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    Summary
    EudraCT Number:2015-000555-24
    Sponsor's Protocol Code Number:2015-100752
    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:2016-07-15
    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 number2015-000555-24
    A.3Full title of the trial
    Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Efficacy and Safety of Vedolizumab in Prevention of Endoscopic Recurrence of Crohn's Disease in Patients with Ileo-colonic Surgical Resection and Ileocolonic Anastamosis : REPREVIO (recurrence prevention with Entyvio)
    Estudio multicéntrico, aleatorizado, controlado con placebo, doble-ciego, para determinar la seguridad y eficacia de Vedolizumab en la prevención de la recurrencia endoscópica en la enfermedad de Crohn, en pacientes previamente sometidos a resección quirúrgica y anastomosis ileocólicas: REPREVIO (prevención de la recurrencia con Entyvio.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Determine the Effectiveness and Safety of Vedolizumab in Prevention of Recurrence of Crohn's Disease of the mucosa in Patients with Surgical Removel of the area between the small and the large bowel.
    Estudio multicéntrico, aleatorizado, controlado con placebo, doble-ciego, para determinar la seguridad y eficacia de Vedolizumab en la prevención de la recurrencia endoscópica en la enfermedad de Crohn, en pacientes previamente sometidos a extirpación quirúrgica del área entre el intestino delgado y el grueso.
    A.3.2Name or abbreviated title of the trial where available
    REPREVIO
    REPREVIO
    A.4.1Sponsor's protocol code number2015-100752
    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 SponsorAcademic Medical Center Amsterdam
    B.1.3.4CountryNetherlands
    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 supportTakeda
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAcademic Medical Center
    B.5.2Functional name of contact pointIBD trialcenter
    B.5.3 Address:
    B.5.3.1Street AddressMeibergdreef 9
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1105 AZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205666545
    B.5.5Fax number0031205669285
    B.5.6E-maile.clasquin@amc.uva.nl
    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 Entyvio
    D.2.1.1.2Name of the Marketing Authorisation holderTakeda Pharma A/S
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 nameVedolizumab IV
    D.3.2Product code MLN0002
    D.3.4Pharmaceutical form Powder for 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 INNvedolizumab
    D.3.9.1CAS number 943609-66-3
    D.3.9.2Current sponsor codeMLN0002
    D.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number60
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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) Yes
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate and solvent for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Crohn's disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's disease
    La enfermedad de Crohn es una enfermedad crónica de origen desconocido, en la cual el sistema inmunitario del individuo ataca su propio intestino produciendo inflamación.
    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
    The primary objective of this prospective placebo-controlled study is to assess the ability of vedolizumab to prevent postoperative endoscopic recurrence of Crohn’s disease in the neoterminal ileum.
    El objetivo primario de este estudio prospectivo controlado con placebo es valorar la capacidad de vedolizumab para prevenir la recurrencia endoscópica postoperatoria de la enfermedad de Crohn en el íleon terminal
    E.2.2Secondary objectives of the trial
    Prevention of clinical recurrence of Crohn’s disease
    Prevención de la recurrencia clínica de la enfermedad de Crohn
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements.
    - The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Consent must be documented.
    - Established Crohn’s disease as the indication for ileocolonic resection
    - Age > 18
    - Ileocolonic resection with ileocolonic anastomosis and removal of all tissue macroscopically affected by CD according to the surgeon
    - Presence of at least 1 risk factor for recurrence:
    o Active smoking > 10 cigarettes/day
    o 2nd, 3rd or later resection
    o Surgery for perforating complication (abscess, fistula)
    o Previous exposure to anti-TNF antibodies
    - Male or non-pregnant, non-lactating females. Females of child bearing potential must have a negative serum pregnancy test prior to randomization, and must use a hormonal (oral, implantable or injectable) or barrier method of birth control throughout the study. Females unable to bear children must have documentation of such in the source records (i.e., tubal ligation, hysterectomy, or post-menopausal [defined as a minimum of one year since the last menstrual period]).
    - Anti-TNF discontinued for at least 6 weeks before screening
    Según el criterio del investigador, el paciente es capaz de comprender y cumplir con los requisitos del protocolo
    - El sujeto firma y fecha un consentimiento informado escrito con sus correspondientes autorizaciones de uso de datos, antes de iniciar cualquier procedimiento del estudio. El consentimiento debe ser documentado.
    - Enfermedad de Crohn establecida como la indicación para la resección ileocólica
    - Edad > 18
    - Resección ileocólica con anastomosis ileocólica y eliminación de todo el tejido macroscópicamente afectado por la enfermedad de Crohn, según el parte quirúrgico
    -Presencia de al menos un factor de riesgo para la recurrencia:
    o Fumador activo: > 10 cigarrillos al día
    o Segunda, tercera o posterior resección
    o Resección por complicación perforante (absceso, fístula)
    o Exposición previa a anticuerpos anti-TNF
    -Varones o mujeres no embarazadas ni en periodo de lactancia. Las mujeres en edad fértil deben presentar una prueba de embarazo en suero negativa, antes de la aleatorización y usar un método hormonal (oral, implante o inyectable) o anticonceptivo de barrera durante el estudio. Las mujeres que no sean capaces de tener hijos (por ejemplo: ligadura de trompas, histerectomía o post menopausia (definida como un mínimo de 1 año desde el último periodo menstrual) deben tener esto documentado en los documentos fuente.
    - Anti-TNF suspendido al menos 6 semanas antes de la selección
    E.4Principal exclusion criteria
    - Patients that need to continue postoperative medication for their CD as per investigator's discretion, eg for fistulizing perianal CD.
    - Previous treatment with VDZ
    - Clinically significant CD elsewhere in the gastrointestinal tract not removed with surgery
    - Patients with clinically documented short bowel syndrome.
    - Patients with a history of cancer (other than resected cutaneous basal or squamous cell carcinoma or in situ cervical cancer) with less than 2 disease-free documented years.
    - Patients with the following laboratory abnormalities:
    White blood count < 3 x 109/L
    Lymphocyte count < 0.5 x 109/L
    Hemoglobin < 8 g/dL
    Platelet count < 125 x 109/L or > 800 x 109/L
    ALT or AST > 3.0 times the upper limit of normal (ULN)
    Alkaline Phosphatase > 2.0 times the ULN
    Serum Creatinine > 2 times the ULN
    Prothrombin time (INR) > 1.5 times normal
    - Active participation in another trial.
    - Evidence of Clostridium difficile infection in the previous 4 weeks.
    - Patients with abdominal abscess, active or latent tuberculosis or cancer.
    - A history of alcohol or illicit drug use that in the opinion of the principal investigator (PI) would interfere with study procedures.
    - Patients with psychiatric problems that in the opinion of the PI would interfere with study procedures.
    - Patients unable to attend all study visits.
    - Patients with a history of non-compliance with clinical study protocols.
    - Contraindication for endoscopy.
    - History of colonic dysplasia/cancer
    - Received other biologics within the last 6 weeks of screening
    - Known HIV, chronic hepatitis B or C infection
    - Evidence of or treatment for C. difficile infection or other intestinal pathogen at screening
    Pacientes que necesiten continuar con medicación post operatoria para su enfermedad de Crohn, según criterio del investigador, por ejemplo, enfermedad de Crohn perianal fistulizante.
    -Tratamiento previo con VDZ (vedolizumab)
    -Enfermedad de Crohn clínicamente significativa en otras partes del tracto gastrointestinal que no se haya eliminado con la cirugía.
    -Pacientes con síndrome de intestino corto clínicamente documentado.
    -Pacientes con historia de cáncer con menos de 2 años libres de enfermedad documentados (exceptuando epitelioma basal o espinocelular resecado, o cáncer cervical in situ).
    -Pacientes con las siguientes anomalías de laboratorio:
    oRecuento de glóbulos blancos < 3 x 109 /L
    oRecuento de linfocitos < 0.5 x 109 /L
    oHemoglobina < 8g /dL
    oRecuento de plaquetas < 125 x 109 /L o > 800 x 109 /L
    oALT o AST > 3 veces el límite superior de la normalidad (ULN)
    oFosfatasa Alcalina > 2 veces el límite superior de la normalidad
    oCreatinina sérica > 2 veces el límite superior de la normalidad
    oTiempo de protrombina (INR) > 1.5 veces el límite superior dela normalidad

    -Participación activa en otro ensayo clínico.
    -Pacientes con absceso abdominal, tuberculosis activa o latente o cáncer.
    -Alcoholismo o drogadicción, que en opinión del investigador, pudieran interferir en el cumplimiento de los procedimientos del estudio por parte del paciente.
    -Pacientes con problemas psiquiátricos que, según criterio del investigador, pudieran interferir en la capacidad del paciente para cumplir con los procedimientos del estudio.
    -Pacientes incapaces de asistir a todas las visitas del estudio.
    -Pacientes con historia de incumplimiento con los protocolos de estudios clínicos.
    -Contraindicación para endoscopia.
    -Antecedentes de displasia de colon y/o cáncer de colon.
    -Haber recibido otros biológicos dentro de las últimas 6 semanas del periodo de selección.
    -Infección por el VIH, Hepatitis B o Hepatitis C.
    -Evidencia o de tratamiento para infección por C. Difficile u otro patógeno intestinal dentro de las 4 semanas previas al reclutamiento o a la selección
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of patients with severe endoscopic postoperative recurrence of CD (Rutgeerts i2b, i3 or i4) after approximately 6 months (Week 26).
    Proporción de pacientes con recurrencia postoperatoria endoscópica grave de enfermedad de Crohn (Rutgeerts i2b, i3 o i4) después de aproximadamente 6 meses (Semana 26)
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 26
    Semana 26
    E.5.2Secondary end point(s)
    1. The proportion of patients with any endoscopic recurrence of CD (Modified Rutgeerts Grade > i0) after 6 months.
    2. Changes in the CDAI (Crohn’s disease activity index) between week 0 and 26. This measure will give an indication for clinical recurrence. Although most patients will remain asymptomatic, we will collect global scores as well as individual components.
    3. Adverse events and serious adverse events
    4. Quality of life measure with a disease-specific instrument (IBDQ) and a generic QoL instrument (SF-36).
    5. Serum concentrations of vedolizumab and antibodies to vedolizumab before every infusion
    1. La proporción de pacientes con alguna recurrencia endoscópica de enfermedad de Crohn (Grado Rutgeerts modificado >i0) después de 6 meses.
    2.CAmbios en el CDAI (Indice de actividad de la enfermedad de Crohn) entre la semana 0 y 26. Esta medida dará una indicación para la recurrencia clínica. Aunque la mayoría de los pacientes permanecerán asintomáticos, recogeremos puntuaciones globales así como componentes individuales.
    3. Acontecimientos adversos ya acontecimientos adversos graves .
    4. Medida de calidad de vida con un instrumento específico de la enfermedad (IBDQ) y un instrumento de calidad de vida genérico (SF-36)
    5. Concentraciones séricas de vedolizumab y anticuerpos para vedolizumab antes de cada infusión
    E.5.2.1Timepoint(s) of evaluation of this end point
    secondary endlpoint 1,2 and 4 at week 26
    Secondary endpoint 3 and 5 at all time points
    objetivo secundario 1, 2 y 4 en la semana 26
    Objetivo secundario 3 y 5 en todo momento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    E.8.2.3Other No
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA13
    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
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 60
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    Will be discussed with the subject on an individual basis
    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 Decision2016-08-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-08-04
    P. End of Trial
    P.End of Trial StatusOngoing
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