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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2008-003571-45
    Sponsor's Protocol Code Number:A3921043
    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:2008-08-01
    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 number2008-003571-45
    A.3Full title of the trial
    A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL
    GROUP, MULTI-CENTER STUDY TO INVESTIGATE THE SAFETY AND
    EFFICACY OF CP-690,550 IN SUBJECTS WITH MODERATE TO SEVERE
    CROHN’S DISEASE
    ESTUDIO ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, CON GRUPOS PARALELOS, MULTICÉNTRICO PARA INVESTIGAR LA SEGURIDAD Y LA EFICACIA DE CP-690,550 EN SUJETOS CON ENFERMEDAD DE CROHN DE MODERADA A GRAVE
    A.4.1Sponsor's protocol code numberA3921043
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer S.A
    B.1.3.4CountrySpain
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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 540-737-29-9
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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 nameCP-690,550
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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.3.10 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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Information not present in EudraCT
    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
    Enfermedad de Crohn
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9.1
    E.1.2Level LLT
    E.1.2Classification code 10011401
    E.1.2Term Crohn's disease
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    El objetivo principal es demostrar la eficacia de CP-690,550 como inductor de una respuesta clínica en sujetos con enfermedad de Crohn moderada a grave.
    E.2.2Secondary objectives of the trial
    1. Evaluar la seguridad y la tolerabilidad de CP-690,550 oral en sujetos con enfermedad de Crohn activa.
    2. Evaluar en profundidad la eficacia de CP-690,550 como inductor de la remisión clínica y definir el tiempo hasta la respuesta y la remisión en sujetos con enfermedad de Crohn activa.
    3. Definir la farmacocinética de CP-690,550 en sujetos con enfermedad de Crohn activa.
    4. Evaluar el efecto terapéutico de CP-690,550 sobre la calidad de vida en sujetos con enfermedad de Crohn activa.
    5. Demostrar la variación de los siguientes biomarcadores con respecto al valor basal: PCR y calprotectina fecal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Los sujetos deben tener al menos 18 años de edad.
    2. Sujetos de ambos sexos con signos clínicos de enfermedad de Crohn de al menos 3 meses de duración e intensidad moderada a grave en el momento basal, definida por una puntuación basal de 220 a 450, ambos inclusive, en el índice CDAI (índice de actividad de la enfermedad de Crohn).
    3. Visualización del tubo digestivo (radiología, gammagrafía o endoscopia) en los 24 meses previos a la selección para confirmar el diagnóstico y la extensión de la enfermedad de Crohn.
    4. Los sujetos que reciban actualmente los siguientes regímenes terapéuticos para la enfermedad de Crohn pueden ser elegidos siempre que mantengan una dosis estable durante el periodo de tiempo especificado:
    •Dosis estable de 5-ASA o sulfasalazina al menos durante las 3 semanas previas a la visita basal y durante el periodo de tratamiento del estudio.
    •Dosis estable de corticoides (prednisolona ≤30 mg o equivalente, budesonida ≤9 mg/kg) al menos durante las 2 semanas previas a la visita basal.
    •Dosis estable de antibióticos (p. ej., metronidazol, rifaximina) al menos durante las 2 semanas previas a la visita basal y durante el periodo de tratamiento del estudio.
    •Dosis estable de una formulación de corticoides para administración rectal o 5-ASA al menos durante las 2 semanas previas a la visita basal y durante el periodo de tratamiento del estudio.
    5. Sujetos que estén dispuestos a utilizar un método anticonceptivo doble durante el periodo de tratamiento del estudio y hasta la finalización de los procedimientos de seguimiento:
    •Si el sujeto es una mujer sexualmente activa en edad fértil, tanto ella como su pareja masculina tienen que utilizar simultáneamente dos de los métodos anticonceptivos eficaces citados en la sección 4.4.5.2. Las mujeres que deseen utilizar un método anticonceptivo no hormonal deberán haberlo empleado al menos desde 14 días antes de la primera dosis de la medicación del estudio.
    •Los varones no vasectomizados que tengan una pareja femenina en edad fértil deben estar dispuestos a utilizar preservativos, además de hacer que su pareja femenina utilice otro método anticonceptivo de los enumerados en la sección 4.4.5.4.
    6. Sujetos dispuestos a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio y capaces de hacerlo.
    7. Prueba de un documento de consentimiento informado, firmado y fechado en el que se indique que el sujeto ha sido informado de todos los aspectos pertinentes del estudio.
    E.4Principal exclusion criteria
    -Diagnóstico de colitis indeterminada, colitis ulcerosa (CU) o hallazgos clínicos que indiquen CU.
    - Sujetos con diagnóstico de enfermedad de Crohn que no hayan recibido tratamiento previamente (sin exposición previa al tratamiento)
    - Sujetos que reciban el siguiente tratamiento:
    •Azatioprina/6-mercaptopurina, metotrexato en los 7 días previos a la visita basal.
    •Ciclosporina, micofenolato, tacrolimus en las 4 semanas previas a la visita basal.
    •Tratamiento con interferón en las 8 semanas previas a la visita basal.
    •Tratamiento con anti-TNFα en las 8 semanas previas a la visita basal.
    - Sujetos que reciban actualmente natalizumab.
    - Antecedentes de estenosis obstructivas sintomáticas, ostomía, resección intestinal amplia (>100 cm) o síndrome del intestino corto.
    - Antecedentes de cirugía intestinal durante los 6 meses previos a la visita basal.
    - Coprocultivo que indique la presencia de infección por patógenos.
    - Sujetos con manifestaciones de trastornos hematopoyéticos
    - Bilirrubina total, AST o ALT más de dos veces por encima del límite superior de la normalidad en la visita de selección.
    - Filtración glomerular (FG) estimada ≤50 ml/min según la fórmula de Cockcroft-Gault.
    - Vacunación actual con alguna vacuna de virus vivos o antecedentes de vacunación con alguna vacuna de virus vivos en las 8 semanas previas a la visita basal.
    - Antecedentes de cualquier trastorno linfoproliferativo
    - Signos de infección activa o latente por Mycobacterium tuberculosis (TB)
    - Sujetos con infecciones importantes desde el punto de vista clínico actualmente o en los 6 meses previos a la visita
    - Administración previa de fármacos o tratamientos que reduzcan los linfocitos (como CamPath® [alemtuzab], alquilantes [p. ej., ciclofosfamida o clorambucilo], irradiación linfoide total, etc.).
    E.5 End points
    E.5.1Primary end point(s)
    El criterio principal de la eficacia es la proporción de sujetos con respuesta clínica en la semana 4, definida como una reducción de la puntuación del índice CDAI de al menos 70 puntos con respecto al valor basal.
    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 Yes
    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
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    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.8.3 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 EEA50
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LSLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months14
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months14
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Yes
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 68
    F.4.2.2In the whole clinical trial 136
    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 Decision2008-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-10-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2009-10-29
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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