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    EudraCT Number:2011-003622-27
    Sponsor's Protocol Code Number:A3921086
    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:2012-02-16
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-003622-27
    A.3Full title of the trial
    "Estudio de Extensión abierto de CP-690,550 como tratamiento de mantenimiento en pacientes con enfermedad de Crohn"
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    "Estudio de Extensión abierto de CP-690,550 como tratamiento de mantenimiento en pacientes con enfermedad de Crohn"
    A.4.1Sponsor's protocol code numberA3921086
    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
    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.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form Film-coated 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.3.10 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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Crohn's Disease
    Enfermedad de Crohn
    E.1.1.1Medical condition in easily understood language
    Crohn's Disease
    Enfermedad de Crohn
    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 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 objective of the study is to assess the safety and tolerability of long-term open-label (OL) CP-690,550 therapy in subjects with CD.
    El objetivo principal del estudio es evaluar la seguridad y la tolerabilidad del tratamiento en régimen abierto a largo plazo con CP-690,550 en pacientes con EC.
    E.2.2Secondary objectives of the trial
    ? To evaluate the effect of OL CP-690,550 maintenance therapy on clinical remission in subjects with CD.

    ? To evaluate the effect of OL CP-690,550 maintenance therapy on quality-of-life in subjects with CD.

    ? To evaluate the effect of OL CP-690,550 maintenance therapy on biomarkers as measured by CRP and fecal calprotectin.
    ?Evaluar el efecto en tratamiento de mantenimiento en abierto con CP-690,550 sobre la remisión clínica de los pacientes con EC.
    ?Evaluar el efecto del tratamiento de mantenimiento en abierto con CP-690,550 sobre la calidad de vida de los pacientes con EC.
    ?Evaluar el efecto de CP-690,550 como tratamiento de mantenimiento en abierto sobre los biomarcadores, medido por la PCR y la calprotectina fecal.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
    1. Subjects who complete 26-week maintenance treatment of the A3921084 study or subjects who withdraw early due to A3921084 study treatment failure
    2. Women of childbearing potential must test negative for pregnancy prior to study enrolment.
    3. Sexually active females of childbearing potential are required to use adequate contraceptive methods during the study period and until completion of the follow-up procedures. No specific contraceptive measures are required in male subjects during study participation (Further description of the requirements and a list of contraceptives considered effective and acceptable for use in this trial are found in Section 4.4 Life Style Guidelines of the protocol).
    4. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
    5. Evidence of a personally signed and dated informed consent document(s) indicating that the subject has been informed of all pertinent aspects of the study.
    1.Sujetos que completen el tratamiento de mantenimiento de 26 semanas del estudio A3921084 o sujetos que se retiren prematuramente por fracaso del tratamiento en el estudio A3921084 (véase el Apéndice 5).
    2.Las mujeres en edad fértil deberán tener un resultado negativo en una prueba de embarazo antes de ser incluidas en el estudio.
    3.Las mujeres en edad fértil sexualmente activas deberán utilizar métodos anticonceptivos adecuados durante el estudio y hasta la finalización de los procedimientos de seguimiento. Los varones no están obligados a adoptar medidas anticonceptivas específicas durante su participación en el estudio (en el apartado 4.4 Pautas sobre los hábitos de vida se recoge una descripción más detallada de los requisitos y una lista de anticonceptivos que se consideran eficaces y aceptables para este ensayo).
    4.Sujetos dispuestos a cumplir las visitas programadas, el plan de tratamiento, los análisis clínicos y otros procedimientos del estudio, y capaces de hacerlo.
    5.Prueba de un documento de consentimiento informado, firmado y fechado personalmente en el que se indique que el sujeto ha sido informado de todos los aspectos pertinentes del estudio.
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will be excluded from the study:
    1. Subjects who have been discontinued due to protocol violation(s) (as determined by the Sponsor) in the A3921084 study.
    2. Subjects who were discontinued from the A3921084 study due to an adverse event.
    3. Subjects likely to require any non-elective surgery or surgery requiring overnight stay (with the exception of minor same day outpatient procedures that will not interfere with study drug dosing).
    4. Evidence of active (draining) fistulae, intrabdominal or perineal collection or abscess at Baseline (MRI imaging is not required for entry to this study unless clinically indicated).
    5. Subjects with evidence of or suspected liver disease ie, liver injury due to methotrexate or primary sclerosing cholangitis.
    6. Subjects with evidence of blood dyscrasias at Baseline visit (as assessed by the laboratory results from Week 26 or early discontinuation visit from the A3921084 study):
    ? Hemoglobin levels <9.0 g/dL or hematocrit <30%.
    ? An absolute white blood cell (WBC) count of <3.0 x 10 to the power of 9/L (<3000/mm3) or absolute neutrophil count of <1.2 X 10 to the power of 9/L (<1200/mm3).
    ? Thrombocytopenia, as defined by a platelet count <100 x 10 to the power of 9/L (<100,000/mm3).
    7. Subjects who have been scheduled to receive any live or attenuated virus vaccination during study period and for 6 weeks after last dose of study drug. (see Section 4.4.4 of the protocol for further information on avoidance of household contacts who may be vaccinated with live virus).
    8. Women who are pregnant or lactating, or planning pregnancy during the study period.
    9. Subjects with estimated GFR ?40 mL/min based on Cockcroft-Gault calculation from Week 26 or early discontinuation visit from the A3921084 study.
    10. Subjects with total bilirubin, AST or ALT more than 1.5 times the upper limit of normal from Week 26 or early discontinuation visit from the A3921084 study.
    11. Subjects with current or recent history of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including uncontrolled hypercholesterolemia), endocrine, pulmonary, cardiac, or neurological disease.
    12. Baseline 12-lead ECG (from Week 26 or early discontinuation visit from the A3921084 study) that demonstrates clinically relevant abnormalities which may affect subject safety or interpretation of study results (ie, baseline QTcF >450 ms, complete LBBB, acute or indeterminate age myocardial infarction, 2nd-3rd degree AV block, or serious bradyarrhythmias or tachyarrhythmias; see Appendix 3 of the protocol).
    13. Subjects who are expected to receive prohibited concomitant medications (see Appendix 2 of the protocol) including medications that are either moderate to potent CYP3A4 inducers or inhibitors during the study period.
    14. Subjects who, in the opinion of the investigator or Pfizer, will be uncooperative or unable to comply with study procedures.
    15. Subjects who are investigational site staff members or relatives of those site staff members or subjects who are Pfizer employees directly involved in the conduct of the trial.
    16. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
    1.Sujetos a los que se ha retirado por desviaciones del protocolo (según lo determinado por el promotor) en el estudio A3921084.
    2.Pacientes que abandonaron el estudio A3921084 por un acontecimiento adverso.
    3.Sujetos con probabilidades de necesitar cualquier intervención quirúrgica no programada o una intervención que requiere una estancia nocturna (excepto los procedimientos ambulatorios menores de un solo día que no interfieren en la administración del fármaco del estudio).
    4.Prueba de fístulas activas (drenantes), acumulación o absceso intraabdominal o perineal en el momento basal (no se requiere una RM a la entrada en este estudio, a menos que esté clínicamente indicado).
    5.Sujetos con signos o sospecha de enfermedad hepática, es decir, lesión hepática debida al tratamiento con metotrexato o a colangitis esclerosante primaria.
    6.Sujetos con signos de discrasias sanguíneas en la visita basal (según los resultados de laboratorio de la semana 26 o de la visita de retirada prematura del estudio A3921084):
    ?Hemoglobina < 9,0 g/dl o hematocrito < 30 %
    ?Recuento absoluto de leucocitos <3,0 x 109/l (<3000/mm3) o recuento absoluto de neutrófilos <1,2 x 109/l (<1200/mm3).
    ?Trombocitopenia, definida por un recuento de plaquetas < 100 x 109/l (<100.000/mm3)
    7.Sujetos programados para recibir una vacuna de virus vivos o atenuados durante el estudio y durante 6 semanas después de la última dosis del fármaco del estudio. (Véase el apartado 4.4.4 para obtener más información con respecto a la necesidad de evitar los contactos domiciliarios con personas vacunadas con virus vivos.)
    8.Mujeres embarazadas o lactantes o que tengan intención de quedarse embarazadas durante del periodo del estudio.
    9.Sujetos con una FG estimada ? 40 ml/min según la fórmula de Cockcroft-Gault desde la semana 26 o de retirada prematura del estudio A3921084 (véase el Apéndice 4).
    10.Sujetos con bilirrubina total, AST o ALT más de 1,5 veces por encima del límite superior de la normalidad desde la semana 26 o la retirada prematura del estudio A3921084.
    11.Sujetos con presencia o antecedentes recientes de enfermedad renal, hepática, hematológica, digestiva, metabólica (incluida la hipercolesterolemia no controlada), endocrina, pulmonar, cardiaca o neurológica grave, progresiva o no controlada.
    12.ECG de 12 derivaciones basal (desde la semana 26 o en la retirada prematura del estudio A3921084) que presente anomalías de importancia clínica que puedan afectar a la seguridad del sujeto o la interpretación de los resultados del estudio (QTcF >450 ms, BRI completo, infarto de miocardio agudo o de edad indeterminada, bloqueo AV de 2º o 3er grado o bradiarritmias o taquiarritmias graves; véase el apéndice 3).
    13.Sujetos que esté previsto que reciban medicamentos concomitantes prohibidos (véase el Apéndice 2), incluidos los fármacos que sean inductores o inhibidores moderados o potentes de la CYP3A4 durante el período del estudio.
    14.Sujetos que, en opinión del investigador o de Pfizer, no vayan a cooperar o no puedan cumplir los procedimientos del estudio.
    15.Sujetos que sean miembros del personal del centro de investigación o familiares de los miembros del personal del centro o empleados de Pfizer que intervengan directamente en la realización del ensayo.
    16.Otro proceso médico o psiquiátrico agudo o crónico grave o anomalía analítica que pueda aumentar el riesgo asociado a la participación en el estudio o a la administración del producto en investigación o que pueda interferir en la interpretación de los resultados del estudio y que, en opinión del investigador, haga inadecuada la inclusión del sujeto en este estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Safety Endpoints
    - Incidence and severity of adverse events.
    - Incidence and severity of clinical laboratory abnormalities, and change from baseline in clinical laboratory values.
    - Incidence of clinically significant changes in physical examination from baseline.
    - Incidence of vital sign abnormalities and changes from baseline in vital sign measures.
    - Incidence of electrocardiogram (ECG) abnormalities and change from baseline in ECG measurements during treatment.
    - Summary of adjudicated cardiovascular endpoints.
    - Summary of malignancies confirmed by central laboratory pathologist over-read of biopsies.
    Criterios de valoración de la seguridad
    ?Incidencia e intensidad de los acontecimientos adversos.
    ?Incidencia e intensidad de las alteraciones analíticas y variaciones respecto al valor basal de los valores de laboratorio.
    ?Incidencia de variaciones clínicamente importantes en la exploración física con respecto al momento basal.
    ?Incidencia de alteraciones de las constantes vitales y variaciones de las constantes vitales con respecto al momento basal.
    ?Incidencia de anomalías electrocardiográficas (ECG) y variaciones con respecto al valor basal de las mediciones del ECG durante el tratamiento.
    ?Resumen de los criterios de valoración cardiovasculares adjudicados.
    ?Resumen de las neoplasias malignas confirmadas por la interpretación de las biopsias por el anatomopatólogo del laboratorio central.
    E.5.1.1Timepoint(s) of evaluation of this end point
    All safety endpoints are measured at every clinic visit throughout the duration of the study (52 weeks)
    Todas las variables de seguridad se determinan en todas las visitas a lo largo del ensayo
    E.5.2Secondary end point(s)
    Efficacy endpoints

    - Sustained clinical remission at both Week 24 and Week 48.
    - The proportion of all subjects in clinical remission and sustained clinical remission at Week 48.
    - The proportions of subjects in clinical remission and sustained clinical remission among subjects in clinical remission at A3921086 baseline.
    - The proportion of subjects in clinical remission and sustained clinical remission among subjects in clinical response or clinical remission at A3921086 baseline.
    - The median time to relapse among subjects in clinical remission at baseline.
    - CDAI scores over time and change from baseline
    - The proportion of subjects achieving a steroid-free clinical remission at Week 48.
    - Corticosteroid use over time.
    - Serum CRP and fecal calprotectin over time and change from baseline.
    Criterios de valoración de la eficacia
    ?Al tratarse de un estudio de extensión abierto, no habrá criterio de valoración principal de la eficacia. Todos los criterios de valoración de la eficacia serán exploratorios. La remisión clínica mantenida se define como estar en remisión clínica en las semanas 24 y 48.
    ?Proporción de todos los sujetos reclutados que estén en remisión clínica y en remisión clínica mantenida en la semana 48.
    ?Proporción de sujetos en remisión clínica y remisión clínica mantenida entre los pacientes en remisión clínica en el período basal del estudio A3921086.
    ?Proporción de pacientes en remisión clínica y remisión clínica mantenida entre los pacientes con respuesta clínica (respuesta CDAI-100 en el período basal del estudio A3921083) o remisión clínica en el período basal del estudio A3921086.
    ?Mediana del tiempo hasta la recidiva entre los pacientes en remisión clínica en el período basal. La recidiva se define como un incremento del CDAI >100 puntos con respecto al valor basal y una puntuación absoluta del CDAI >220 puntos.
    ?Variación de las puntuaciones CDAI a lo largo del tiempo y de las puntuaciones CDAI desde el período basal.
    ?Proporción de sujetos que logran la remisión clínica sin esteroides en la semana 48 entre los sujetos con esteroides en el período basal.
    ?Uso de corticoides a lo largo del tiempo.
    ?Concentración sérica de PCR y calprotectina fecal a lo largo del tiempo y variación con respecto al valor basal de la PCR y la calprotectina fecal.
    E.5.2.1Timepoint(s) of evaluation of this end point
    All efficacy endpoints are measured at times specified in above section.
    Los tiempos de terminación de todos los criterios de valoración de eficacia se especifican en la siguiente sección
    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 No
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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. 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E. description
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA49
    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
    Czech Republic
    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
    EOT in all participating countries is defined as LSLV. EOT in a member state of the EU is defined as time at which it is deemed that sufficient subjects have been recruited & completed the study as stated in regulatory application (ie, Clinical Study Application) & ethics application in the Member State (MS). Poor recruitment (recruiting less than anticipated number in the CTA) by a MS is not a reason for premature termination but is considered a normal conclusion to the study in that MS
    El final del ensayo(FDE)en los países participantes se define como la última visita del último sujeto.FDE en un Estado miembro de la UE es el momento en que el nºsujetos que han sido incluidos y que han finalizado el estudio es suficiente, según se indica en las solicitudes a las autoridades y al CEIC en el Estado miembro.Un reclutamiento insuficiente no es un motivo de terminación prematura, pero se considera una conclusión normal del estudio en ese estado miembro.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months10
    E.8.9.1In the Member State concerned days12
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months10
    E.8.9.2In all countries concerned by the trial days12
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 12
    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 state6
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    Considering that this is aphase 2b study, there is no plan for CP-690,550 treatment to continue following the end of the A3921086 study subject participation.
    Teniendo en cuenta que este es un estudio fase 2b, no hay ningún plan de tratamiento con CP-690, 550 después de finalizar la participación en el estudio
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-04-13
    P. End of Trial
    P.End of Trial StatusCompleted
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