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    Summary
    EudraCT Number:2016-001170-15
    Sponsor's Protocol Code Number:CECUM
    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:2017-08-02
    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 number2016-001170-15
    A.3Full title of the trial
    Efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course
    in comparison with monotherapy oral corticosteroid course for moderate flares of ulcerative colitis: a randomized multicentre clinical trial
    Eficacia de los bolos intravenosos de corticoides más tratamiento con corticoides orales en comparación con corticoides orales en monoterapia para el tratamiento de la colitis ulcerosa moderada: ensayo clínico multicéntrico y aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Intravenous corticosteroids in moderate ulcerative colitis
    Corticoides Endovenosos en la Colitis Ulcerosa Moderada
    A.3.2Name or abbreviated title of the trial where available
    CECUM
    CECUM
    A.4.1Sponsor's protocol code numberCECUM
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02921555
    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 (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 supportGETECCU
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGETECCU (Grupo Español de Trabajo en Enfermedad de Crohn y Colitis ulcerosa)
    B.5.2Functional name of contact pointSecretaria Cientifica
    B.5.3 Address:
    B.5.3.1Street AddressEdifici IGTP, Carretera de Can Ruti, Camí de les escoles, s/n, Campus Can Ruti,
    B.5.3.2Town/ cityBadalona
    B.5.3.3Post code08916
    B.5.3.4CountrySpain
    B.5.4Telephone number0034635899553
    B.5.6E-mailsecretariacientifica2@geteccu.org
    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 Urbason
    D.2.1.1.2Name of the Marketing Authorisation holderSanofi Aventis 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 Concentrate for solution for infusion
    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 INNmethylprednisolone
    D.3.9.1CAS number 2375-03-3
    D.3.9.2Current sponsor code50537
    D.3.9.3Other descriptive nameMETHYLPREDNISOLONE SODIUM HEMISUCCINATE
    D.3.9.4EV Substance CodeSUB26423
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    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.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
    Moderate flares of Ulcerative Colitis
    Colitis ulcerosa con actividad moderada
    E.1.1.1Medical condition in easily understood language
    Inflammatory bowel disease
    enfermedad intestinal inflamatoria
    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
    To determine the efficacy of high-dose corticosteroid pulses added to conventional oral corticosteroid course for moderate flares of ulcerative colitis.
    Comparar la eficacia a corto y largo plazo de la adición de 3 bolos de 0,5g de metilprednisolona a un curso convencional de corticoides orales (prednisona) para el tratamiento de brotes moderados de colitis ulcerosa.
    E.2.2Secondary objectives of the trial
    - Clinical response
    - Biological response
    - Rate of adverse events
    - Rate of serious adverse events
    - Proportion of patients with clinical recurrence
    - Time to clinical relapse
    - Risk of hospitalization
    - Time to corticodependency
    - Number of participants with surgery events
    - Proportion of patients with corticodependency criteria
    •Respuesta clínica a los 3 y 7 días.
    •Respuesta biológica (PCR, calprotectina) a los 3, 7 días, 2 meses y 12 meses.
    •Tasa de efectos adversos.
    •Tasa de efectos adversos graves.
    •Proporción de pacientes con recidiva clínica.
    •Tiempo hasta la recidiva clínica.
    •Necesidad de hospitalización.
    •Proporción de pacientes que desarrollan criterios de corticodependencia.
    •Tiempo hasta el desarrollo de corticodependencia.
    •Necesidad y tiempo de cirugía.
    •Identificación de parámetros predictivos de respuesta a corticoides
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Ulcerative colitis diagnosis by Lennard-Jones criteria
    - ≥18 years
    - Left or extended extent of disease
    - Moderate flares of ulcerative colitis according to disease activity index (DAI)
    - No maintenance therapy or 5ASA treatment
    - The patient is available to understand study procedures and to sign the inform consent form
    - Inform Consent Form
    1) Diagnóstico de Colitis Ulcerosa según criterios de la European Crohns and Colitis Organisation
    2) Paciente mayor de 18 años
    3) Extensión de la enfermedad izquierda o extensa (afectación >25cm desde el margen anal)
    4) Brote moderado según Índice de Mayo (puntuación ≥ 6 y ≤10)
    5) Sin tratamiento de mantenimiento o con 5-ASA oral y/o tópico
    6) El paciente tiene la capacidad de comprender los requerimientos del estudio y proporcionar un consentimiento informado
    7) Consentimiento Informado firmado
    E.4Principal exclusion criteria
    - Previous or current thiopurines, methotrexate or biological treatment
    - Administration of systemic corticoids the last 6 months
    - Acute or moderate systemic infection
    - Diabetes mellitus or arterial hypertension
    - Pregnancy or breastfeeding
    - Allergic reactions associated to corticosteroids therapy
    1) Exposición previa o tratamiento actual con tiopurinas, calcineurínicos, metotrexato y/o agentes biológicos
    2) Administración de corticoides sistémicos en los últimos 6 meses (sin incluir los corticoides orales de acción tópica)
    3) Infección sistémica grave activa o no controlada, enfermedades o condiciones médicas graves que puedan interferir con la elegibilidad del paciente o con el tratamiento
    4) Diabetes mellitus o hipertensión arterial no controladas
    5) Enfermedad psiquiátrica o cualquier otra enfermedad no controlada que contraindique el tratamiento esteroideo
    6) Embarazo o lactancia o voluntad de gestación en el periodo de participación en el estudio
    7) Historia de reacciones alérgicas atribuidas a corticoides
    E.5 End points
    E.5.1Primary end point(s)
    Clinical Remission :
    The proportions of patients with steroid-free, clinical and endoscopic remission, with no rescue therapies.
    It will be measured as Mayo index score ≤ 2 points with any single variable >1.
    Remisión clínica: Índice de Mayo inferior o igual 2 puntos sin ninguna variable individual superior 1
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8 and week 54
    Semana 8 y semana 54
    E.5.2Secondary end point(s)
    - Clinical response
    - Early clinical response
    - Endoscopic remission
    - Relapse,
    - Corticodependence
    - Rescue treatment:
    Respuesta clínica: disminución del índice de Mayo de al menos 3 puntos y de al menos el 30% con una disminución de la variable de sangrado rectal de al menos 1 punto o con un valor absoluto de 0 o 1.
    Respuesta clínica precoz: disminución del subíndice clínico de Mayo de al menos 3 puntos y de al menos el 30% con una disminución de la variable de sangrado rectal de al menos 1 punto o con un valor absoluto de 0 o 1, a los 7 días de tratamiento con corticoides.
    Remisión endoscópica: subíndice endoscópico de Mayo de 0 o 1.
    Recidiva: reaparición de síntomas definido como un subíndice clínico de Mayo superior a 2.
    Corticodependencia: recidiva durante la reducción de dosis de prednisolona o durante los 3 meses siguientes a la suspensión del tratamiento esteroideo.
    Tratamiento de rescate: reinicio o incremento de la dosis establecida de corticoides (incluidos los corticoides orales de acción tópica) o inicio de cualquier tratamiento para el tratamiento de la colitis ulcerosa distinto de la mesalazina, incluyendo agentes biológicos (infliximab, adalimumab, golimumab, vedolizumab), calcineurínicos (ciclosporina, tacrolimus), tiopurinas (azatioprina, mercaptopurina), metotrexato, leucoaféresis o colectomía.
    E.5.2.1Timepoint(s) of evaluation of this end point
    week 8 and week 54
    day 3, day 7, week 8 and week 54
    -Semana 8 y semana 54
    - Dia 3, dia 7, semana 8 y semana 54
    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 No
    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) No
    E.7.4Therapeutic use (Phase IV) Yes
    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.8.2.3.1Comparator description
    prednisona
    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 concerned34
    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
    LVLS
    Última visita del último paciente en el estudio
    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
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 148
    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 state148
    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)
    None
    Ninguno
    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 Decision2017-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-29
    P. End of Trial
    P.End of Trial StatusOngoing
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