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    Summary
    EudraCT Number:2011-004579-35
    Sponsor's Protocol Code Number:A3921095
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-03-09
    Trial results View 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 number2011-004579-35
    A.3Full title of the trial
    A MULTICENTRE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF ORAL CP-690,550 AS AN INDUCTION THERAPY IN SUBJECTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
    Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos de CP-690.550 por vía oral como tratamiento de inducción en pacientes con colitis ulcerosa entre moderada e intensa
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of oral CP-690,550 as an induction therapy in subjects with moderate to severe ulcerative colitis.
    Un estudio de CP-690,550 por vía oral como tratamiento de inducción en pacientes con colitis ulcerosa entre moderada e intensa
    A.4.1Sponsor's protocol code numberA3921095
    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 SponsorPfizer Inc, 235 East 42nd Street, New York, New York 10017
    B.1.3.4CountryUnited States
    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 supportPfizer Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPfizer Inc.
    B.5.2Functional name of contact pointClinical Trials.gov Call Center
    B.5.3 Address:
    B.5.3.1Street Address235 East 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number0018007181021
    B.5.5Fax number001303739 1119
    B.5.6E-mailclinicaltrials.govcallcenter@pfizer.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 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 nameCP-690,550-10
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nametofacitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderate to severe active Ulcerative Colitis
    Colitis Ulcerosa de moderada a severa
    E.1.1.1Medical condition in easily understood language
    Moderate to severe active Ulcerative Colitis
    Colitis Ulcerosa de Moderada a Severa.
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10045365
    E.1.2Term Ulcerative colitis
    E.1.2System Organ Class 10017947 - Gastrointestinal disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To demonstrate the efficacy of CP-690,550 in inducing remission in subjects with moderately to severely active ulcerative colitis.
    Demostrar la eficacia de CP-690.550 en cuanto a la inducción de la remisión en
    pacientes con colitis ulcerosa con actividad entre moderada e intensa
    E.2.2Secondary objectives of the trial
    ? To evaluate the safety and tolerability of CP-690,550 in subjects with moderately to
    severely active ulcerative colitis.
    ? To evaluate the efficacy of CP-690,550 in achieving mucosal healing in subjects with moderately to severely active ulcerative colitis.
    ? To evaluate the effect of CP-690,550 induction therapy on clinical outcomes in subjects
    with moderately to severely active ulcerative colitis.
    ? To evaluate the CP-690,550 pharmacokinetic (PK) exposure during induction therapy in subjects with moderately to severely active ulcerative colitis.
    ? To evaluate the effect of induction treatment of CP-690,550 on quality-of-life in subjects with moderately to severely active ulcerative colitis.
    Evaluar la seguridad y la tolerabilidad de CP-690.550 en pacientes con colitis ulcerosa con actividad entre moderada e intensa. ? Evaluar la eficacia deCP-690.550 en cuanto a la consecución de la cicatrización de la mucosa en pacientes con colitis ulcerosa con actividad entre moderada e intensa Evaluar el efecto del tratamiento de inducción con CP-690.550 sobre variables clínicas en pacientes con colitis ulcerosa con actividad entre moderada e intensa. ? Evaluar la exposición farmacocinética (FC) a CP-690.550 durante el tratamiento de inducción en pacientes con colitis ulcerosa con actividad entre moderada e intensa. ? Evaluar el efecto del tratamiento de inducción con CP-690.550 sobre la calidad de vida en pacientes con colitis ulcerosa con actividad entre moderada e intensa.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Subject must be at least 18 years of age.
    2. Males and females with a documented diagnosis (endoscopic or radiographic and histological) of UC ?4 months prior to entry into the study. A biopsy report supporting the diagnosis must be available in the source documents.
    3. Subjects with moderately to severely active UC as defined by a total Mayo score of ?6, with a rectal bleeding score of ?1 and an endoscopic subscore of ?2 on the Mayo score determined within 7 days of baseline visit (Visit 2).
    4. Subjects must have failed or be intolerant (discontinued the medication due to an adverse event as determined by the investigator) of at least one of the following treatments for UC:
    ? Oral corticosteroids.
    ? Azathioprine or 6 mercaptopurine (6 MP).
    ? Anti TNF therapy: infliximab or adalimumab.
    5. Subjects currently receiving the following treatment for UC are eligible providing they have been and are anticipated to be on stable dose for designated period of time:
    ? Oral 5 ASA or sulfasalazine stable dose for at least 4 weeks prior to baseline and during the study period.
    ? Oral corticosteroids (prednisone equivalent up to 25 mg/day; budesonide up to 9 mg/day) stable dose for at least 2 weeks prior to baseline and during the study period.
    ? Chronic treatment for ulcerative colitis with antibiotics (eg, metronidazole, rifaximin) stable dose for at least 2 weeks prior to baseline and during the study period.
    6. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined by all of the following:
    ? A negative QuantiFERON® TB Gold (QFT G) In Tube test or, if unavailable or indeterminate upon retest, a Mantoux/Purified Protein Derivative (PPD) tuberculin skin test as per local medical standard of practice, with a result of <5 mm of induration, performed at or within the 3 months prior to a given Screening visit. [It is recommended that subjects with a history of Bacille Calmette Guérin (BCG) vaccination be tested with the QFT G test].
    ? A chest radiograph, taken at or within the 3 months prior to a given Screening visit, without changes suggestive of active TB infection as determined by a qualified radiologist.
    ? No history of either untreated or inadequately treated latent or active TB infection.
    ? If a subject has previously received an adequate course of therapy for either latent (9 months of isoniazid in a locale where rates of primary multi drug TB resistance are <5% or an acceptable alternative regimen) or active (acceptable multi drug regimen) TB infection, neither a QFT G test nor a PPD test is needed, but a chest radiograph must still be obtained if not performed within 3 months prior to a given Screening visit. Documentation of adequate treatment for TB will be obtained prior to first dose of study drug.
    ? A subject who is currently being treated for active TB infection is to be excluded.
    ? A subject who is currently being treated for latent TB infection can only be enrolled with confirmation of current incidence rates of multi drug resistant TB infection in the locale, documentation of an adequate treatment regimen, and with prior approval by the sponsor.
    7. Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 4 weeks after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
    8. Women of childbearing potential must have a negative pregnancy test prior to study enrollment.
    9. Subjects receiving non-prohibited concomitant medications for any reason, must be on a stable regimen, which is defined as not starting a new drug or changing dosage with 7 days or 5 half lives (whichever is longer) prior to first study dose.
    10. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily diary call, and other study procedures.
    11. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
    1.Edad mínima de 18 años. 2. Varones y mujeres con un diagnóstico documentado de CU ? 4 meses antes de su incorporación al estudio. En los documentos originales tiene que haber un informe de biopsia que respalde el diagnóstico.
    Pacientes con CU con actividad entre moderada e intensa, definida como una puntuación de Mayo total ? 6, con una puntuación de rectorragia ? 1 y una subpuntuación endoscópica ? 2 en la puntuación de Mayo determinada en los 7 días anteriores a la visita basal (visita 2). 4. Los pacientes deben haber presentado
    fracaso o ser intolerantes (han suspendido la medicación por un acontecimiento adverso, según la evaluación del investigador) a al menos uno de los siguientes tratamientos contra la CU: ? Corticoides orales. ? Azatioprina o 6-mercaptopurina (6-MP). ? Tratamiento anti-TNF: infliximab o adalimumab. 5. Los pacientes que estén recibiendo los siguientes tratamientos contra la CU podrán participar siempre que se hayan mantenido, y se prevea que vayan a mantenerse, con dosis estables durante el plazo designado: ? Dosis estable de 5-ASA o sulfasalazina por vía oral
    durante al menos 2 semanas antes del período basal y durante el período del estudio. ? Dosis estable de corticoides orales durante al menos 2 semanas antes del período basal y durante el período del estudio. ? Dosis estable de un tratamiento crónico contra la CU con antibióticos durante al menos 2 semanas antes del período basal y durante el período del estudio. 6. Ausencia de indicios de infección activa, latente o insuficientemente tratada por Mycobacterium tuberculosis (TB), según las definiciones siguientes: ? Prueba QuantiFERON?-TB Gold (QFT-G) In-Tube negativa o, en caso de no encontrarse disponible o de ser indeterminada al repetirla, prueba cutánea de Mantoux/derivado proteico purificado (PPD) (prueba de la tuberculina) según la práctica médica local habitual con un resultado de < 5
    mm de induración, realizada en una visita de selección dada o en los 3 meses anteriores a la misma. ? Radiografía de tórax, obtenida en una visita de selección dada o en los 3 meses anteriores a la misma, que no muestre alteraciones
    indicativas de infección TB activa, según la evaluación de un radiólogo cualificado Ausencia de antecedentes de infección TB activa o latente no tratada o insuficientemente tratada. ? Cuando un paciente ya haya recibido un ciclo adecuado de tratamiento por una infección TB latente (isoniazida durante 9 meses
    en una región en la que la tasa de TB multirresistente sea < 5% o un tratamiento alternativo aceptable) o activa ), no será necesario realizar una prueba de PPD ni QFT-G, pero deberá obtenerse una radiografía de tórax en caso de que no se haya realizado una en los 3 meses anteriores a una visita de selección dada. Antes de
    administrar la primera dosis del medicamento del estudio tendrá que obtenerse la confirmación de un tratamiento suficiente contra la TB. ? Se excluirá a los pacientes que estén recibiendo tratamiento por una infección TB activa. ? Un paciente que
    esté recibiendo tratamiento por una infección TB latente solo podrá ser incluido con la confirmación de la incidencia actualizada de infección TB multirresistente en la región, la confirmación de un régimen de tratamiento suficiente y la aprobación previa por parte del promotor. 7. Las mujeres en edad fértil tendrán que
    comprometerse a utilizar un método anticonceptivo muy eficaz durante todo el estudio y durante al menos 4 semanas después de la última dosis del tratamiento asignado. 8. Las mujeres en edad fértil han de tener una prueba de embarazo negativa antes de su inclusión en el estudio. 9. Los pacientes que estén recibiendo medicamentos concomitantes que no estén prohibidos por el motivo que sea deberán seguir un régimen estable, es decir, no podrán empezar a tomar ningún medicamento nuevo ni modificar la dosis en los 7 días o el período correspondiente
    a 5 semividas (lo que suponga más tiempo) antes de recibir la primera dosis del estudio. 10. Pacientes que se muestran dispuestos a cumplir las visitas programadas, el plan de tratamiento, las pruebas analíticas, las llamadas diarias
    relacionadas con el diario y otros procedimientos del estudio y son capaces de hacerlo. 11. Prueba de un documento de consentimiento informado, firmado y fechado personalmente, en el que se indique que el paciente (o su representante
    legal) ha sido informado de todos los aspectos pertinentes del estudio.
    E.4Principal exclusion criteria
    1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn?s disease.
    2. Subjects with disease limited to distal 15 cm.
    3. Subjects without previous treatment for UC (ie, treatment-naïve).
    4. Subjects receiving the following therapy within the designated time period or are expected to receive any of these therapies during the study period:
    ? Azathioprine, 6-mercaptopurine, or methotrexate within 2 weeks prior to baseline.
    ? Anti-TNF therapy (eg, infliximab, adalimumab, or certolizumab) within 8 weeks prior to baseline.
    ? Cyclosporine, mycophenolate, or tacrolimus within 8 weeks prior to baseline.
    ? Interferon therapy within 8 weeks prior to baseline.
    ? Intravenous corticosteroids within 2 weeks prior to baseline.
    ? Rectally administered formulation of corticosteroids or 5-ASA within 2 weeks prior to baseline.
    ? Anti-adhesion molecule therapy taken within 1 year (eg, natalizumab or any investigational anti-adhesion molecule therapy).
    5. Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
    6. Subjects with evidence of colonic adenomas or dysplasia. However, subjects with prior history of adenomatous polyps will be eligible if the polyps have been completely removed and the subjects are free of polyps at baseline.
    7. Subjects at risk for colorectal cancer must have a colonoscopy. Colonoscopy report and pathology report (if biopsies are obtained) must be available in the source document:
    ? If the subject is ?50 years of age, a colonoscopy within 10 years of the screening visit is required to exclude adenomatous polyps. Subjects whose adenomas have been completely excised at baseline will be eligible.
    ? If the subject has extensive colitis for ?8 years or disease limited to left side of colon (ie, distal to splenic flexure) for ?10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Subjects
    with dysplasia or cancer identified on biopsies will be excluded.
    8. Subjects who have had surgery for UC or in the opinion of the Investigator, are likely to require surgery for UC during the study period.
    9. Subjects who have positive stool examinations for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin at screening.
    10. Subjects with clinically significant infections currently or within 6 months of baseline (eg, those requiring hospitalization or parenteral antimicrobial therapy or opportunistic infections), a history of any infection requiring antimicrobial therapy within 2 weeks of baseline, or a history of any infection otherwise judged by the investigator to have the potential for exacerbation by participation in the study.
    11. Subjects with a history of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex.
    12. Subjects infected with human immunodeficiency virus (HIV) or hepatitis B or C viruses (Subjects with negative HBV surface antigen but positive HBV core antibody must have
    further testing for HBV surface antibody and if negative for HBV surface antibody, will be excluded from study enrollment).
    13. Subjects who have been vaccinated with live or attenuated vaccine within 6 weeks of baseline or scheduled to receive these vaccines during study period or within 6 weeks after last dose of study medication.
    14. Subjects with history of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder, as reported in some subjects on other immunosuppressive drugs), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current lymphatic disease.
    15. Subjects with malignancies or a history of malignancies, with the exception of adequately treated or excised non-metastatic basal cell or squamous cell cancer of the skin.
    16. Subjects receiving prohibited concomitant medications, including moderate to potent CYP3A inducers or inhibitors in the specified time periods prior to the first dose of study drug or are expected to receive any of these medications during the study period.
    17. Subjects with a history of bowel surgery within 6 months prior to baseline.
    18. Subjects with significant trauma or major surgery within 4 weeks of screening visit.
    19. Subjects likely to require any type of surgery during the study period.

    For the full list of exclusion criteria refer to section 4.2 of the protocol.
    Presencia de colitis indeterminada, colitis microscópica, colitis isquémica, colitis infecciosa o datos clínicos indicativos de enfermedad de Crohn. 2. Pacientes con enfermedad limitada a los 15 cm distales. 3. Pacientes sin tratamiento previo contra
    la CU 4. Pacientes que estén recibiendo los siguientes tratamientos dentro del plazo designado o que se prevea que vayan a recibir alguno de estos tratamientos durante el período del estudio: ? Azatioprina, 6-mercaptopurina o metotrexato en
    las 2 semanas anteriores al período basal. ? Tratamiento anti-TNF en las 8 semanas anteriores al período basal. ? Ciclosporina, micofenolato o tacrolimus en las 8 semanas anteriores al período basal. ? Tratamiento con interferón en las 8 semanas anteriores al período basal. ? Tratamiento con corticoides por vía intravenosa en las 2 semanas anteriores al período basal. ? Formulación de
    corticoides o 5-ASA administrada por vía rectal en las 2 semanas anteriores al período basal. ? Tratamiento con moléculas antiadherencia tomado en el año anterior (por ejemplo, natalizumab o cualquier molécula antiadherencia en investigación). 5. Pacientes que presenten signos clínicos de colitis fulminante o
    megacolon tóxico. 6. Pacientes con datos de adenomas o displasia del colon. Sin embargo, los pacientes con antecedentes de pólipos adenomatosos podrán participar siempre que se hayan extirpado completamente los pólipos y los pacientes se encuentren exentos de pólipos en el período basal. 7. Los pacientes con riesgo de cáncer colorrectal deberán someterse a una colonoscopia8. El informe de la colonoscopia y el informe de anatomía patológica (en caso de obtenerse biopsias) deberán encontrarse disponibles en los documentos originales:
    Cuando el paciente tenga ? 50 años de edad, se exigirá una colonoscopia realizada en los 10 años anteriores a la visita de selección para descartar pólipos adenomatosos. Los pacientes cuyos adenomas se hayan extirpado completamente
    en el período basal podrán participar. ? Cuando el paciente presente una colitis extensa durante ? 8 años o una enfermedad limitada al lado izquierdo del colon (es decir, distal a la flexura esplénica) durante ? 10 años, con independencia de la
    edad, se exigirá una colonoscopia realizada en el año anterior a la visita de selección para descartar displasia. Se excluirá a los pacientes con displasia o cáncer identificado en las biopsias. 8. Pacientes que se han sometido a cirugía para la CU o que, en opinión del investigador, es probable que precisen cirugía para la
    CU durante el período del estudio. 9. Pacientes que presenten estudios de heces positivos para patógenos entéricos, huevos o parásitos de patógenos o toxina de Clostridium difficile en la selección. 10. Pacientes con infecciones clínicamente importantes en la actualidad o en los 6 meses anteriores al período basal (por
    ejemplo, con necesidad de hospitalización o tratamiento antibiótico parenteral o infecciones oportunistas), antecedentes de cualquier infección con necesidad de tratamiento antibiótico en las 2 semanas anteriores al período basal o antecedentes
    de cualquier infección que el investigador considere que, por lo demás, tiene posibilidad de agravarse por el hecho de participar en el estudio. 11. Pacientes con antecedentes de más de un episodio de herpes zóster, antecedentes de herpes zóster diseminado o herpes simple diseminado. 12. Pacientes infectados por el virus de la inmunodeficiencia humana (VIH) o los virus de la hepatitis B (VHB) o C (los pacientes con antígeno de superficie del VHB negativo pero con anticuerpos positivos contra el antígeno nuclear del VHB deberán someterse a un análisis de anticuerpos contra el antígeno de superficie del VHB y, en caso de ser negativos, no podrán participar en el estudio). 13. Pacientes que hayan sido vacunados con una vacuna de microorganismos vivos o atenuados en las 6 semanas anteriores al período basal o que tengan previsto recibir estas vacunas durante el período del
    estudio o en las 6 semanas posteriores a la última dosis de medicación del estudio (véase el apartado 4.4.4). 14. Pacientes con antecedentes de cualquier trastorno linfoproliferativo (como el trastorno linfoproliferativo relacionado con el VEB que se
    describe en algunos pacientes que reciben otros inmunodepresores), antecedentes
    de linfoma, leucemia, trastornos mieloproliferativos, mieloma múltiple o signos y síntomas indicativos de enfermedad linfática activa Pacientes con neoplasias malignas o con antecedentes de neoplasias malignas, a excepción de un carcinoma basocelular o espinocelular de piel no metastásico debidamente tratado
    o extirpado. Para el resto de criterios, por favor vea el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The proportion of subjects in remission at Week 8. Remission is defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0.
    Proporción de pacientes en remisión en la semana 8. La remisión se define como
    una puntuación de Mayo total de 2 puntos o menos, sin subpuntuaciones
    individuales que superen 1 punto y con una subpuntuación de rectorragia de 0.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 8 of treatment
    Semana 8 del tratamiento
    E.5.2Secondary end point(s)
    Key Secondary Endpoint:
    ?The proportion of subjects achieving mucosal healing at Week 8. Mucosal healing is
    defined by Mayo endoscopic subscore of 0 or 1.

    Other Secondary Endpoints:
    ? The proportion of subjects achieving clinical response at Week 8. Clinical response is
    defined by a decrease from baseline in Mayo score of at least 3 points and at least
    30 percent, with an accompanying decrease in the subscore for rectal bleeding of at least 1 point or absolute subscore for rectal bleeding of 0 or 1.
    ? The proportion of subjects in endoscopic remission at Week 8. Endoscopic remission is defined by Mayo endoscopic subscore of 0.
    ? The proportion of subjects in clinical remission at Week 8. Clinical remission is defined
    by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point.
    ? The proportion of subjects in symptomatic remission at Week 8. Symptomatic remission is defined by a total Mayo score of 2 points or lower, with no individual subsocre exceeding 1 point, and both rectal bleeding and stool frequency subcore of 0.
    ? The proportion of subjects achieving deep remission at Week 8. Deep remission is
    defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding
    1 point and a zero on both endoscopic and rectal bleeding subscores.
    ? Partial Mayo scores and change from baseline over time.
    ? Change from baseline at Week 8 in total Mayo score.
    other exploratory, pharmacokinetic, biomarker, Health Outcome and safety endpoints are described within the protocol
    Proporción de pacientes que logren la cicatrización de la mucosa en la semana 8.
    La cicatrización de la mucosa se define como una subpuntuación endoscópica de Mayo de 0 o 1. Otros: Incidencia e intensidad de los acontecimientos adversos. ? Incidencia de infecciones graves (véase su definición en el apartado 7.2.10). ? Incidencia de la adición de hipolipemiantes. ? Incidencia e intensidad de las
    anomalías analíticas y variación con respecto al período basal de los valores analíticos. ? Incidencia de anomalías en las constantes vitales y variaciones con respecto al período basal de las constantes vitales. ? Incidencia de variaciones con importancia clínica en la exploración física con respecto al período basal. ? Incidencia de anomalías en el electrocardiograma (ECG). ? Resumen de los episodios cardiovasculares adjudicados. ? Resumen de las neoplasias malignas confirmadas por la interpretación del anatomopatólogo del laboratorio central.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All secondary endpoints are evaluated at Week 8 of treatment
    Todos los criterios de valoración son evaluados en la semana 8 del tratamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety 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 Yes
    E.6.13.1Other scope of the trial description
    Tolerability, Quality of life
    Tolerabilidad, calidad de vida
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA51
    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
    Australia
    Austria
    Belgium
    Brazil
    Canada
    Colombia
    Croatia
    Czech Republic
    Denmark
    Estonia
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Korea, Republic of
    Latvia
    Netherlands
    New Zealand
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Taiwan
    Ukraine
    United Kingdom
    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
    Last visit last subject
    ultima visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months7
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 445
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 204
    F.4.2.2In the whole clinical trial 545
    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)
    Subjects who complete the double-blind treatment and achieve clinical response at Week 8 are eligible to enter a double-blind maintenance study (A3921096).
    Los pacientes que hayan completado el tratamiento doble ciego y alacanzado
    respuesta clínica a la semana 8 son elegibles para participar en el estudio de
    mantenimiento doble ciego (A3921096). Los pacientes que hayan completado el
    tratamiento de doble ciego y no hayan alcanzado respuesta clínica son elegible
    para participar en el estudio abierto (A3921139)
    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 Decision2012-07-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-06-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-06-09
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