the Marketing Authorisation holderMERCK FARMA Y QUIMICA,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 namePREDNISONE
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPHemodialysis
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPREDNISONE
    D.3.9.1CAS number N/A
    D.3.9.2Current sponsor codeN/A
    D.3.9.3Other descriptive nameN/A
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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
    Colitis ulcerosa corticodependiente leve o moderada
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluación de la eficacia y la seguridad de 7 tratamientos GMA (adsorción de granulocitos y monocitos) con Adacolumn durante 7 semanas consecutivas (1/semana) en combinación con la prednisona comparado con un tratamiento con prednisona sola para la inducción y mantenimiento de la remisión de la colitis ulcerosa corticodependiente durante un periodo de 24 semanas.
    E.2.2Secondary objectives of the trial
    N/A
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - 18-75 años
    - Colitis ulcerosa activa con síntomas clínicos y resultados endoscópicos confirmados
    - Actividad de la CU definida por Mayo score ≥ 4 y ≤ 10 con al menos 1 punto en la sigmoidoscopia flexible
    - Dependencia de corticoesteroides definida por:
    A. incapacidad para interrumpir el tratamiento con corticoesteroides en los 3 meses del inicio del tratamiento, sin enfermedad activa recurrente o
    B. recaída clínica en los 3 meses posteriores a la retirada de los corticoesteroides.
    - Afectación del colon con colitis ulcerosa con una extensión de más de 15 cm desde el margen anal.
    - Dosis estables:
    A. Aminosalicilatos en las últimas 4 semanas
    B. Prednisolona o dosis equivalente ≤ 20 mg/día en las últimas 2 semanas
    C. Azatioprina o 6-mercaptopurina a dosis estables en las últimas 12 semanas
    - Formulario de consentimiento informado firmado
    - Estar de acuerdo en acudir a las visitas de seguimiento programadas
    - Capacidad de completar el diario
    E.4Principal exclusion criteria
    -Fiebre (≥ 38ºC)
    -Indicios de megacolon tóxico
    -Intervención quirúrgica programada antes de 24 semanas
    -Enfermedades obstructivas conocidas del tracto gastrointestinal
    -Proctocolectomía, colectomía total, ileostomía, estoma o anastomosis ileoanal con reservorio
    -Antecedentes de reacciones alérgicas a la heparina o trombocitopenia inducida por la heparina
    -Antecedentes de reacciones alérgicas de hipersensibilidad asociadas con los procedimientos de aféresis o la intolerancia a dichos procedimientos.
    -Necesidad de utilizar un catéter venoso central para los tratamientos de aféresis
    -Infección conocida con patógenos intestinales, huevos patógenos ova o parásitos, toxina de C. difficile o CMV
    -Hipotensión (presión sistólica < 80 mmHg o presión diastólica < 50 mmHg) sólo en la visita de selección
    -Hipertensión inestable (presión sistólica >180 mmHg o presión diastólica > 120 mmHg) a pesar del tratamiento médico
    -Antecedentes de infarto de miocardio o angina inestable en los 6 meses anteriores
    -Antecedentes de revascularización coronaria o angioplastias en los 6 meses anteriores
    -Prótesis valvular, marcapasos o cualquier otro implante permanente
    -Enfermedad vascular periférica o cardiovascular grave, nefropatía grave
    -Hepatopatías definidas por niveles de SGOT [AST], SGPT [ALT] o fosfatasa alcalina > 2,5 veces el límite superior normal del laboratorio que realiza los análisis
    -Antecedentes de cirrosis
    -Trastornos hemorrágicos (TP o TTP > 1,5 veces el límite superior normal del laboratorio que realiza los análisis) o tratamientos anticoagulantes concomitantes con otros fines distintos al del tratamiento de aféresis.
    -Antecedentes previos indicativos de un trastorno de hipercoagulación, incluyendo 1 o más episodios de embolia pulmonar o trombosis venosa profunda
    -Infección confirmada por hepatitis B o C o por VIH
    -Parámetros hematológicos anómalos definidos como anemia grave con hemoglobina < 8,5 g/dl, leucocitos <3500/μl y granulocitos < 2000/μl.
    -Niveles de fibrinógeno > 700 mg/dl
    -Intervención quirúrgica importante en los 6 meses anteriores
    -Infecciones:
    Infecciones activas aparecidas menos de cuatro semanas después de finalizar con éxito un tratamiento antibiótico para infecciones bacterianas habituales
    Infección vírica febril durante las cuatro semanas anteriores a la inclusión en el estudio clínico
    -Tratamiento para micosis sistémicas que finalice en las 12 semanas anteriores al inicio del estudio
    -Tumores malignos en los 2 años anteriores, exceptuando carcinomas cutáneos o displasia cervical (CIN I-II) curados mediante intervención quirúrgica
    -Antecedentes de displasia o cáncer de colon o falta de una colonoscopia completa en los últimos 12 meses en pacientes con CU desde hace tiempo (> 20 años)
    -Alcoholismo o toxicomanía actual
    -Embarazo, lactancia o embarazo previsto durante el transcurso del estudio
    -Uso, durante los 30 días anteriores, de cualquier producto farmacéutico, biológico o sanitario en fase de investigación clínica, o, en caso de saberlo, con un período inferior a 5 semividas
    -Haber recibido ciclosporina o tacrolimús en las ocho semanas anteriores a la inclusión en el estudio
    -Haber recibido infliximab en las ocho semanas anteriores a la inclusión en el estudio
    -Colitis ulcerosa fulminante
    E.5 End points
    E.5.1Primary end point(s)
    Variable principal de respuesta:
    Porcentaje de pacientes en remisión clínica libre de esteroides definida por Mayo score ≤ 2 y una subpuntuación de hemorragia rectal ≤ 1 en la semana 24

    Variables secundarias de respuesta:
    • Remisión libre de esteroides (evaluada por la Mayo score) en la semana 12
    • Respuesta en las semanas 12 y 24 (disminución de la Mayo score ≥ 3 puntos)
    • Cambios en los reactantes de fase aguda en todas las analíticas
    • Necesidad de tratamiento de rescate (nuevos ciclos de corticoesteroides, ciclosporina, infliximab o intervención quirúrgica) durante el periodo de estudio

    Variables de seguridad:
    • Acontecimientos adversos
    • Constantes vitales
    • Parámetros analíticos
    • Exploración física
    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 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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    ADACOLUMN
    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 concerned34
    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 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
    Cierre de la base de datos
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months24
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months24
    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) Information not present in EudraCT
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 232
    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 Decision2007-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2007-11-14
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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