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    Summary
    EudraCT Number:2019-000668-27
    Sponsor's Protocol Code Number:MBW-2017-01
    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:2019-07-04
    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 number2019-000668-27
    A.3Full title of the trial
    Pilot Project for the Treatment of Perianal Disease through the Local Injection of Remsima Guided by Ultrasound. Number of cases.
    Proyecto Piloto del Tratamiento de la Enfermedad Perianal Mediante la Inyección Local de Remsima Guiada por Ecografía. Serie de Casos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    TREATMENT OF PERIANAL DISEASE WITH LOCAL INJECTION OF REMSIMA GUIDED BY ULTRASOUND
    TRATAMIENTO DE LA ENFERMEDAD PERIANAL CON INYECCIÓN LOCAL DE REMSIMA GUIADO POR ECOGRAFÍA
    A.4.1Sponsor's protocol code numberMBW-2017-01
    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 SponsorMarta Maia Boscá Watts
    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 supportGrupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa: GETECCU
    B.4.2CountrySpain
    B.4.1Name of organisation providing supportSociedad Valenciana de Patología Digestiva: SVPD
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMarta Maia Boscá Watts
    B.5.2Functional name of contact pointMarta Maia Boscá Watts
    B.5.3 Address:
    B.5.3.1Street AddressAvenida de Blasco Ibáñez, 17
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46010
    B.5.3.4CountrySpain
    B.5.4Telephone number34961973820
    B.5.6E-mailmaiabosca@yahoo.es
    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 Remsima
    D.2.1.1.2Name of the Marketing Authorisation holderCelltrion Healthcare Hungary Kft.
    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 nameRemsima
    D.3.2Product code CT-P13
    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
    Rectal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNINFLIXIMAB
    D.3.9.1CAS number 170277-31-3
    D.3.9.4EV Substance CodeSUB02681MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number4.15
    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) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    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
    Perianal disease (PD): alteration associated with inflammatory bowel disease (IBD) that includes fissures, ulcers, fistulas or abscesses, and is one of the most difficult aspects of treating IBD. Both by direct affectation of the sphincters and by the repeated surgeries that may be necessary to avoid septic conditions, there may be pain and incontinence to gases and feces, which supposes an important reduction of the quality of life of the patients.
    Enfermedad perianal (EPA): alteración asociada a la enfermedad inflamatoria intestinal (EII) que engloba desde fisuras, a úlceras, fístulas o abscesos, y constituye uno de los aspectos más difíciles de tratar de la EII. Tanto por afectación directa de los esfínteres como por las repetidas cirugías que pueden ser necesarias para evitar cuadros sépticos, puede haber dolor e incontinencia a gases y heces, lo que supone una importante merma de la calidad de vida de los pacientes.
    E.1.1.1Medical condition in easily understood language
    Perianal disease consists of anomalies in the area of the anus and rectum (such as fissures, fistulas, abscesses) that can cause complications (pain, incontinence to gas or feces).
    La enfermedad perianal consiste en anomalías en la zona del ano y el recto (como fisuras, fístulas, abscesos) que pueden provocan complicaciones (dolor, incontiencia a gases o heces).
    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 evaluate the efficacy (clinical and radiological remission in week 24) of the injection guided by ultrasound of anti-TNF in the treatment of the PD. Combined remission in week 24 (clinical and radiological) is considered the clinical observation of the closure of all external orifices that drained at baseline (clinical remission is defined as the closure of all external fistulous orifices that drained in the basal study when compressed with the fingers) and the absence of collections greater than 2 cm in the treated fistulous trajectories confirmed by Magnetic Resonance (MR).
    - To improve the local anti-TNF injection technique by using endoanal ultrasound and performing the procedure on an outpatient basis, in the endoscopy unit, with sedation.
    -Evaluar la eficacia (remisión clínica y radiológica en la semana 24) de la inyección guiada por ecografía de anti-TNF en el tratamiento de la EPA. Se considera remisión combinada en la semana 24 (clínica y radiológica) la observación clínica del cierre de todos los orificios externos que drenaban en el momento basal (la remisión clínica se define como el cierre de todos los orificios fistulosos externos que drenaban en el estudio basal al comprimirlos con los dedos) y la ausencia de colecciones mayores de 2 cm en los trayectos fistulosos tratados confirmada por Resonancia Magnética (RM).
    -Mejorar la técnica de inyección de anti-TNF local mediante el uso de la ecografía endoanal y la realización del procedimiento de forma ambulatoria, en la unidad de endoscopias, con sedación.
    E.2.2Secondary objectives of the trial
    -To evaluate the clinical response (defined as the closure of at least 50% of all external orifices that drained in the baseline study) in week 24.
    -To quantify (in week 24) the improvement in the PDAI, CDAI and IBDQ.
    -Time (in weeks) when combined remission is achieved
    -Time (in weeks) when a relapse occurs.
    -To observed side effects, related to the drug or related to the procedure.
    -To evaluate the number of surgical interventions.
    -Evaluar la respuesta clínica (definida como el cierre de cómo mínimo el 50% de todos los orificios externos que drenaban en el estudio basal) en la semana 24.
    -Cuantificar (en la semana 24) la mejoría en el PDAI, CDAI y IBDQ.
    -Tiempo (en semanas) en que se consigue la remisión combinada
    -Tiempo (en semanas) en que se produce una recaída.
    -Efectos secundarios observados, relacionados con el fármaco o relacionados con el procedimiento.
    -Evaluar el número de intervenciones quirúrgicas.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Patients diagnosed with Crohn's disease with complex PD.
    -Older than 18 years-old.
    -EPA with no response, or partial response at the discretion of the clinician, to usual medical treatment and / or drainage of abscesses, treatment of fistulas and / or placement of perianal setons.
    -PD with less than two internal holes and three external holes.
    -PDAI> 4.
    - Absence of rectal involvement or mild endoscopic activity (SES-CD <5).
    - Willing to enter the study and sign the informed consent.
    -Pacientes con diagnóstico de enfermedad de Crohn con EPA compleja.
    -Mayor de 18 años.
    -EPA con ausencia de respuesta, o respuesta parcial, a criterio del clínico, a tratamiento médico habitual y/o cirugía de drenaje de abscesos, tratamiento de fístulas y/o colocación de sedales perianales.
    -EPA con menos de dos orificios internos y tres orificios externos.
    -PDAI > 4.
    -Ausencia de afectación rectal o actividad endoscópica leve (SES-CD <5).
    -Voluntad de entrar en el estudio y firma del consentimiento informado.
    E.4Principal exclusion criteria
    -Patients with PD not associated with IBD.
    -Patients with moderate or severe allergic reactions due to anti-TNF.
    -PD with more than two internal holes or three external holes.
    -Rectovaginal fistulas.
    -Moderate or severe proctitis.
    -Anal or rectal stenosis that prevents an endoscopic ultrasound.
    -Patients with more than two fistulous trajectories.
    -Patients with perianal abscesses not drained of more than 2 cm.
    -PDAI <4.
    -Patients receiving specific local treatments for perianal disease such as stem cell injection. It must have been more than a year since the patient was treated with stem cells to be included in this study.
    -Definitive ileostomy carrier.
    -Pregnancy or breastfeeding, or desire for it during next year.
    -Recent surgical treatment with advancement sleeve flaps or others that were not drainage and / or seton placement.
    -Any other condition that in the opinion of the investigator prevents the patient from completing the study.
    -Any other condition that reduces the life expectancy to less than 1 year, including knowledge of cancer.
    -Patients who do not accept their participation in the study and / or do not sign the informed consent document.
    -Pacientes con EPA no asociada a EII.
    -Pacientes con reacciones alérgicas moderadas o graves por anti-TNF.
    -EPA con más de dos orificios internos o tres orificios externos.
    -Fístulas rectovaginales.
    -Proctitis moderada o grave.
    -Estenosis anal o rectal que impida la realización de una ecoendoscopia.
    -Pacientes con más de dos trayectos fistulosos.
    -Pacientes con abscesos perianales no drenados de más de 2 cm.
    -PDAI < 4.
    -Pacientes que estén recibiendo tratamientos específicos locales de la enfermedad perianal como inyección de células madres. Ha de haber transcurrido más de un año desde que el paciente fue tratado con células madre para ser incluido en este estudio.
    -Portador de ileostomía definitiva.
    -Embarazo o lactancia, o deseo del mismo el próximo año.
    -Tratamiento quirúrgico reciente con colgajos de avance u otros que no fueran drenaje y o colocación de sedales.
    -Cualquier otra condición que en opinión del investigador le impida cumplir o completar el estudio.
    -Cualquier otra condición que disminuya su esperanza de vida a menos de 1 año, incluyendo el conocimiento de cáncer.
    -Pacientes que no acepten su participación en el estudio y/o no firmen el documento de consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoints are those related to the clinical activity of the PD (PDAI, including whether it drains spontaneously or at gentle pressure) and the morphological description of the PD (collections and trajectory: its presence, inflammatory signs and its size / length, both resonance as by endoanal ultrasound). Combined remission in week 24 (clinical and radiological) is considered to be the clinical observation of the closure of all external orifices that drained at baseline and the absence of collections greater than 2 cm in treated fistulous tracts confirmed by magnetic resonance.
    Las variables principales son las relativas a la actividad clínica de la EPA (PDAI, incluyendo si drena espontánemanete o a la presión suve) y la descripción morfológica de la EPA (colecciones y trayecto: su presencia, signos inflamatorios y su tamaño/longitud, tanto por resonancia como por ecografía endoanal). Se considera remisión combinada en la semana 24 (clínica y radiológica) la observación clínica del cierre de todos los orificios externos que drenaban en el momento basal y la ausencia de colecciones mayores de 2 cm en los trayectos fistulosos tratados confirmada por resonancia magnética.
    E.5.1.1Timepoint(s) of evaluation of this end point
    In all the visits: screening, week 4, 8, 12, 16, 20, and 24 the primary endpoints related to the PD will be evaluated: type of fistula (Parks classification) and its collection existence (yes or no).
    At the screening visit and week 24 (final visit) the radiological assessment of the PD will be carried out.
    En todas las visitas: screening, semana 4, 8, 12, 16, 20, y 24 se evaluarán las variables relativas a la EPA: tipo de fístula (clasificación de Parks) y su existencia de colección (si o no).
    En visita de screening y semana 24 (visital final) se realizará la valoración radiológica de la EPA.
    E.5.2Secondary end point(s)
    Personal and diagnostic history, clinical assesment, current treatment, inflammatory activity assesment.
    Variables de antecedentes personales y de diagnóstico, variables clínicas, tratamiento actual, variables relativas a la actividad inflamatoria
    E.5.2.1Timepoint(s) of evaluation of this end point
    Personal and diagnostic history, clinical assesment: at screening visit.
    Current treatment, inflammatory activity assesment: in all visits (screening, week 4, 8, 12, 16, 20 and 24).
    Variables de antecedentes personales y de diagnóstico: en visita de screening
    Variables clínicas, tratamiento actual variables relativas a la actividad inflamatoria: en todas las visitas (screening, semana 4, 8, 12, 16, 20 y 24).
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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.8.3 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.8.5The 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
    El final del estudio será la última visita del último sujeto
    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 months
    E.8.9.1In the Member State concerned days
    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: 10
    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 Yes
    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 Yes
    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 state10
    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 Decision2019-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-08-29
    P. End of Trial
    P.End of Trial StatusOngoing
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