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    Summary
    EudraCT Number:2010-022758-18
    Sponsor's Protocol Code Number:CNTO1275CRD3001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Temporarily Halted
    Date on which this record was first entered in the EudraCT database:2011-06-22
    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 number2010-022758-18
    A.3Full title of the trial
    A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Subjects with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to TNF Antagonist Therapy
    Estudio de Fase 3, aleatorizado, en doble ciego, controlado con placebo, de grupos paralelos y multicéntrico, para evaluar la seguridad y la eficacia del tratamiento de inducción con ustekinumab en sujetos con enfermedad de Crohn de actividad moderada a severa que han fracasado o que presentan intolerancia al tratamiento con un antagonista del TNF
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study to Evaluate the Safety and Efficacy of Ustekinumab in Patients with Moderately to Severely Active Crohn's Disease Who Have Failed or Are Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy
    Estudio para evaluar la seguridad y eficacia de ustekinumab en pacientes con enfermedad de Crohn de actividad moderada a severa que han fracasado o que presentan intolerancia al tratatamiento con un antagonista del factor de necrosis tumoral (TNF)
    A.3.2Name or abbreviated title of the trial where available
    UNITI 1
    A.4.1Sponsor's protocol code numberCNTO1275CRD3001
    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 SponsorJanssen-Cilag International N.V.
    B.1.3.4CountryBelgium
    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 supportCentocor R&D
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333 CM
    B.5.3.4CountryNetherlands
    B.5.4Telephone number+310715242166
    B.5.5Fax number+310715242110
    B.5.6E-mailClinicalTrialsEU@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 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 nameUstekinumab
    D.3.2Product code CNTO1275
    D.3.4Pharmaceutical form Solution for injection
    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 INNUstekinumab
    D.3.9.1CAS number 815610-63-0
    D.3.9.2Current sponsor codeCNTO1275
    D.3.9.3Other descriptive nameN/A
    D.3.9.4EV Substance CodeSUB27761
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.5 to 5.5
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal Antibody
    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 placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Moderately to severely active Crohn's disease
    Enfermedad de Crohn de actividad moderada a severa
    E.1.1.1Medical condition in easily understood language
    Digestive System and Oral Physiological Phenomena
    Transtorno fisiológico del aparato digestivo.
    E.1.1.2Therapeutic area Diseases [C] - Immune System Diseases [C20]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.0
    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
    The primary objectives are:
    - To evaluate the efficacy of IV induction regimens of Ustekinumab in inducing clinical response in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more tumor necrosis factor (TNF) antagonist therapies.
    - To evaluate the safety of IV induction regimens of Ustekinumab in subjects with moderately to severely active Crohn's disease who have failed or are intolerant to one or more TNF antagonist therapies.
    Los objetivos principales son:
    ? Evaluar la eficacia de las pautas de inducción IV de ustekinumab para inducir la respuesta clínica en sujetos con enfermedad de Crohn de actividad moderada a severa que han fracasado o que presentan
    intolerancia a uno o más tratamientos con antagonistas del factor de necrosis tumoral (TNF).
    ? Evaluar la seguridad de las pautas de inducción IV de ustekinumab en sujetos con enfermedad de Crohn de actividad moderada a severa
    E.2.2Secondary objectives of the trial
    The secondary objectives are:
    - To evaluate the efficacy of IV induction regimens of Ustekinumab in inducing clinical remission.
    - To evaluate the efficacy of IV induction regimens of Ustekinumab in improving disease-specific health-related quality of life.
    - To evaluate the pharmacokinetics and pharmacodynamics of Ustekinumab therapy, including changes in C-reactive protein (CRP), fecal calprotectin, fecal lactoferrin, and other pharmacodynamic biomarkers.
    - To provide, along with induction study CNTO1275CRD3002, the target study population to be evaluated in the maintenance study CNTO1275CRD3003.
    Los objetivos secundarios son:
    ? Evaluar la eficacia de las pautas de inducción IV de ustekinumab en la inducción de la remisión clínica.
    ? Evaluar la eficacia de las pautas de inducción IV de ustekinumab en la mejora de la calidad de vida relacionada con la salud específica de la enfermedad.
    ? Evaluar la farmacocinética y la farmacodinamia del tratamiento con ustekinumab, como las variaciones de la proteína C reactiva (CRP), la calprotectina fecal, la lactoferrina fecal y otros biomarcadores farmacodinámicos.
    ? Junto con el estudio sobre inducción CNTO1275CRD3002, aportar la población objetivo que se evaluará en el estudio de mantenimiento CNTO1275CRD3003.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a man or woman ? 18 years of age.

    2. Have Crohn's disease or fistulizing Crohn's disease of at least 3 months' duration, with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy.

    3. Have active Crohn's disease, defined as a baseline CDAI score of ? 220 and ? 450.

    4. Have received infliximab, adalimumab, or certolizumab pegol at a dose approved for the treatment of Crohn's disease and
    a. Did not respond initially;
    OR
    b. Responded initially but then lost response with continued therapy;
    OR
    c. Were intolerant to the medication.

    5. Adhere to the following requirements for concomitant medication for the treatment of Crohn's disease. The following medications are permitted provided doses meeting the requirements below are stable for or have been discontinued at least 3 weeks prior to baseline (Week 0), unless otherwise specified.
    a. Oral 5-ASA compounds.
    b. Oral corticosteroids at a prednisone-equivalent dose of ? 40 mg/day or ? 9 mg/day of budesonide.
    c. Antibiotics being used as a primary treatment of Crohn's disease.
    d. Subjects receiving conventional immunomodulators must have been taking them for ? 12 weeks, and on a stable dose for a least 4 weeks prior to baseline.

    6. Have screening laboratory test results within the parameters mentioned in the protocol:

    7. Are considered eligible according to the following TB screening criteria:
    a. Have no history of latent or active TB prior to screening. Exceptions are made for subjects currently receiving treatment for latent TB, if there is no evidence of active TB, or who have a history of latent TB and documentation of having completed adequate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous TB treatment and provide appropriate documentation.
    b. Have no signs or symptoms suggestive of active TB upon medical history and/or physical examination.
    c. Have had no recent close contact with a person with active TB or, if there has been such contact, will be referred to a physician specializing in TB to undergo additional evaluation and, if warranted, receive appropriate treatment for latent TB prior to or simultaneously with the first administration of study agent.
    d. Within 2 months prior to the first administration of study agent, either have negative QuantiFERON-TB Gold test, or have a newly identified positive QuantiFERON-TB Gold test in which active TB has been ruled out, and for which appropriate treatment for latent TB has been initiated either prior to or simultaneously with the first administration of study agent. A negative tuberculin skin test is additionally required if the QuantiFERON-TB gold test is not approved/registered in that country. The QuantiFERON-TB Gold In-Tube test is not required at screening for subjects with a history of latent TB and appropriate treatment as described in 7a.
    e. Have a chest radiograph, taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current active TB or old inactive TB.

    8. If a woman, before entry she must be:
    a. Postmenopausal, defined as
    1) > 45 years of age with amenorrhea for at least 18 months,
    OR
    2) > 45 years of age with amenorrhea for at least 6 months and a serum follicle stimulating hormone (FSH) level > 40 IU/mL
    OR
    b. Menstrual
    1) Surgically sterile, or
    2) If heterosexually active, practicing a highly effective method of birth control, including hormonal prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method, or male partner sterilization, consistent with local regulations regarding use of birth control methods for subjects participating in clinical trials, for the duration of their participation in the study and for 20 weeks after receiving study agent, or
    3) Not heterosexually active.

    9. If a woman of childbearing potential, she must have a negative serum ?-human chorionic gonadotropin (?-hCG) pregnancy test at screening; and a negative urine pregnancy test at Week 0.

    10. If a man and heterosexually active with a woman of childbearing potential, he must agree to use a double barrier method of birth control and to not donate sperm during the study and for 20 weeks after receiving study agent.

    11. Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.

    12. Sign an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study, and intend to participate in the maintenance study if eligible.
    1. Ser varón o mujer de ? 18 años de edad.
    2. Presentar enfermedad de Crohn o enfermedad de Crohn fistulizante de al menos 3 meses de duración, con colitis, ileítis o ileocolitis, confirmadas en cualquier momento anterior por radiografía, histología y/o endoscopia.
    3. Presentar enfermedad de Crohn activa, que se define por un CDAI basal de ? 220 y ? 450.
    4. Haber recibido infliximab, adalimumab o certolizumab pegol en una dosis aprobada para el tratamiento de la enfermedad de Crohn y
    a. No haber respondido inicialmente
    O BIEN
    b. Haber perdido la respuesta al continuar el tratamiento después de haber respondido inicialmente
    O BIEN
    c. Ser intolerantes a la medicación.
    5. Cumplir los siguientes requisitos sobre la medicación concomitante para el tratamiento de la enfermedad de Crohn. Se permiten los siguientes medicamentos, siempre que las dosis cumplan los siguientes requisitos y sean estables desde al menos 3 semanas antes del momento basal (semana 0) o se hayan dejado de administrar antes de ese período, salvo que se indique otra cosa.
    a. Compuestos 5-ASA orales.
    b. Corticosteroides orales en una dosis equivalente de prednisona de ? 40 mg/día o de ? 9 mg/día de budesónida.
    c. Uso de antibióticos como tratamiento principal de la enfermedad de Crohn.
    d. Los sujetos que reciban inmunomoduladores convencionales deberán haberlos recibido durante ? 12 semanas, sin haber cambiado la dosis en las 4 semanas previas al momento basal, como mínimo.
    6. Los resultados de los análisis de la selección deberán estar dentro de los límites mencionados en el protocolo
    7. Con respecto a la TB, los sujetos deberán reunir los siguientes requisitos:
    a. No presentar antecedentes de TB latente o activa antes de la selección. Se harán excepciones con los sujetos que reciban tratamiento para la TB latente en la actualidad, si no hay indicios de TB activa, o con los que presenten antecedentes de TB latente y
    documentación de haber recibido el tratamiento adecuado completo para dicha enfermedad en los 3 años previos a la administración de la primera dosis del fármaco del estudio. Será responsabilidad del investigador verificar la idoneidad del tratamiento antituberculoso previo y aportar la documentación adecuada.
    b. No presentar signos o síntomas indicativos de TB activa, según la anamnesis y/o la exploración física.
    c. No haber tenido contacto íntimo reciente con una persona con TB activa o, si ha habido tal contacto, se le remitirá a un especialista en TB para someterse a una evaluación más completa y, si fuera necesario, para recibir el tratamiento adecuado para la TB latente antes o a la vez que la primera administración del fármaco del estudio.
    d. En los 2 meses previos a la primera administración del fármaco del estudio, presentar un resultado negativo de la prueba QuantiFERON-TB Gold o haber dado un resultado positivo nuevo en dicha prueba si se ha descartado la TB activa y el sujeto empieza a recibir tratamiento adecuado para la TB latente antes o a la vez que la primera administración del fármaco del estudio. También se precisa un resultado negativo de la prueba cutánea de la tuberculina si la prueba QuantiFERON-TB Gold no está aprobada/registrada en ese país. La prueba QuantiFERON-TB Gold In-Tube no será necesaria en la selección de los sujetos con antecedentes de TB latente que hayan
    recibido tratamiento adecuado, como se describe en el criterio de inclusión 7a.
    e. Haberse hecho una radiografía de tórax en los 3 meses previos a la primera administración del fármaco del estudio, que interpretará un radiólogo cualificado, confirmando la ausencia de TB activa actual o de
    TB inactiva antigua.
    8. Si se trata de una mujer, para poder entrar en el estudio deberá:
    a. Estar en la posmenopausia, es decir
    1) tener > 45 años de edad y amenorrea desde al menos 18 meses antes,
    O BIEN
    2) tener > 45 años de edad y amenorrea desde al menos 6 meses antes, con una concentración de folitropina (FSH) > 40 UI/ml
    O BIEN
    b. Estar en edad menstrual y
    1) Haber sido esterilizada por métodos quirúrgicos o bien
    2) Si mantiene actividad sexual heterosexual, deberá utilizar un método anticonceptivo muy eficaz, como medicamentos anticonceptivos hormonales orales, anticonceptivos inyectables, anticonceptivos en parches, dispositivo intrauterino, método de doble
    barrera o esterilización de la pareja masculina, compatible con las normas locales sobre el uso de anticonceptivos por sujetos participantes en ensayos clínicos, durante la participación en el estudio y hasta 20 semanas después de recibir el fármaco del estudio, o bien
    3) No mantener relaciones sexuales heterosexuales.
    9. Si se trata de una mujer potencialmente fértil deberá dar un resultado negativo en una prueba de embarazo de la gonadotropina coriónica humana beta (?-hCG) en suero en la selección, y un resultado negativo en una prueba de embarazo en orina en la semana 0.
    REFIERASE AL PROTOCOLO PARA VER RESTO DE CRITERIOS
    E.4Principal exclusion criteria
    1. Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the CDAI to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab.

    2. Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery. Subjects with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified.

    3. Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months prior to baseline.

    4. Has a draining stoma or ostomy.

    5. Has received any of the prescribed medications or therapies within the specified period (mentioned in the protocol).

    6. Have a stool culture or other examination positive for an enteric pathogen, including Clostridium difficile toxin, in the last 4 months unless a repeat examination is negative and there are no signs of ongoing infection with that pathogen.

    7. Has previously received a biologic agent targeting IL-12 or IL-23, including but not limited to ustekinumab (CNTO 1275) or briakinumab (ABT-874).

    8. Has received a Bacille Calmette-Guérin (BCG) vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks of baseline.

    9. Has a history of, or ongoing, chronic or recurrent infectious disease, including but not limited to, chronic renal infection, chronic chest infection, recurrent urinary tract infection, or open, draining, or infected skin wounds or ulcers.

    10. Has current signs or symptoms of infection. Established nonserious infections need not be considered exclusionary at the discretion of the investigator.

    11. Has a history of serious infection, including any infection requiring hospitalization or IV antibiotics, for 8 weeks prior to baseline.

    12. Has evidence of a herpes zoster infection ? 8 weeks prior to baseline.

    13. Has a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening. Refer to inclusion criteria for information regarding eligibility with a history of latent TB.

    14. Has evidence of current active infection, including but not limited to TB (exceptions see protocol).

    15. Has or ever has had a nontuberculous mycobacterial infection or serious opportunistic infection.

    16. Is known to be infected with HIV, hepatitis B, or hepatitis C.

    17. Has severe, progressive, or uncontrolled renal, hepatic, hematological, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease, or signs and symptoms thereof.

    18. Has a transplanted organ.

    19. Has a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and/or splenomegaly.

    20. Has any known malignancy or has a history of malignancy.

    21. Has previously undergone allergy immunotherapy for prevention of anaphylactic reactions.

    22. Is unable or unwilling to undergo multiple venipunctures because of poor tolerability or lack of easy access to veins.

    23. Is known to have had a substance abuse problem within the previous 12 months prior to baseline.

    24. Has known allergies, hypersensitivity, or intolerance to ustekinumab or its excipients.

    25. Are currently or intending to participate in any other study using an investigational agent or procedure during participation in this study.

    26. Is a woman who is pregnant, or breast-feeding, or planning to become pregnant or is a man who plans to father a child while enrolled in this study or within 20 weeks after the last dose of study agent.

    27. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject or that could prevent, limit, or confound the protocol-specified assessments.
    1. Presenta complicaciones de la enfermedad de Crohn como estenosis sintomática, síndrome del intestino corto u otras manifestaciones que puedan precisar cirugía previsiblemente, impedir el uso del CDAI para evaluar la respuesta al tratamiento o alterar la capacidad de evaluar el efecto del tratamiento con ustekinumab.
    2. Presenta un absceso en la actualidad, o se sospecha que lo presenta. Los abscesos cutáneos y perianales recientes no serán motivo de exclusión si se drenan y reciben el tratamiento adecuado al menos 3 semanas antes del momento basal, u 8 semanas antes del momento basal en el caso de los abscesos intraabdominales, siempre que no se prevea la necesidad de una intervención quirúrgica. Podrán participar sujetos con fístulas activas si no se prevé la necesidad de una intervención quirúrgica ni se identifican abscesos en la actualidad.
    3. Ha sido sometido a cualquier tipo de resección intestinal en los 6 meses previos, o a cualquier otra intervención intrabdominal en los 3 meses previos al momento basal.
    4. Presenta un estoma o porta una bolsa de colostomía o ileostomía en funcionamiento.
    5. Ha recibido cualquiera de los siguientes medicamentos o tratamientos recetados en el período que indica el protocolo
    6. Presenta coprocultivo u otra prueba positiva para un patógeno entérico, incluida la toxina de Clostridium difficile, en los últimos 4 meses, salvo que se repita la prueba y el resultado sea negativo, sin signos de infección por ese patógeno en la actualidad.
    7. Ha recibido anteriormente un producto biológico que actúe sobre IL-12 o IL-23, como ustekinumab (CNTO 1275) o briakinumab (ABT-874), entre otros.
    8. Ha sido vacunado con el bacilo de Calmette-Guérin (BCG) en los 12 meses previos al momento basal, o con cualquier tipo de vacuna con bacterias o virus vivos en las 12 semanas previas al momento basal.
    9. Tiene o ha tenido enfermedades infecciosas crónicas o recurrentes, como infección renal crónica, infección respiratoria crónica, infección urinaria recurrente, herida quirúrgica abierta, con drenaje o infectada,
    o úlcera, entre otras.
    10. Presenta signos o síntomas de infección en la actualidad. Las infecciones no graves establecidas no serán motivo de exclusión si así lo estima el investigador.
    11. Tiene antecedentes de infección grave, incluida cualquier infección que precise hospitalización o antibióticos IV, en las 8 semanas previas al momento basal.
    12. Presenta indicios de infección por herpes zóster ? 8 semanas antes del momento basal.
    13. Tiene antecedentes de infección granulomatosa latente o activa antes de la selección, como histoplasmosis o coccidioidomicosis. Puede consultar información sobre la admisión de sujetos con antecedentes de TB latente en los criterios de inclusión.
    14. Presenta indicios de infección activa en la actualidad, incluida la TB(ver excepciones en el protocolo).
    15. Padece o ha padecido infección por micobacterias no tuberculosas u otra infección oportunista grave.
    16. Presenta infección conocida por el VIH o por los virus de la hepatitis B o C.
    17. Presenta enfermedad renal, hepática, hematológica, endocrina, pulmonar, cardíaca, neurológica, cerebral o psiquiátrica grave, progresiva o mal controlada, o signos y síntomas de padecerla.
    18. Ha recibido un trasplante de órgano.
    19. Tiene antecedentes de enfermedad linfoproliferativa, como linfoma, o signos y síntomas indicativos de posible enfermedad linfoproliferativa, como linfadenopatía y/o esplenomegalia.
    20. Presenta cualquier trastorno maligno o antecedentes de trastorno maligno.
    21. Ha recibido previamente inmunoterapia para la prevención de reacciones alérgicas.
    22. No puede o no está dispuesto a someterse a venopunciones múltiples, por mala tolerancia o por carecer de acceso fácil.
    23. Ha presentado una toxicomanía en los 12 meses previos al momento basal.
    24. Presenta alergias, hipersensibilidad o intolerancia a ustekinumab o a sus excipientes.
    25. Participa o tiene previsto participar en otro estudio con un fármaco o procedimiento en investigación durante su participación en este estudio.
    26. Es una mujer embarazada o en período de lactancia o que tiene previsto quedarse embarazada, o es un varón que pretende engendrar un hijo durante su participación en este estudio o hasta 20 semanas después de recibir la última dosis del fármaco del estudio.
    27. Presenta cualquier circunstancia que, en opinión del investigador, hace que la participación no sea lo mejor para el sujeto o que pueda impedir, limitar o confundir las evaluaciones que se especifican en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is clinical response at Week 6, defined as a reduction from baseline in the CDAI score of ? 100 points. Subjects with a baseline CDAI score of ? 220 to ? 248 points are considered to be in clinical response if a CDAI score of < 150 is attained.
    El criterio de valoración principal es la respuesta clínica en la semana 6, definida como una reducción del CDAI de ?100 puntos con respecto al valor basal. Se considera que los sujetos con un CDAI basal de ? 220 a ? 248 puntos presentan respuesta clínica si alcanzan un CDAI de < 150.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At week 6
    En la semana 6
    E.5.2Secondary end point(s)
    The major secondary endpoints, in order of importance, are:
    1. Clinical remission at Week 8, defined as a CDAI score of < 150 points.
    2. Clinical response at Week 8.
    3. 70-point response at Week 6, defined as a reduction from baseline in the CDAI score of ? 70 points.
    4. 70-point response at Week 3.
    Los criterios de valoración secundarios mayores, por orden de importancia, son:
    1. Remisión clínica en la semana 8, definida por un CDAI de < 150 puntos.
    2. Respuesta clínica en la semana 8.
    3. Respuesta de 70 puntos en la semana 6, definida como una reducción del CDAI de ? 70 puntos con respecto al valor basal.
    4. Respuesta de 70 puntos en la semana 3.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At week 3, 6 and 8
    En la semana 3, 6 y 8
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA77
    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
    Brazil
    Canada
    European Union
    Iceland
    Israel
    Japan
    Korea, Republic of
    New Zealand
    Serbia
    South Africa
    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
    Subjects entering maintenance study CNTO1275CRD3003 will be considered to have completed induction study CNTO1275CRD3001 if they've completed the Week 8 visit.

    Subjects not entering maintenance study CNTO1275CRD3003 will be considered to have completed induction study CNTO1275CRD3001 if they've completed the safety follow up visit approximately 20 weeks after study agent administration at Week 0.
    Se considerará que los sujetos que entren en el estudio de mantenimiento CNTO1275CRD3003 habrán completado el estudio de inducción CNTO1275CRD3001 si han completado la visita de la semana 8.
    Se considerará que los sujetos que no entren en el estudio de mto. CNTO1275CRD3003 habrán completado el estudio de inducción CNTO1275CRD3001 si han completado la última visita de seguimiento de la seguridad, aprox. 20 semanas después de la administración del fármaco del estudio en la semana 0.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    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: 625
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 257
    F.4.2.2In the whole clinical trial 675
    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 may be eligible to participate in an additional trial (CNTO1275CRD3003) where they may have an opportunity to receive study agent in a blinded fashion.
    Los paciente podrán sen seleccionados para participar en un ensayo adicional (CNTO1275CRD3003) donde podrán tener oportunidad de recibir el fármaco de una forma ciega.
    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 Decision2011-09-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2011-08-04
    P. End of Trial
    P.End of Trial StatusTemporarily Halted
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