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    Summary
    EudraCT Number:2013-001368-46
    Sponsor's Protocol Code Number:A3921125
    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:2013-08-08
    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 number2013-001368-46
    A.3Full title of the trial
    A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR.

    Paediatric investigation plan numbers - (P/144/2010),(P/162/2011) and (P/0064/2012).
    ESTUDIO DE FASE III, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, PARA EVALUAR LA EFICACIA Y LA SEGURIDAD DE 2 DOSIS DE TOFACITINIB (CP-690.550) EN PACIENTES CON ARTRITIS PSORIÁSICA ACTIVA Y UNA RESPUESTA INADECUADA AL TRATAMIENTO CON AL MENOS UN INHIBIDOR DEL TNF

    Planes de investigación pediátrica: (P/144/2010),(P/162/2011) y (P/0064/2012).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB (CP-690,550) IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR
    UN ESTUDIO DE LA EFICACIA Y LA SEGURIDAD DE 2 DOSIS DE TOFACITINIB (CP-690.550) EN PACIENTES CON ARTRITIS PSORIÁSICA ACTIVA Y UNA RESPUESTA INADECUADA AL TRATAMIENTO CON AL MENOS UN INHIBIDOR DEL TNF
    A.3.2Name or abbreviated title of the trial where available
    OPAL Beyond
    A.4.1Sponsor's protocol code numberA3921125
    A.7Trial is part of a Paediatric Investigation Plan Yes
    A.8EMA Decision number of Paediatric Investigation PlanP/144/2010
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPfizer Inc., 235 East 42nd Street, New York, NY 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 Centre
    B.5.3 Address:
    B.5.3.1Street Address235 E 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number+18007181021
    B.5.5Fax number+13037391119
    B.5.6E-mailClinicalTrials.gov.CallCenter@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 nameTofacitinib
    D.3.2Product code CP-690,550
    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.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 477600-75-2
    D.3.9.2Current sponsor codeCP-690,550
    D.3.9.3Other descriptive nameCP-690,550-10
    D.3.9.4EV Substance CodeSUB33104
    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 placeboFilm-coated tablet
    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
    Psoriatic arthritis (PsA)
    ARTRITIS PSORIÁSICA (APs)
    E.1.1.1Medical condition in easily understood language
    Psoriatic arthritis is a chronic inflammatory autoimmune disease characterized by joint inflammation, psoriatic skin lesions, enthesitis, dactylitis, spondylitis, and progressive disability.
    APs una enfermedad inflamatoria autoinmune crónica caracterizada por: inflamación de las articulaciones, lesiones psoriásicas en la piel, entesitis, dactilitis, espondilitis, discapacidad progresiva
    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 16.0
    E.1.2Level LLT
    E.1.2Classification code 10037160
    E.1.2Term Psoriatic arthritis
    E.1.2System Organ Class 100000004859
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    1. To compare efficacy of tofacitinib at doses of 5 mg BID and 10 mg BID versus placebo for treatment of rheumatological signs and symptoms of active PsA in subjects who have had an inadequate response in PsA to at least one TNF inhibitor.
    2. To compare physical function status after administration of tofacitinib at doses of 5 mg BID and 10 mg BID versus placebo in subjects with active PsA who have had an inadequate response in PsA to at least one TNF inhibitor.
    3. To compare the safety and tolerability of tofacitinib at doses of 5 mg BID and 10 mg BID versus placebo in subjects with active PsA who have had an inadequate response in PsA to at least one TNF inhibitor.
    1.Comparar la eficacia de tofacitinib a dosis de 5 mg dos veces al día y 10 mg dos veces al día frente a placebo para el tratamiento de los signos y síntomas reumatológicos de la APs activa en pacientes que han presentado una respuesta inadecuada al APs con al menos un inhibidor del TNF.
    2.Comparar el estado de la función física tras la administración de tofacitinib a dosis de 5 mg dos veces al día y 10 mg dos veces al día frente a placebo en pacientes con APs activa que han presentado una respuesta inadecuada en la APs con al menos un inhibidor del TNF.
    3.Comparar la seguridad y tolerabilidad de tofacitinib a dosis de 5 mg dos veces al día y 10 mg dos veces al día frente a placebo en pacientes con APs activa que han presentado una respuesta inadecuada en la APs con al menos un inhibidor del TNF.
    E.2.2Secondary objectives of the trial
    1. To compare the effects of tofacitinib at doses of 5 mg BID and 10 mg BID versus placebo on all health outcomes measures in subjects with active PsA who have had an inadequate response to at least one TNF inhibitor as appropriate for the specific outcome.
    2. To compare the efficacy of tofacitinib at doses of 5 mg BIDand 10 mg BID versus placebo for the treatment of dermatological signs and symptoms of PsA in subjects who have had an inadequate response to at least one TNF inhibitor.
    1.Comparar los efectos de tofacitinib a las dosis de 5 mg dos veces al día y 10 mg dos veces al día frente a placebo sobre las mediciones de las variables de salud en pacientes con APs activa que han mostrado una respuesta inadecuada con al menos un inhibidor del TNF, según corresponda para la variable específica.
    2.Comparar la eficacia de tofacitinib a las dosis de 5 mg dos veces al día y 10 mg dos veces al día frente a placebo en el tratamiento de signos y síntomas dermatológicos de pacientes con APs que han mostrado una respuesta inadecuada con al menos un inhibidor del TNF.
    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. The subject has a diagnosis of PsA based upon the CASPAR (ClASsification criteria for Psoriatic ARthritis) Criteria for at least 6 months and evidence of active arthritis based upon having both ?3 tender/painful joints and ? 3 swollen joints at screening and baseline.
    2. Ongoing treatment with a stable dose of a traditional DMARD (eg, methotrexate, sulfasalazine or leflunomide) (Background DMARDs, as per protocol).
    3. The subject must have active plaque psoriasis at Screening which has been diagnosed or confirmed by a dermatologist or a Sponsor-approved rheumatologist.
    4. PsA Patient Population
    ? Subjects must have received at least one approved TNF inhibiting biologic agent that was administered in accordance with its labeling recommendations and was inadequately effective and/or not tolerated as follows:
    An inadequate response to TNF inhibitor treatment due to lack of efficacy as evident by active PsA at screening, as defined above, and prior treatment according to local label and after minimum treatment duration based upon the agent received:
    ? At least 3 months of adalimumab treatment.
    ? At least 3 months of etanercept treatment.
    ? At least 4 infusions of infliximab.
    ? At least 3 injections of golimumab.
    An inadequate response to TNF inhibitor treatment due to intolerance is defined as a treatment-related adverse event (eg, infusion/injection reactions, infections, laboratory test
    changes, etc).
    5. Subject has discontinued all disallowed concomitant medications for the required time prior to the first dose of study medication and is taking only those concomitant medications in doses and frequency allowed by the protocol.
    Subjects who are receiving any investigational or marketed treatment for PsA or psoriasis not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half lives, whichever is longer. Discontinuation criteria for biologics not otherwise mentioned must be discussed with the Sponsor.
    6. Subjects must not be receiving TNF inhibitors. Subjects on TNF inhibitors must discontinue according to the following criteria:
    ? Etanercept (Enbrel®): Discontinued at least 4 weeks prior to the first dose of study drug;
    ? Adalimumab (Humira®): Discontinued at least 6 weeks prior to first dose of study drug;
    ? Infliximab (Remicade®): Discontinued at least 8 weeks prior to the first dose of study drug;
    ? Golimumab (Simponi®): Discontinued at least 10 weeks prior to the first dose of study drug.
    7. Meet all other eligibility criteria described in the PsA Patient Population, as per Protocol and the Other Inclusion Criteria, as per protocol.

    Please see the Protocol for the full list of inclusion criteria.
    Los pacientes deben cumplir todos los criterios de inclusión siguientes para ser aptos para participar en el estudio:
    1.El paciente presenta un diagnóstico de APs en base a los criterios CASPAR durante un mínimo de 6 meses y evidencia de artritis activa en base a: >= 3 articulaciones sensibles/dolorosas y >=3 articulaciones tumefactas en la selección y en el momento basal.
    2. Tratamiento en curso con una dosis estable de un FARME convencional (p. ej., metotrexato, sulfasalazina o leflunomida) (antecedentes de FARME según protocolo)
    3.El paciente debe presentar psoriasis en placas activa en la selección, la cual ha sido diagnosticada o confirmada por un dermatólogo o un reumatólogo aprobado por el promotor.
    4.Población de pacientes con APs
    ?Los pacientes tienen que haber recibido al menos un agente biológico inhibidor del TNF aprobado que se administró de acuerdo con las recomendaciones del prospecto y resultó poco eficaz y/o no tolerable tal como sigue:
    ?Una respuesta inadecuada al tratamiento con el inhibidor del TNF debido a falta de eficacia evidenciada por la presencia de APs activa en la selección, tal como se define anteriormente, y un tratamiento previo conforme al prospecto local y con una duración mínima de tratamiento que dependerá del agente recibido:
    ?Al menos 3 meses de tratamiento con adalimumab.
    ?Al menos 3 meses de tratamiento con etanercept.
    ?Al menos 4 infusiones de infliximab.
    ?Al menos 3 inyecciones de golimumab.
    ?Una respuesta inadecuada al tratamiento con el inhibidor del TNF debido a intolerancia se define como un acontecimiento adverso relacionado con el tratamiento (p. ej., reacciones a la infusión/inyección, infecciones, cambios en las pruebas en laboratorio, etc.).
    5.El paciente ha suspendido toda la medicación concomitante que no está permitida durante el tiempo requerido antes de la primera dosis de la medicación del estudio y está tomando solo aquella medicación concomitante en la dosis y frecuencia permitidas por el protocolo
    Los pacientes que estén recibiendo algún tratamiento en investigación o comercializado para la APs o la psoriasis, que no se haya mencionado en otra parte, deben haber suspendido el tratamiento durante 4 semanas o 5 semividas, lo que sea más largo. Deben analizarse con el promotor los criterios de interrupción de agentes biológicos que no se mencionen de ninguna otra manera.
    6.Los pacientes no pueden estar recibiendo inhibidores del TNF. Los pacientes que estén siendo tratados con inhibidores del TNF deben interrumpirlos de acuerdo con los siguientes criterios:
    ?Etanercept (Enbrel®): debe interrumpirse al menos 4 semanas antes de la administración de la primera dosis del fármaco del estudio;
    ?Adalimumab (Humira®): debe interrumpirse al menos 6 semanas antes de la administración de la primera dosis del fármaco del estudio;
    ?Infliximab (Remicade®): debe interrumpirse al menos 8 semanas antes de la administración de la primera dosis del fármaco del estudio;
    ?Golimumab (Simponi®): debe interrumpirse al menos 10 semanas antes de la administración de la primera dosis del fármaco del estudio.
    7.Cualquier otro criterio de elegibilidad descrito en la población de PAs según protocolo y de otro Criterio de inclusión según protocolo.
    Para más información ver la sección de criterios de inclusión del protocolo
    E.4Principal exclusion criteria
    Subjects presenting with any of the following will not be included in the study:
    1. Currently have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis, which is allowed.
    2. Pregnant females, breastfeeding females, females of child-bearing potential who are not using highly effective contraception or not agreeing to continue highly effective contraception for at least one ovulatory cycle after last dose of investigational product or females planning pregnancy. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study. (Further description of the requirements and a list of contraceptives considered highly effective and acceptable for use in this study will be found in the Contraceptive Methods in Women of Childbearing Potential section of the protocol).
    3. Blood dyscrasias within 3 months prior to the first dose of study drug including confirmed:
    a. Hemoglobin <10 g/dL (<100 g/L);
    b. White blood cell count <3.0 x 10x9/L (<3000 mm3);
    c. Absolute neutrophil count ?1.5 x 10x9/L (<1500 mm3);
    d. Absolute lymphocyte count of <1.0 x 10x9/L (<1000/mm3);
    e. Platelet count <100 x 10x9/L (<100,000/mm3).
    4. Estimated Creatinine Clearance <40 ml/min based on Cockcroft Gault equation (Appendix 2).
    5. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit.
    6. Current or recent history of uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic (including hypercholesterolemia), endocrine, pulmonary, cardiovascular, or neurologic disease.
    7. History of any autoimmune rheumatic disease other than PsA (including systemic lupus erythematosis, mixed connective tissue disease, scleroderma, polymyositis) or known diagnosis of fibromyalgia, without approval by Sponsor. Also excluded are subjects with prior history of, or current, rheumatic inflammatory disease other than PsA (eg, gout, reactive arthritis, chronic Lyme disease) without approval by Sponsor.
    8. A subject with known immunodeficiency disorder or a first degree relative with a hereditary immunodeficiency.
    9. History of any lymphoproliferative disorder, such as Epstein Barr Virus (EBV) related lymphoproliferative disorder, history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
    10. History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    11. History of infection:
    ? Requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study medication;
    ? Requiring oral antimicrobial therapy within 2 weeks prior to the first dose of study medication.
    12. Any subject who has been vaccinated with live or attenuated vaccines within the 6 weeks prior to the first dose of study medication or is to be vaccinated with these vaccines at any time during treatment or within 6 weeks following discontinuation of study medication. (See Vaccine Guidelines for further information regarding avoidance of household contacts who may be vaccinated, as per protocol).
    13. A subject with any condition possibly affecting oral drug absorption, eg, gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass. Procedures such as gastric banding, that simply divide the stomach into separate chambers, are NOT exclusionary.
    14. History of alcohol or drug abuse unless in full remission for greater than 6 months prior to first dose of study medication.
    15. A subject with a malignancy or with a history of malignancy, with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ.
    16. A subject requiring prohibited concomitant medications.
    17. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus or any chronic infection.
    ? HBsAg+ is exclusionary; subjects who are HBsAg- but HBcAb+ must undergo further testing and be HBsAb+ to be considered for enrollment.
    ? Subjects who are HCVAb+ must undergo further testing for HCV RNA and are allowed to enroll if negative.
    Please see the Protocol for the full list of exclusion criteria.
    Los pacientes que presenten cualquiera de las siguientes características no serán incluidos en el estudio:
    1.Presenta actualmente formas de psoriasis sin placas, como eritrodérmica, en gotas o pustulosa, a excepción de la psoriasis ungueal, que está permitida.
    2.Pacientes que sean miembros del personal del centro de investigación directamente implicados en la realización del ensayo, así como sus familiares, miembros del personal del centro supervisados de alguna otra manera por el investigador o empleados de Pfizer directamente implicados en la realización del ensayo.
    3.Participación en otros estudios de intervención en las 4 semanas previas al inicio del presente estudio y/o durante la participación en el mismo. Participación en cualquier estudio de observación durante la participación en este estudio.
    4.Mujeres embarazadas, mujeres en periodo de lactancia, mujeres en edad fértil que no estén utilizando anticonceptivos de alta eficacia o no estén de acuerdo en seguir utilizando anticonceptivos de alta eficacia durante al menos un ciclo de ovulación tras la última dosis del producto en investigación o mujeres que estén planeando quedarse embarazadas. Las mujeres en edad fértil deben presentar una prueba de embarazo negativa antes de su inclusión en este estudio. (En la sección ?4.6.6 se ofrece una descripción más detallada de los requisitos y una lista de anticonceptivos que se consideran de alta eficacia y aceptables para su uso en este estudio).
    5.Discrasias sanguíneas en los 3 meses anteriores a la primera dosis del fármaco del estudio, incluida la confirmación de:
    a.Hemoglobina < 10 g/dl (< 100 g/l);
    b.Recuento de leucocitos < 3,0 x 109/l (< 3000[/]mm3);
    c.Recuento absoluto de neutrófilos ? 1,5 x 109/l (< 1500[/]mm3);
    d.Recuento absoluto de linfocitos < 1,0 x 109/l (< 1000/mm3);
    e.Recuento de plaquetas < 100 x 109/l (< 100.000/mm3).
    6.Aclaramiento de creatinina estimado < 40 ml/min basado en la ecuación de Cockcroft-Gault (?Apéndice 2).
    7.Bilirrubina total, AST o ALT más de 1,5 veces el límite superior de la normalidad en la visita de selección.
    8.Presencia actual o reciente de enfermedad sin controlar de alguno de estos tipos: renal, hepática, hematológica, gastrointestinal, metabólica (incluida la hipercolesterolemia), endocrina, pulmonar, cardiovascular o neurológica.
    9.Antecedentes de cualquier enfermedad reumática autoinmune distinta a la APs (incluidos lupus eritematoso sistémico, enfermedad mixta del tejido conectivo, esclerodermia, polimiositis) o un diagnóstico conocido de fibromialgia, sin la aprobación del promotor. También se excluyen los pacientes con antecedentes o presencia actual de enfermedad reumática inflamatoria distinta a la APs (p. ej., gota, artritis reactiva, enfermedad de Lyme crónica) sin la aprobación del promotor.
    10.Paciente con una inmunodeficiencia conocida o con un familiar de primer grado con una inmunodeficiencia hereditaria.
    11.Estado funcional en la AR de Clase IV definida según la clasificación del American College of Rheumatology, es decir, con capacidad limitada para llevar a cabo el cuidado personal, actividades profesionales y de ocio.?18
    12.Antecedentes de una prótesis articular infectada en cualquier momento, con la prótesis todavía colocada.
    13.Antecedentes de cualquier trastorno linfoproliferativo, como el síndrome linfoproliferativo asociado al virus de Epstein-Barr (VEB), antecedentes de linfoma, leucemia, o signos y síntomas indicativos de una enfermedad linfática actual.
    14.Antecedentes de herpes zóster recurrente (más de un episodio) o diseminado (un único episodio), o de herpes simple diseminado (un único episodio).
    Para más información ver la sección de criterios de exclusión del protocolo
    E.5 End points
    E.5.1Primary end point(s)
    Primary Endpoints:
    ? ACR (American College of Rheumatology) 20 responder rate at Month 3;
    ? HAQ-DI (Health Assessment Questionnaire-Disability Index) at Month 3.
    Criterios de valoración principales
    ?Tasa de respuesta ACR20 en el Mes 3;
    ?HAQ-DI en el Mes 3.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As above.
    Anteriormente referido
    E.5.2Secondary end point(s)
    Secondary Endpoints:
    Secondary Efficacy Endpoints:
    ? ACR (American College of Rheumatology) 50 and ACR70 responder rates at all timepoints;
    ? ACR20 responder rates at all timepoints other than Month 3;
    ? ACR response criteria components (Health Assessment Questionnaire-Disability Index (HAQ-DI), C-reactive Protein (CRP), Patient?s Assessment of Arthritis Pain, Patient?s Global Assessment of Arthritis, Physician?s Global Assessment of Arthritis, swollen joint count, tender/painful joint count) at Month 3;
    ? Psoriatic Arthritis Response Criteria (PsARC) at Month 1, Month 3 and Month 6;
    ? Physician?s Global Assessment of Psoriasis (PGA-PsO) response at Month 1, Month 3 and Month 6;
    ? Psoriasis Area and Severity Index 75 (PASI75) response at Month 1, Month 3 and Month 6;
    ? Dactylitis severity score at Month 1, Month 3 and Month 6;
    ? Enthesitis score (using the Spondyloarthritis Research Consortium of Canada (SPARCC) enthesitis index and Leeds index) at Month 1, Month 3 and Month 6.

    Secondary Physical Function and Health Outcome Measures:
    Assessed at Months 1, 3 and 6:
    ? Short-Form-36 Health Survey (SF-36) Version 2, Acute;
    ? EuroQol 5-Dimension Health State Profile (EQ-5D);
    ? Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F);
    ? Evaluation of spondylitis using Bath Ankylosing Spondylitis Disease Assessment Index (BASDAI).

    Safety Endpoints:
    Incidence and severity of adverse events.

    Other Endpoints:
    Other Efficacy Endpoints:
    ? ACR response criteria components at (HAQ-DI, CRP, Patient?s Assessment of Arthritis Pain, Patient?s Global Assessment of Arthritis, Physician?s Global Assessment of Arthritis, swollen joint count, tender/painful joint count) at all timepoints except Month 3;
    ? Disease Activity Score (DAS) 28-3(CRP) and at all timepoints;
    ? Psoriatic Arthritis Joint Activity Index (PsAJAI), Psoriatic Arthritis Disease Activity Score (PASDAS), Disease Activity Index for Reactive Arthritis/PsA (DAREA/DAPSA), Composite Psoriasis Disease Activity Index in Psoriatic Arthritis (CPDAI), Minimal Disease Activity (MDA) and their components, at Month 1, Month 3 and Month 6;
    ? PASI and PASI component scores at Month 1, Month 3 and Month 6;
    ? Presence of dactylitis at Month 1, Month 3 and Month 6;
    ? Nail Psoriasis Severity Index (NAPSI) Score at Month 1, Month 3 and Month 6.
    Health Outcome Measures Assessed at Months 1, 3 and 6:
    ? Patient?s Global Joint and Skin Assessment (PGJS-VAS);
    ? Dermatology Life Quality Index (DLQI);
    ? Itch Severity Index (ISI);
    ? Ankylosing Spondylitis Quality of Life (ASQOL) questionnaire.
    Health Outcome Measures Assessed at Months 3 and 6:
    ? PsA Healthcare Resource Utilization Questionnaire (PsA-HCRU);
    ? Work Limitations Questionnaire (WLQ).

    Other Safety Endpoints:
    ? Clinical laboratory tests (eg clinical chemistry, hematology);
    ? Vital sign measurements (blood pressure, pulse rate and temperature);
    ? Physical examinations;
    ? ECG measurements.

    Pharmacokinetic Endpoints:
    ? Oral clearance (CL/F) and other PK parameters calculated from plasma tofacitinib concentrations, if applicable.
    Criterios de valoración secundarios
    Criterios de valoración de la eficacia secundarios
    ?Tasas de respuesta ACR50 y ACR70 en todos los puntos temporales;
    ?Tasas de respuesta ACR20 en todos los puntos temporales distintos al Mes 3;
    ?Componentes de los criterios de respuesta ACR (HAQ-DI, PCR, evaluación del dolor artrítico por el paciente, evaluación global de la artritis por el paciente, evaluación global de la artritis por el médico, recuento de articulaciones tumefactas, recuento de articulaciones sensibles/dolorosas) en el Mes 3;
    ?Criterios de respuesta de la artritis psoriásica (Psoriatic Arthritis Response Criteria, PsARC) en el Mes 1, el Mes 3 y el Mes 6;
    ?Respuesta de la evaluación global de la psoriasis por el médico (PGA-PsO) en el Mes 1, el Mes 3 y el Mes 6;
    ?Respuesta de índice de extensión e intensidad de la psoriasis 75 (PASI75) en el Mes 1, el Mes 3 y el Mes 6;
    ?Puntuación de intensidad de la dactilitis en el Mes 1, el Mes 3 y el Mes 6;
    ?Puntuación de la entesitis (usando el índice de entesitis del Consorcio de investigación de la espondiloartritis de Canadá [SPARCC] y el índice de Leeds) en el Mes 1, el Mes 3 y el Mes 6.
    ?Mediciones de las variables secundarias de función física y salud
    ?Evaluaciones los meses 1, 3 y 6:
    ?Cuestionario de salud en formulario corto de 36 preguntas (SF-36), versión 2, aguda;
    ?Cuestionario del estado de salud en 5 dimensiones EuroQol (EQ-5D);
    ?Evaluación funcional del tratamiento de enfermedades crónicas - Escala de fatiga (FACIT-F);
    ?Evaluación de la espondilitis usando el índice de actividad de Bath para la espondilitis anquilosante (BASDAI).
    Criterios de valoración de la seguridad
    ?Incidencia e intensidad de los acontecimientos adversos.
    Otros criterios de valoración
    Otros criterios de valoración de la eficacia
    ?Los componentes de los criterios de respuesta ACR (HAQ-DI, PCR, evaluación del dolor artrítico por el paciente, evaluación global de la artritis por el paciente, evaluación global de la artritis por el médico, recuento de articulaciones tumefactas, recuento de articulaciones sensibles/dolorosas) en todos los puntos temporales excepto el Mes 3;
    ?DAS28-3(PCR) en todos los puntos temporales;
    ?Índice de actividad articular en la artritis psoriásica (PsAJAI), puntuación de actividad de la enfermedad de artritis psoriásica (PASDAS), índice de actividad de la enfermedad para la artritis reactiva/APs (DAREA/DAPSA), índice compuesto de actividad de la enfermedad de psoriasis en artritis psoriásica (CPDAI), actividad mínima de la enfermedad (MDA) y sus componentes, en el Mes 1, el Mes 3 y el Mes 6;
    ?Puntuaciones PASI y de componentes PASI en el Mes 1, el Mes 3 y el Mes 6;
    ?Presencia de dactilitis en el Mes 1, el Mes 3 y el Mes 6;
    ?Puntuación del índice de intensidad de la psoriasis ungueal (NAPSI) en el Mes 1, el Mes 3 y el Mes 6.
    ?Medidas de las variables de salud evaluadas los meses 1, 3 y 6:
    ?Evaluación global de las articulaciones y la piel por el paciente (PGJS-EVA);
    ?Índice de calidad de vida en dermatología (DLQI);
    ?Índice de intensidad del picor (ISI);
    ?Cuestionario de calidad de vida de la espondilitis anquilosante (CdV-EA).
    ?Medidas de las variables de salud evaluadas los meses 3 y 6:
    ?Cuestionario sobre la utilización de recursos sanitarios de la APs (PsA-HCRU);
    ?Cuestionario de limitaciones laborales (WLQ).
    Otros criterios de valoración de la seguridad
    ?Pruebas clínicas en laboratorio (p. ej. bioquímica, hematología);
    ?Mediciones de las constantes vitales (tensión arterial, frecuencia cardíaca y temperatura);
    ?Exploraciones físicas;
    ?Mediciones de ECG.
    Criterios de valoración de farmacocinética
    ?Aclaramiento oral (CL/F) y otros parámetros FC calculados a partir de la concentración de tofacitinib en plasma, si procede.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As above.
    Anteriormente referido
    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 No
    E.6.11Pharmacogenomic Yes
    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.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 trial4
    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 EEA54
    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
    Belgium
    Brazil
    Canada
    Czech Republic
    France
    Germany
    Mexico
    Poland
    Russian Federation
    Slovakia
    Spain
    Taiwan
    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
    LVLS
    última visita, úlitmo 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 months11
    E.8.9.1In the Member State concerned days4
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months3
    E.8.9.2In all countries concerned by the trial days11
    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: 340
    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 state17
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 159
    F.4.2.2In the whole clinical trial 390
    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)
    None
    Ninguno
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-10-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2016-04-04
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