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    Summary
    EudraCT Number:2017-004496-31
    Sponsor's Protocol Code Number:CNTO148UCO3003
    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:2018-08-28
    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 number2017-004496-31
    A.3Full title of the trial
    A Phase 3 Randomized, Open-Label Study to Assess the Efficacy, Safety,
    and Pharmacokinetics of Golimumab Treatment, a Human anti-TNFα
    Monoclonal Antibody, Administered Subcutaneously in Pediatric
    Participants with Moderately to Severely Active Ulcerative Colitis
    Estudio fase 3 aleatorizado, abierto, para evaluar la Eficacia, Seguridad y Farmacocinética del tratamiento de Golimumab, un anticuerpo humano monoclonal anti-TNF#, administrado por vía subcutánea en pacientes pediátricos con Colitis Ulcerosa activa de moderada a severa.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of the Efficacy and Safety of Golimumab in Pediatric Participants
    with Moderately to Severely Active Ulcerative Colitis
    Un estudio sobre la eficacia y seguridad de Golimumab en pacientes pediátricos con Colitis Ulcerosa activa de moderada a severa.
    A.3.2Name or abbreviated title of the trial where available
    PURSUIT 2
    PURSUIT 2
    A.4.1Sponsor's protocol code numberCNTO148UCO3003
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/065/2018
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen Biologics BV
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag S.A
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.3.4CountrySpain
    B.5.4Telephone number+3491722 7964
    B.5.5Fax number+3491722 8628
    B.5.6E-mailvvillare@its.jnj.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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGolimumab
    D.3.2Product code CNTO148
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 number50
    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.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 No
    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 nameGolimumab
    D.3.2Product code CNTO148
    D.3.4Pharmaceutical form Solution for injection in pre-filled pen
    D.3.4.1Specific paediatric formulation Yes
    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 number45
    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.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 Simponi
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGolimumab
    D.3.2Product code CNTO148
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    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 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.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 Remicade
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen Biologics BV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameInfliximab
    D.3.4Pharmaceutical form Powder for concentrate and solution 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 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 typerange
    D.3.10.3Concentration number5 to 10
    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
    Ulcerative Colitis
    Colitis Ulcerosa
    E.1.1.1Medical condition in easily understood language
    Ulcerative Colitis
    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 100000004856
    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 of golimumab in inducing clinical remission as
    assessed by the Mayo score, in pediatric participants with moderately to
    severely active UC.
    •To evaluate the safety profile of golimumab, in pediatric participants
    with moderately to severely active UC.
    •Evaluar la eficacia del golimumab en la inducción de la remisión clínica en participantes menores de edad con colitis ulcerosa (CU) activa de moderada a grave, de acuerdo con la puntuación de la clínica Mayo • Evaluar el perfil de seguridad del golimumab en participantes menores de edad con CU activa de moderada a grave
    E.2.2Secondary objectives of the trial
    •To evaluate the efficacy of golimumab in inducing clinical response as
    assessed by the Mayo Score and clinical remission as measured by the
    PUCAI Score.
    •To evaluate the efficacy of golimumab on endoscopic healing.
    •To evaluate the efficacy of golimumab during the long-term phase.
    •To evaluate the effect of golimumab on additional efficacy and quality
    of life (QOL) measures
    •To evaluate the PK and exposure response of golimumab during shortand
    long-term phases.
    •Evaluar la eficacia del golimumab en la inducción de la respuesta (de acuerdo con la puntuación de la clínica Mayo) y la remisión clínicas (de acuerdo con la puntuación del índice de actividad de la colitis ulcerosa pediátrica [PUCAI]) • Evaluar la eficacia del golimumab desde el punto de vista de la cicatrización endoscópica • Evaluar la eficacia del golimumab durante la fase a largo plazo • Evaluar el efecto del golimumab de acuerdo con criterios adicionales de valoración de la eficacia y la calidad de vida • Evaluar la farmacocinética y la respuesta a la exposición al golimumab durante las fases a corto y largo plazo
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Usability Assessment Substudy (see appendix 18 of the CNTO148UCO3003 protocol). The Usability Assessment Substudy will be conducted at US sites only. The objective of the Substudy is to provide supportive data that the PFS as designed, together with the appropriate training and written Instructions for Use, is suitable for at home administration by pediatric participants or their caregivers.
    Subestudio para la evaluación de la utilizabilidad (ver apéndice 18 del protocolo CNTO148UCO3003) El Subestudio para la evaluación de la utilizabilidad será realizado en centros de Estados Unidos únicamente. El objetivo del subestudio es proporcionar datos que demuestren que la jeringa precargada tal y como ha sido diseñada, junto con el adecuado entrenamiento e instrucciones de uso descritas, es adecuada para la administración en casa por pacientes pediátricos o sus cuidadores.
    E.3Principal inclusion criteria
    1. Must be 2 to 17 years of age (at the time of the first administration of
    study intervention at Week 0) of either gender with a body weight ≥10
    kg and >70 cm height.
    2. Must have had UC diagnosed for at least 1 month prior to screening.
    3. Must have the diagnosis of UC confirmed by a prior endoscopic biopsy
    that is consistent with a diagnosis of UC (eg, crypt distortion, crypt
    abscess, goblet cell depletion, and continuous distribution).
    4. Must have moderately to severely active UC (as defined by baseline
    Mayo score of 6 through 12 [endoscopy {sigmoidoscopy or colonoscopy}
    subscore assigned by local endoscopist], inclusive).
    5. Must have a Mayo endoscopy (sigmoidoscopy or colonoscopy)
    subscore ≥2 (subscore assigned by local endoscopist) at baselineendoscopy (indicative of moderately to severely active UC). Baseline
    endoscopy (sigmoidoscopy or colonoscopy) must be performed with
    study software and occur no more than 2 weeks before first study
    intervention administration.
    6. Prior or current medication for UC must include at least 1 of the following (Appendix 2
    [Section 10.2]):
    a. Current treatment with at least 1 of the following therapies: oral or intravenous
    corticosteroids, or the immunomodulators 6-MP, MTX, or AZA.
    OR
    b. Have a history of failure to respond to or tolerate, or have a medical
    contraindication to, at least 1 of the following therapies: oral or intravenous
    corticosteroids or the immunomodulators 6-MP, MTX, or AZA.
    OR
    c. Currently have or have had a history of corticosteroid dependency (ie, an
    inability to successfully taper corticosteroids without a return of the symptoms
    of UC).
    OR
    d. Have required more than 3 courses of oral or intravenous corticosteroids in the
    past year.
    7. Must meet concomitant medication stability criteria prior to the first
    administration of study intervention.
    8. If receiving parenteral or enteral nutrition, must have been on a
    stable regimen for at least 2 weeks prior to the first administration of
    study intervention at Week 0.
    9. Must have discontinued the use of antibiotics for the treatment of UC
    (eg, ciprofloxacin, metronidazole, or rifaximin) for at least 1 week prior
    to screening.
    10. Must have discontinued the use of 6-thioguanine (6-TG) for at least 4
    weeks prior to screening.
    11. If at increased risk for colon cancer, must either have had a
    colonoscopy to assess the presence of dysplasia within 1 year prior to
    the first administration of study intervention at Week 0 or a colonoscopy
    to assess the presence of malignancy as the baseline endoscopy.
    Baseline endoscopy (sigmoidoscopy or colonoscopy) must be performed
    with study software and occur no more than 2 weeks before first study
    intervention administration.
    12. Before randomization, a girl must be either:
    a. Not of childbearing potential defined as:
    1) Premenarchal
    2) Permanently sterile
    b. Of childbearing potential and
    1) Practicing a highly effective method of contraception (failure rate of
    <1% per year when used consistently and correctly) during the study
    and for 6 months after receiving the last dose of study intervention. Both
    user-independent and user-dependent methods of contraception are
    allowed.
    13. Boys must agree not to donate sperm for the purpose of reproduction
    during the study and for a minimum 6 months after receiving the last
    dose of study intervention.
    14. All girls of childbearing potential must have a negative serum
    pregnancy test at screening.
    15. A girl of childbearing potential must have a negative urine pregnancy
    test prior to study intervention administration at Week 0.
    16. Girls of childbearing age must agree not to donate eggs (ova,
    oocytes) for the purposes of assisted reproduction during the study and
    for a minimum 6 months after receiving the last dose of study
    intervention.
    17. Are considered eligible according to the following TB screening
    criteria:
    •Have no history of latent or active TB prior to screening.
    •Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    •Have had no recent close contact with a person with active TB.
    •During the screening period have a negative QuantiFERON®-TB test
    result. Within 1 month, prior to the first study intervention
    administration a negative tuberculin skin test is additionally required if
    the QuantiFERON®-TB test is not approved/registered in that country or
    the tuberculin skin test (Appendix 3 [Section 10.3]) is mandated by local
    health authorities.
    •Indeterminate results should be handled as outlined in Section 8.3.6.
    For more information on inclusion criteria see section 5.1 of the protocol.
    1.Pacientes entre 2 y 17 años de edad (en el momento de la primera administración del estudio, en semana 0) cualquier sexo, peso corporal ≥10 kg y >70 cm de altura. 2. Debe tener Colitis Ulcerosa (CU)diagnosticada desde al menos 1 mes antes de la visita de screening.3. Debe tener diagnosticada CU confirmada por una biopsia endoscópica previa que sea consistente con una diagnosis de CU (ej., distorsión de la cripta, absceso de la cripta, depleción de células caliciformes y distribución continua) 4.Debe tener CU de moderada a severa (definida por la puntuación de la clínica Mayo de 6 sobre 12 – (subpuntuación asignada a la endoscopia -sigmoidoscopia o colonoscopia- por el endoscopista local, incluida)5. Debe tener una endoscopia (sigmoidoscopia o colonoscopia) con una subpuntuación de la clínica Mayo ≥2 (subpuntuación asignada por el endoscopista local) en la endoscopia basal (indicativa de una CU de moderada a severa). La endoscopia (sigmoidoscopia o colonoscopia) basal debe realizarse con el software del estudio y no antes de 2 semanas previas a la primera administración del estudio.6. Medicación previa o actual para la CU debe incluir al menos 1 de las siguientes (Apéndice 2, Sección 10.2): a.Tratamiento actual con al menos 1 de las siguientes terapias: corticosteroides orales o intravenosos, o inmunomoduladores 6-MP, MTX o AZA, Ó b.Tener una historia de fallo de respuesta o tolerancia, o tener una contraindicación médica de, al menos 1 de las siguientes terapias: corticosteroides orales o intravenosos, o inmunomoduladores 6-MP, MTX o AZA, Ó c.Tener actualmente o haber tenido una historia de dependencia a los corticosteroides (ej., una incapacidad de disminuir los corticosteroides sin que recurran los síntomas de CU), Ó d.Haber necesitado más de 3 ciclos de corticosteroides orales o intravenosos durante el pasado año.7. Debe cumplir con los criterios de estabilidad de medicación concomitante antes de la primera administración del estudio.8. Si recibe nutrición parenteral o enteral, debe haber estado en un régimen estable durante al menos 2 semanas antes de la primera administración del estudio en la semana 0. 9. Debe haber interrumpido el uso de antibióticos para el tratamiento de CU (p. Ej., Ciprofloxacin, metronidazol o rifaximina) durante al menos 1 semana antes del Screening. 10. Debe haber interrumpido el uso de 6-tioguanina (6-TG) durante al menos 4 semanas antes del Screening. 11. Si hay un mayor riesgo de cáncer de colon, se debe haber realizado una colonoscopia para evaluar la presencia de displasia 1 año antes de la primera administración del estudio en la semana 0, o una colonoscopia para evaluar la presencia de malignidades en la endoscopia inicial. La endoscopia basal (sigmoidoscopia o colonoscopia) debe de hacerse a través del software del estudio y debe realizarse no más de 2 semanas antes de la primera administración del estudio. 12. Antes de la aleatorización, las niñas deben ser: a. No fértiles, definido como:1) Premenárquica. 2) Permanentemente estéril. b. Potencialmente fértiles y 1) Practicar un método anticonceptivo altamente eficaz (índice de fracaso de <1% por año cuando se usa de manera consistente y correcta) durante el estudio y durante los 6 meses después de recibir la última dosis del estudio.Se permiten tanto los métodos anticonceptivos independientes como los dependientes del usuario.13. Los niños varones deben aceptar no donar esperma con propósito reproductivo durante el estudio y durante un mínimo de 6 meses después de recibir la última dosis del estudio.14. Todas las niñas en edad fértil deben tener una prueba de embarazo en suero negativa en la visita de selección.15. Una niña en edad fértil debe tener una prueba de embarazo de orina negativa antes de la administración de fármaco del estudio en la semana 0. 16. Las niñas en edad fértil deben aceptar no donar óvulos (óvulos, ovocitos) para fines de reproducción asistida durante el estudio y durante un mínimo de 6 meses después de recibir la última dosis de la intervención del estudio.17. Se consideran elegibles de acuerdo con los siguientes criterios de TB durante la selección: • No tener antecedentes de tuberculosis latente o activa antes de la selección. • No presentar signos o síntomas que sugieran una TB activa en el historial médico y / o el examen físico. • No haber tenido un contacto cercano reciente con una persona con TB activa. • Durante el período de selección, obtener un resultado de prueba de QuantiFERON®-TB negativo. En el mes previo a la primera administración del estudio, se requiere adicionalmente una prueba cutánea de tuberculina negativa si el examen QuantiFERON®-TB no está aprobado/registrado en ese país o la prueba cutánea de tuberculina (Apéndice 3 [Sección 10.3]) es obligatoria según las autoridades locales de salud. • Los resultados indeterminados deben manejarse como se describe en la Sección 8.3.6. Para más información sobre los criterios de inclusión, consulte sección 5.1 del protocolo.
    E.4Principal exclusion criteria
    1. Have severe, extensive colitis as evidenced by:
    a. Investigator judgment that the participant is likely to require a
    colectomy within 12 weeks of Week 0.
    OR
    b. Symptom complex at screening or Week 0 visit that includes at least 4
    of the following:
    1) Diarrhea with ≥6 bowel movements/day with macroscopic blood in
    stool
    2) Focal severe or rebound abdominal tenderness
    3) Persistent fever (≥37.5°C) for more than 5 days
    4) Persistent tachycardia for more than 5 days
    5) Anemia (hemoglobin < 8.5 g/dL)
    2. Participants with very severe active UC disease who are currently
    hospitalized for UC disease exacerbation when initiating study screening
    and who have a Mayo score of 12 should be excluded from the study.
    3. History of liver or renal insufficiency; significant cardiac, vascular,
    pulmonary, gastrointestinal, endocrine, neurologic, hematologic,
    rheumatologic, psychiatric (including suicidality), or metabolic
    disturbances.
    4. History of malignancy or macrophage activation syndrome (MAS) or
    hemophagocytic lymphohistiocytosis (HLH).
    5. A serious allergic reaction to latex.
    6. Contraindications to the use of golimumab or infliximab or anti-TNFα
    therapy per local prescribing information.
    7. Taken any disallowed therapies as noted in Section 6.5, Concomitant
    Therapy before the planned first dose of study intervention.
    8. Received an investigational vaccine or used an invasive investigational
    medical device within 3 months before the planned first dose of study
    intervention or is currently enrolled in an investigational study.
    9. Pregnant, or breast-feeding, or planning to become pregnant while
    enrolled in this study or within 6 months after the last dose of study
    intervention.
    10. Plans to father a child while enrolled in this study or within 6 months
    after the last dose of study intervention.
    11. Any condition for which, in the opinion of the investigator,
    participation would not be in the best interest of the participant (eg,
    compromise the well-being) or that could prevent, limit, or confound the
    protocol-specified assessments
    12. Had major surgery, (eg, requiring general anesthesia) within 3 months before screening, or will not have fully recovered from surgery,
    or has surgery planned during the time the participant is expected to
    participate in the study or within 3 months after the last dose of study
    intervention administration.
    13. Have UC limited to the rectum only or to <20% of the colon.
    14. Presence of a stoma.
    15. Presence or history of a fistula.
    16. Have severe, fixed symptomatic stenosis of the large or small
    intestine.
    17. Require, or required within the 2 months prior to screening, surgery
    for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or
    intra-abdominal or pancreatic abscess requiring surgical drainage, or
    other conditions possibly confounding the evaluation of benefit from
    study intervention treatment.
    18. Presence or history of colonic or small bowel obstruction within 6
    months prior to screening, confirmed by objective radiographic or
    endoscopic evidence of a stricture with resulting obstruction (dilation of
    the colon or small bowel proximal to the stricture on barium radiograph
    or an inability to traverse the stricture at endoscopy).
    19. History of extensive colonic resection (eg, less than 30 cm of colon
    remaining) that would prevent adequate evaluation of the effect of study
    intervention on clinical disease activity.
    20. Presence on screening endoscopy of adenomatous colonic polyps, if
    not removed prior to study entry, or history of adenomatous colonic
    polyps that were not removed.
    21. Have evidence of Crohn's disease:
    a. Small intestinal or ileal disease by upper gastrointestinal small bowel
    follow-through, ileocolonoscopy with histology, videocapsule endoscopy,
    or Magnetic Resonance Enterography (MRE)
    b. Noncaseating and non-mucin granulomas that are suggestive of a
    diagnosis of Crohn's disease on colonoscopy
    c. Skip lesions on colonoscopy including absolute rectal sparing, with a
    normal rectum both endoscopically and histologically
    d. Perianal disease
    22. Have received any anti-TNFα biologic agents (eg, monoclonal
    antibody therapies).
    23. Has received other agents intended to suppress or eliminate TNFα <8
    weeks prior to first administration of study intervention.
    24. Have received natalizumab within 12 months of first study
    intervention administration.
    25. Have received agents that deplete B or T cells (eg, rituximab,
    alemtuzumab, or visilizumab) within 12 months of first study
    intervention administration, or continue to manifest depletion of B or T
    cells more than 12 months after completion of therapy with lymphocyte
    depleting agents.
    For more information on Exclusion Criteria see section 5.2 of the
    protocol.
    1.Tener colitis severa y extensa como se evidencia por:a. A juicio del investigador es probable que el participante requiera una colectomía dentro de las 12 semanas de la semana 0. O b. Síntomas complejos en la visita de selección o en la visita de la Semana 0 que incluye al menos 4 de los siguientes:1) Diarrea con #6 deposiciones/día con sangre macroscópica en las deposiciones2)Sensibilidad focal abdominal severa3) Fiebre persistente (#37.5 ° C) durante más de 5 días 4)Taquicardia persistente por más de 5 días5) Anemia (hemoglobina <8.5 g / dL) 2. Los participantes con colitis ulcerosa (CU) activa muy grave que actualmente están hospitalizados por exacerbación de la enfermedad cuando se realiza la selección del estudio y que tienen una puntuación del Índice Mayo score de 12 deben ser excluidos del estudio.3. Historial de insuficiencia hepática o renal; importantes alteraciones cardíacas, vasculares, pulmonares, gastrointestinales, endocrinas, neurológicas, hematológicas, reumatológicas, psiquiátricas (incluida la ideación suicida) o alteraciones metabólicas.4. Historia de malignidad o síndrome de activación de macrófagos (MAS) o HLH.5. Una reacción alérgica grave al látex.6.Contraindicaciones para el uso de golimumab o infliximab o terapia anti-TNF# según la información de prescripción local.7.Tomar terapias no permitidas como se indica en la Sección 6.5,Terapia concomitante antes de la primera dosis planificada del estudio.8.Si recibió una vacuna en investigación o utilizó un dispositivo médico invasivo en investigación dentro de los 3 meses anteriores a la primera dosis planificada del estudio o actualmente está participando en un estudio de investigación.9.Estar embarazada, o amamantando, o planeando quedarse embarazada mientras está participando en este estudio o dentro de los 6 meses posteriores a la última dosis del estudio.10.Si es hombre,planear engendrar un hijo mientras está participando en este estudio o dentro de los 6 meses posteriores a la última dosis del estudio.11.Cualquier condición para la cual, en opinión del investigador, la participación no redundaría en el mejor interés del participante (p. Ej., Comprometería el bienestar) o que podría prevenir, limitar o confundir las evaluaciones especificadas por el protocolo.12.Cirugía mayor (p. Ej., que requirió anestesia general) dentro de los 3 meses anteriores a la selección, o no se haberse recuperado completamente de la cirugía, o tener programada una cirugía durante la participación del paciente en el estudio o dentro de los 3 meses tras la administración de la última dosis del estudio.13.CU limitada al recto solamente o a <20% del colon.14.Estoma.15.Presencia o historia de fístula.16. Estenosis sintomática grave y fija del intestino grueso o delgado.17.Requerir dentro de los 2 meses previos a la selección, cirugía para un sangrado gastrointestinal activo, peritonitis, obstrucción intestinal o absceso intraabdominal o pancreático que requiera drenaje quirúrgico u otras afecciones que puedan confundir la evaluación del beneficio del tratamiento del estudio. 18. Presencia o antecedentes de obstrucción colónica o del intestino delgado dentro de los 6 meses anteriores a la selección, confirmada por evidencia objetiva radiográfica o endoscópica de una estenosis resultante en obstrucción (dilatación del colon o del intestino delgado proximal en la radiografía de bario o incapacidad de atravesar la estenosis en la endoscopia).19.Antecedentes de resección colónica extensa (p. Ej., Menos de 30 cm del colon restante) que evitarían una evaluación adecuada del efecto del tratamiento del estudio sobre la actividad clínica de la enfermedad.20.Presencia en la endoscopia de selección de pólipos colónicos adenomatosos, si no se los quitan antes del ingreso al estudio, o antecedentes de pólipos colónicos adenomatosos que no se eliminaron.21.Evidencia de enfermedad de Crohn(EC): a.Sindrome del intestino corto o afectación ileal por el intestino delgado superior, ileocolonoscopia con histología, endoscopia con videocápsula o enterografía por resonancia magnética (ERM) b. Granulomas no caseosos y no mucinosos que sugieren un diagnóstico de EC en la colonoscopia c.Omitir lesiones en la colonoscopia, incluida la preservación rectal absoluta, con un recto normal tanto endoscópico como histológico d. Enfermedad perianal22.Haber recibido agentes biológicos anti-TNF# (p. Ej.,Terapias con anticuerpos monoclonales).23.Haber recibido otros agentes destinados a suprimir o eliminar el TNF# <8 semanas antes de la primera administración del fármaco del estudio.24.Haber recibido natalizumab en los 12meses previos a la primera administración del fármaco del estudio.25.Haber recibido agentes que disminuyen las células B o T dentro de los 12 meses posteriores a la primera administración,o continuar manifestando la depleción de células B o T más de 12 meses después de la finalización de la terapia con agentes deplectores de linfocitos.Más información: sección 5.2 del protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical remission as assessed by the Mayo
    score.
    El criterio principal de valoración es la remisión clínica, de acuerdo con la puntuación de la clínica Mayo
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 6
    Semana 6
    E.5.2Secondary end point(s)
    1. Clinical response as assessed by the Mayo score (based on Mayo
    endoscopy subscore assigned by the local endoscopist).
    2. Clinical remission as assessed by the PUCAI score.
    3. Endoscopic healing (based on Mayo endoscopy subscore assigned by
    the local endoscopist).
    4. Clinical remission as assessed by the PUCAI score.
    5. Endoscopic healing (based on Mayo endoscopy subscore assigned by
    the local endoscopist).
    •Respuesta clínica en la semana 6, de acuerdo con la puntuación de la clínica Mayo (que a su vez se basará en la subpuntuación endoscópica de Mayo asignada por el endoscopista local). • Remisión clínica en la semana 6, de acuerdo con la puntuación PUCAI. • Cicatrización endoscópica en la semana 6 (de acuerdo con la subpuntuación endoscópica de Mayo asignada por el endoscopista local). • Remisión clínica en la semana 54, de acuerdo con la puntuación PUCAI. • Cicatrización endoscópica en la semana 54 (de acuerdo con la subpuntuación endoscópica de Mayo asignada por el endoscopista local).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 6
    2. Week 6
    3. Week 6
    4. Week 54
    5. Week 54
    1. Semana 6 2. Semana 6 3. Semana 6 4. Semana 54 5. 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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    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 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Brazil
    France
    Israel
    Italy
    Korea, Republic of
    Netherlands
    Poland
    Spain
    Taiwan
    United States
    E.8.7Trial has a data monitoring committee Yes
    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 years6
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days10
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days27
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Yes
    F.1.1Number of subjects for this age range: 125
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 37
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 88
    F.1.2Adults (18-64 years) No
    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 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 state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 55
    F.4.2.2In the whole clinical trial 125
    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)
    Beginning at Week 58, participants who are eligible to continue
    receiving golimumab in the study extension will be offered the option
    for self-administration (at least 12 years old and body weight ≥45 kg)
    or caregiver-administration (any age but body weight ≥45 kg). This is
    optional; if a pediatric participant or caregiver elects against self- or
    caregiver-administration, the health care professional will continue to
    administer injections in this study.
    Desde la semana 58, a los pacientes que son aptos para continuar con golimumab en la extensión del estudio, les será ofrecida la opción de auto-administración(#12 años de edad y peso corporal de #45 kg) o administración por parte del cuidador/a (cualquier edad pero peso #45 kg). Esto es opcional; si un paciente pediátrico o su cuidador elige no auto-administrarse o que le administre la medicación su cuidador, el profesional de la salud continuará administrándole las inyecciones en este estudio
    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 Decision2018-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-05
    P. End of Trial
    P.End of Trial StatusOngoing
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