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    Summary
    EudraCT Number:2018-002925-47
    Sponsor's Protocol Code Number:GIS-2018-BioIBD
    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:2018-11-16
    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 number2018-002925-47
    A.3Full title of the trial
    Identification of predictive biomarkers for response to biologic therapies in inflammatory bowel disease by proteomic and mass cytometry approaches
    IDENTIFICACIÓN DE BIOMARCADORES DE RESPUESTA AL TRATAMIENTO CON FÁRMACOS BIOLÓGICOS EN LA ENFERMEDAD INFLAMATORIA INTESTINAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    prediction of response to therapy in inflammatory bowel disease
    Predicción de respuesta al tratamiento en la enfermedad inflamatoria intestinal
    A.4.1Sponsor's protocol code numberGIS-2018-BioIBD
    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 SponsorFundación de Investigación Biomédica del Hospital Universitario de La Princesa
    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 supportInstituto de Salud Carlos III
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationfundación de Investigación Biomédica Hospital Universitario de La Princesa
    B.5.2Functional name of contact pointAna Garre
    B.5.3 Address:
    B.5.3.1Street AddressC/ Diego de León, 62, 3ª planta
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28006
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913093911
    B.5.5Fax number+34915204013
    B.5.6E-mailanagarre.laprincesa@gmail.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.2.1.1.1Trade name Adalimumab
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNADALIMUMAB
    D.3.9.1CAS number 331731-18-1
    D.3.9.4EV Substance CodeSUB20016
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 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.IMP: 2
    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 Infliximab
    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 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 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/kg milligram(s)/kilogram
    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 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 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.IMP: 3
    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 Golimumab
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGOLIMUMAB
    D.3.9.1CAS number 476181-74-5
    D.3.9.4EV Substance CodeSUB25638
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 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.IMP: 4
    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 Ustekinumab
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNUSTEKINUMAB
    D.3.9.1CAS number 815610-63-0
    D.3.9.3Other descriptive nameUSTEKINUMAB
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 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.IMP: 5
    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 Vedolizumab
    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 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.3.9.3Other descriptive nameVEDOLIZUMAB
    D.3.9.4EV Substance CodeSUB30452
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number300
    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 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
    Inflammatory bowel disease
    Enfermedad inflamatoria intestinal
    E.1.1.1Medical condition in easily understood language
    Corhn´s disease and ulcerative colitis
    Enfermedad de Crohn y colitis ulcerosa
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    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
    identify novel biomarkers of clinical response to the different available therapies in IBD, including Crohn´s disease (CD) and ulcerative colitis (UC).
    Identificar biomarcadores en sangre y en tejido intestinal mediante un abordaje de citometría de masas y proteómica que permitan predecir la respuesta a cada uno de los tratamientos biológicos aprobados actualmente (anti-TNFα, vedolizumab y ustekinumab) en pacientes con EII.
    E.2.2Secondary objectives of the trial
    1. To determine the presence and severity of endoscopic inflammation by non-invasive approaches (in the absence of a ilecolonoscopy), before starting treatment and on the follow-up period, with the aim of monitoring treatment response.
    2. To identify the immune cell subsets and signalling pathways specifically modulated by each of the biologic treatments in responding patients, both in CD and UC.
    3. To identify similarities and differences on the mechanism of action of a given drug in both UC and CD.
    1. -Estimar la presencia y gravedad de las lesiones endoscópicas de los pacientes con EII de manera no invasiva (esto es, sin precisar endoscopia); tanto al inicio del tratamiento biológico como tras haberlo recibido (en este último caso con el objetivo de monitorizar la respuesta al tratamiento).
    2. -Identificar las sub-poblaciones celulares del sistema inmune específicamente moduladas por cada uno de los distintos fármacos biológicos en los pacientes respondedores, tanto con enfermedad de Crohn (EC) como con colitis ulcerosa (CU).
    3.-Identificar similitudes y diferencias en el mecanismo de actuación (a nivel proteómico y celular) de un mismo tratamiento biológico en pacientes con EC y CU.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Group 1: Patients with IBD

    - Over 18 years.
    - Diagnosis of IBD according to the criteria of the European Crohns and Colitis Organization (ECCO).
    - Have indication of treatment with a biologic drug.
    - Be the first received biologic drug with a given mechanism of action (anti-TNFα, anti-α4β7 or anti-p40).
    - Have endoscopic activity of IBD within 1 month of starting the biologic treatment (see definitions section: SES-CD ≥ 3 in CD and endoscopic sub-index of May ≥ 2 in UC).
    - In the case of CD, receive the biologic treatment by luminal activity (not perianal).
    - Previous treatments (including corticosteroids and immunosuppressants) are allowed provided that they have been stable for the last 3 months prior to beginning treatment with biologics and that they are maintained at a stable dose for the duration of the study.

    Group 2: patients without IBD

    - Patients not diagnosed with IBD, or other inflammatory, allergic, malignant or autoimmune diseases, where a ilecolonoscopy is performed due to the normal clinical practice.
    GRUPO 1: PACIENTES CON EII

    - Mayores de 18 años.
    - Diagnóstico de EII según los criterios de la European Crohn´s and Colitis Organisation (ECCO).
    - Tener indicación de tratamiento con un fármaco biológico.
    - Ser el primer fármaco biológico que recibe con un determinado mecanismo de acción (anti-TNFα, anti-α4β7 o anti-p40).
    - Tener actividad endoscópica de la EII en el momento (o como máximo 1 mes antes) de iniciar el tratamiento biológico (véase apartado de definiciones: SES-CD ≥ 3 en EC y subíndice endoscópico de Mayo ≥ 2 en CU).
    - En el caso de la EC, recibir el tratamiento biológico por actividad luminal (no perianal).
    - Se permiten los tratamientos previos (incluyendo corticoides e inmunosupresores) siempre que se hayan mantenido estables durante los últimos 3 meses previo a iniciar el tratamiento con biológicos y que se mantengan a su vez a dosis estable durante la duración del estudio.

    GRUPO 2: PACIENTES SIN EII

    - Personas no diagnosticadas de EII, ni de otras enfermedades inflamatorias, alérgicas, malignas o autoinmunes que se realicen, por indicación médica, una colonoscopia, y que ésta sea normal.
    E.4Principal exclusion criteria
    Group 1: Patients with IBD

    - Under 18 years old.
    - Having an immune-mediated disease other than IBD at the baseline visit.
    - Having a neoplasm or an active infection at the time of the baseline visit.
    - Pregnancy or lactation.
    - Alcohol or drug abuse.
    - Ostomy.
    - Abdominal surgery in the last 6 months.
    - Colectomy in patients with UC.
    - Active infection with hepatitis B, C or HIV virus.
    - Indication of biologic treatment for a cause other than IBD.
    - Indication of biologic treatment to prevent postoperative recurrence in CD.
    - Have previously received a biologic drug with the same mechanism of action of the drug indicated by your doctor (anti-TNFα, anti-α4β7 or anti-p40).
    - Refusal to give consent for participation in the study.

    Group 2: patients without IBD

    - Under 18 years old.
    - Advanced chronic disease or any other pathology that prevents the follow-up of the protocol of this study.
    - Pregnancy or lactation.
    - Active infection with hepatitis B, C or HIV virus.
    - Alcohol or drug abuse.
    - Finding of macroscopic alterations during the ilecolonoscopy, or finding of relevant inflammatory alterations in the biopsies obtained during the ilecolonoscopy.
    - Treatment with immunomodulators, immunosuppressants, corticosteroids or other drugs that alter the immune system.
    - Refusal to give consent for participation in the study.
    GRUPO 1: PACIENTES CON EII

    - Menores de 18 años.
    - Padecer una enfermedad inmunomediada distinta de la EII en la visita basal.
    - Padecer una neoplasia o una infección activa en el momento de la visita basal.
    - Embarazo o lactancia.
    - Abuso de alcohol o drogas.
    - Ostomía.
    - Cirugía abdominal en los últimos 6 meses.
    - Colectomía en los pacientes con CU.
    - Infección activa por virus de la hepatitis B, C o VIH.
    - Indicación del tratamiento biológico por otra causa distinta de la EII.
    - Indicación del tratamiento biológico para prevenir la recurrencia postquirúrgica en la EC.
    - Haber recibido previamente un fármaco biológico con el mismo mecanismo de acción del fármaco indicado por su médico (anti-TNFα, anti-α4β7 o anti-p40).
    - Negativa a dar el consentimiento para la participación en el estudio.

    GRUPO 2: PACIENTES SIN EII

    - Menores de 18 años.
    - Enfermedad crónica avanzada o cualquier otra patología que impida el seguimiento del protocolo de este estudio.
    - Embarazo o lactancia.
    - Infección activa por virus de la hepatitis B, C o VIH.
    - Abuso de alcohol o drogas.
    - Hallazgo de alteraciones macroscópicas durante la realización de la colonoscopia, o hallazgo de alteraciones inflamatorias relevantes en las biopsias obtenidas durante la colonoscopia.
    - Tratamiento con inmunomoduladores, inmunosupresores, corticoides u otros fármacos que alteren el sistema inmune.
    - Negativa a dar el consentimiento para la participación en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Endoscopic response (main endpoint):

    - In patients with CD, the endoscopic response will be defined as a >50% decrease in the SES-CD [78] 14 weeks after starting the biologic treatment. As a secondary variable, endoscopic response will be also defined as a decrease ≥3 points in the SES-CD (considered as a clinically significant endoscopic improvement) [80]. There is consensus that the evaluation of the response to treatment (and therefore the consideration of a patient as a primary non-responder) should not be performed before week 12-14 (in patients treated with anti-TNFα drugs) [13, 19, 81].
    - In patients with UC, the endoscopic response will be defined as a decrease of ≥1 point in the Mayo endoscopic sub-score [82] 14 weeks after starting the biologic treatment.
    Respuesta endoscópica (variable principal de valoración):

    - En los pacientes con EC, la respuesta endoscópica se definirá como una disminución >50% en el SES-CD(78) 14 semanas después de haber iniciado el tratamiento biológico. Se evaluará también como variable secundaria la respuesta endoscópica definida como una diminución ≥3 puntos en el SES-CD (considerado como una mejoría endoscópica clínicamente significativa)(80) en la semana 14. Existe consenso en que la evaluación de la respuesta al tratamiento (y por tanto la consideración de un paciente como no respondedor primario) no debe realizarse antes de la semana 12-14 (en los pacientes tratados con fármacos anti-TNFα)(13, 19, 81).
    - En los pacientes con CU, la respuesta endoscópica se definirá como una disminución ≥1 punto en el subíndice endoscópico del índice de Mayo(82) 14 semanas después de haber iniciado el tratamiento biológico.
    E.5.1.1Timepoint(s) of evaluation of this end point
    14 weeks
    14 semanas
    E.5.2Secondary end point(s)
    Endoscopic activity:

    - In patients with CD, it will be evaluated using the Simplified Endoscopic Activity Score for Crohn's Disease [64, 76-78] (SES-CD); Endoscopic activity will be considered when the SES-CD is ≥3. In operated patients, or in those where the endoscopic exploration is incomplete, the SES-CD will be calculated according to the explorable segments, considering the previously described activity criterion.
    - In patients with UC, it will be evaluated by the Mayo endoscopic sub-score [61, 79]; endoscopic activity will be considered as ≥2.
    - The assessment of endoscopic activity will be carried out centrally by sending anonymized endoscopic images.

    Endoscopic remission:

    - In patients with CD, endoscopic remission will be defined as a SES-CD ≤2, 14 weeks after starting the biologic treatment.
    - In patients with UC, endoscopic remission will be defined as an endoscopic subscript ≤1, 14 weeks after starting the biologic treatment.

    Clinical activity:

    - In patients with CD, it will be evaluated using the Crohn's Disease Activity Index (CDAI) [83]. Clinical remission will be considered as a CDAI <150 points 14 weeks after starting the biologic treatment; and clinical response, reduction of CDAI by 100 (R-100) or 70 points (R-70) [83].
    - In patients with UC it will be evaluated by the partial Mayo index [83]. Clinical remission will be considered as a partial Mayo index ≤2, with all the scores (of the partial index) of 1 as a maximum and with a sub-score of rectal bleeding of 0, 14 weeks after starting the biologic treatment [83]; and clinical response, the decrease of 3 or more points (of the partial index) with respect to the baseline situation [84].
    Actividad endoscópica:

    - En los pacientes con EC se evaluará mediante el Simplified Endoscopic Activity Score for Crohn’s Disease(64, 76-78) (SES-CD); se considerará que existe actividad endoscópica cuando el SES-CD sea ≥3. En pacientes operados, o en aquellos donde la exploración endoscópica sea incompleta, el SES-CD se calculará atendiendo a los segmentos explorables, considerándose el criterio de actividad previamente descrito.
    - En los pacientes con CU se evaluará mediante el subíndice endoscópico del índice de Mayo(61, 79); se considerará actividad endoscópica un subíndice endoscópico ≥2.
    - La valoración de la actividad endoscópica se realizará de forma centralizada mediante el envío de imágenes endoscópicas anonimizadas.

    Remisión endoscópica:

    - En los pacientes con EC, la remisión endoscópica se definirá como un SES-CD ≤2, 14 semanas después de haber iniciado el tratamiento biológico.
    - En los pacientes con CU, la remisión endoscópica se definirá como un subíndice endoscópico ≤1, 14 semanas después de haber iniciado el tratamiento biológico.

    Actividad clínica:

    - En los pacientes con EC se evaluará mediante el Crohn's Disease Activity Index (CDAI)(83). Se considerará remisión clínica un CDAI <150 puntos en la EC, 14 semanas después de haber iniciado el tratamiento biológico; y respuesta clínica, la reducción del CDAI en 100 (R-100) o 70 puntos (R-70)(83).
    - En los pacientes con CU se evaluará mediante el índice de Mayo parcial(83). Se considerará remisión clínica un índice de Mayo parcial ≤2, con todas las puntuaciones (del índice parcial) de 1 como máximo y con una subpuntuación de rectorragia de 0, 14 semanas después de haber iniciado el tratamiento biológico(83); y respuesta clínica, el descenso de 3 o más puntos (del índice parcial) respecto a la situación basal(84).
    E.5.2.1Timepoint(s) of evaluation of this end point
    14 weeks
    14 semanas
    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 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 No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    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 trial6
    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 concerned19
    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 paciente
    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 months36
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 30
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state180
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 180
    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)
    traducir
    El tratamiento se asignará por práctica clínica y bajo el criterio del investigador de cada uno de los centros. Por lo tanto antes de iniciar el ensayo, como una vez finalizado será el médico responsable el que bajo su juicio clínico decida cual es la opción terapéutica más adecuada.
    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 Decision2018-12-28
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-26
    P. End of Trial
    P.End of Trial StatusOngoing
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