Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   43801   clinical trials with a EudraCT protocol, of which   7272   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).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2011-005689-39
    Sponsor's Protocol Code Number:A3921119
    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:2013-06-24
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-005689-39
    A.3Full title of the trial
    A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED,
    DOSE-RANGING STUDY OF THE EFFICACY AND SAFETY OF TOFACITINIB IN SUBJECTS WITH ACTIVE ANKYLOSING SPONDYLITIS (AS)
    ESTUDIO DE FASE II, ALEATORIZADO, DOBLE CIEGO, CONTROLADO CON PLACEBO, DE BÚSQUEDA DE LA DOSIS, SOBRE LA EFICACIA Y SEGURIDAD DE TOFACITINIB EN PACIENTES CON ESPONDILITIS ANQUILOSANTE (EA) ACTIVA
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A clinical study to evaluate the effects and safety of three doses of Tofacitinib (a drug that is being investigated for the treatment of rheumatoid arthritis) in subjects with active Ankylosing spondylitis (AS) (a form of Arthritis)
    Estudio para evaluar los efectos y seguridad de tres dosis de Tofacintinib (medicamento que se está siendo investigador para el tratamiento de artritis reumatoide) en pacientes con espondilitis anquilosante (EA) (un tipo de artitis).
    A.4.1Sponsor's protocol code numberA3921119
    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, 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 AddressEast 42nd Street
    B.5.3.2Town/ cityNew York
    B.5.3.3Post codeNY 10017
    B.5.3.4CountryUnited States
    B.5.4Telephone number001 800 7181021
    B.5.5Fax number001 303 739 1119
    B.5.6E-mailClinicalTrials.govCallCentrere@pfizer.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCP-690,550-10
    D.3.2Product code CP-690,550-10
    D.3.4Pharmaceutical form 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 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    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.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-690,550-10
    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.3.8INN - Proposed INNTofacitinib
    D.3.9.1CAS number 540737-29-9
    D.3.9.2Current sponsor codeCP-690,550-10
    D.3.9.3Other descriptive nameTOFACITINIB CITRATE
    D.3.9.4EV Substance CodeSUB33105
    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) 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
    D.8 Placebo: 2
    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
    Ankylosing Spondylitis (AS)
    Espondilitis Anquilosante (EA)
    E.1.1.1Medical condition in easily understood language
    a type of inflammatory arthritis that affects parts of the spine, including the bones, muscles and ligaments
    Un tipo de artritis que afecta partes de la columna vertebral, incluyendo
    los huesos, músculos y ligamentos.
    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 PT
    E.1.2Classification code 10002556
    E.1.2Term Ankylosing spondylitis
    E.1.2System Organ Class 10028395 - Musculoskeletal and connective tissue disorders
    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 the efficacy of tofacitinib, in doses of 2 mg BID, 5 mg BID, 10 mg BID versus placebo on the ASAS20 response rate at Week 12 in subjects with active AS that have had an inadequate response to previous treatment.
    2. To estimate the placebo-corrected dose response for the ASAS20 at Week 12 in subjects with active AS that have had an inadequate responst to previous treatment.
    3. To compare the safety of tofacitinib at all doses versus placebo in all study subjects.
    1.Comparar la eficacia de tofacitinib, en dosis de 2 mg, 5 mg y 10 mg dos veces al día (BID) frente a placebo, en la tasa de respuesta ASAS20 en la semana 12 en pacientes con EA activa, que han presentado una respuesta inadecuada al tratamiento previo.
    2.Estimar la respuesta a la dosis corregida con placebo para el ASAS20 en la semana 12 en pacientes con EA activa, que han presentado una respuesta inadecuada al tratamiento previo.
    3.Comparar la seguridad de tofacitinib en todas las dosis frente a placebo en todos los pacientes del estudio.
    E.2.2Secondary objectives of the trial
    None
    Ninguno
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspects of the study.
    2. Subjects who are willing and able to comply with scheduled visits, treatment plan,laboratory tests, and other study procedures.
    3. Subject is at least 18 years old (20 years old for subjects in Taiwan) at the Screening Visit.
    4. The subject has a diagnosis of AS based on the Modified New York Criteria for Ankylosing Spondylitis (1984).
    5. Subject has active AS at the Screening and Baseline (Day 1) visits defined as:
    ? BASDAI score of >=4; and
    ? Back pain score (BASDAI Question 2) of >=4.
    6. Subject has active disease despite nonsteroidal anti-inflammatory drug (NSAID) therapy or is intolerant to NSAIDs as defined by either:
    - Subject must have had an adequate trial of at least 2 different oral NSAIDs taken over a total period of 4 weeks.
    or
    - Intelerance to NSAID therapy. Intolerance is defined as the subject must have discontinued NSAID treatment due to a related adverse event (eg, allergic reaction, gastrointestinal symptoms or signs, hypertension, etc).

    7. Subjects may be receiving the following non-biologic DMARDs at the time of the Screening visit. These medications should be continued throughout the entire study and doses should remain unchanged. Any other DMARDs require discussion prior to enrollment with the sponsor for washout timeframe.
    ? Methotrexate: Maximum dose of 20 mg/week. Minimum duration of therapy 4 months and dose stable for 4 weeks prior to first dose of study drug. Subjects on methotrexate should be on an adequate and stable dose of folate supplementation (eg, not less than 5 mg weekly based on folic acid, unless such doses would violate the local label guidelines or standard of care) for at least 4 weeks prior to the first dose of study drug. Subject must not have had previous serious toxicity while on
    methotrexate and not be expected to require evaluation for possible methotrexate toxicity (eg, require a liver biopsy for methotrexate toxicity) during the study; ? Sulfasalazine (Azulfidine, Salazpyrin): Maximum dose of 3 gm/day. Minimum duration of therapy 2 months and dose stable for 4 weeks prior to first dose of study drug.
    8. Subjects who are already taking oral corticosteroids (not injectables) may participate in the study:
    ? Oral corticosteroids: Subjects who are already receiving oral corticosteroids must be
    on a stable dose of =<10 mg/day of prednisone or equivalent for 4 weeks prior to the first dose of study medication;
    ? Injected (eg, intraarticular, intramuscular, epidural or intravenous) corticosteroids
    must be discontinued 4 weeks prior to the first dose of study medication;
    ? Topical and intra-rectal corticosteroids will be allowed during the study.
    9. Subject has discontinued all disallowed concomitant medication 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.
    10. Subjects who are receiving any investigational or marketed treatment for AS, arthritis or back pain not mentioned elsewhere must have that treatment discontinued for 4 weeks or 5 half-lives, whichever is longer.
    11. Subjects receiving non-prohibited concomitant medications for any reason must be willing to stay on a stable regimen as defined in the protocol.
    12. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) as defined in protocol.
    13. Women of childbearing potential must test negative for pregnancy prior to enrollment in this study.
    15. Female subjects who are not of childbearing potential (ie, meet at least one of the following criteria): ? Have undergone hysterectomy or bilateral oophorectomy; ? Have medically confirmed ovarian failure; ? Are medically confirmed to be post-menopausal (cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause); laboratory confirmation of FSH level indicative of post menopausal according to the central laboratory may be indicated per investigator?s determination.
    1.Prueba de un documento de consentimiento informado, firmado y fechado personalmente, que indique que se ha informado al paciente (o a su representante legal) de todos los aspectos pertinentes del estudio.
    2.Los pacientes deben estar dispuestos a y ser capaces de cumplir las visitas programadas, el plan de tratamiento, las pruebas analíticas y otros procedimientos del estudio.
    3.El paciente tiene, al menos, 18 años de edad (20 años para los pacientes de Taiwán) en la visita de selección.
    4.El paciente tiene un diagnóstico de EA basado en los criterios modificados de Nueva York para la espondilitis anquilosante (1984). Consulte el ?Apéndice 2.
    5.El paciente presenta una EA activa en las visitas de selección y de línea basal (día 1) definida como:
    ?puntuación BASDAI de >= 4; y puntuación del dolor de espalda (pregunta 2 de BASDAI) de >= 4.
    6.El paciente presenta una enfermedad activa a pesar del tratamiento con antiinflamatorios no esteroideos (AINE) o es intolerante a los AINE, lo que se define como: el paciente debe haber tenido un ensayo adecuado de al menos 2 AINE orales diferentes tomados en un periodo total de 4 semanas; O intolerancia al tratamiento con AINE. La intolerancia se define como que el paciente debe haber interrumpido el tratamiento con AINE debido a un acontecimiento adverso relacionado (p. ej., reacción alérgica, signos o síntomas gastrointestinales, hipertensión, etc.).
    7.Los pacientes pueden estar recibiendo los siguientes FARME no biológicos en el momento de la visita de selección. Deben mantenerse estas medicaciones durante todo el estudio y las dosis deben permanecer invariables. Cualquier otro FARME requiere una discusión con el promotor antes de la inclusión para el periodo de lavado.
    ?Metotrexato: Dosis máxima de 20 mg/semana. Duración mínima de la terapia de 4 meses y una dosis estable durante 4 semanas antes de la primera dosis del fármaco del estudio. Los pacientes que tomen metotrexato deben recibir una dosis adecuada y estable de un suplemento de folatos (p.ej., no menos de 5 mg semanales basado en el ácido fólico, a menos que dichas dosis infrinjan las directrices del prospecto local o el tratamiento estándar) durante al menos 4 semanas antes de la primera dosis del fármaco del estudio. Los pacientes no pueden haber presentado una toxicidad grave anterior mientras recibían metotrexato y no debe esperarse que se requiera una evaluación por una posible toxicidad por metotrexato (p. ej., necesidad de una biopsia de hígado por toxicidad con metotrexato) durante el estudio;
    ?Sulfasalazina (Azulfidine, Salazopyrina): Dosis máxima de 3 mg/día. Duración mínima de la terapia de 2 meses y una dosis estable durante 4 semanas antes de la primera dosis del fármaco del estudio.
    8.Los pacientes que ya estén tomando corticoesteroides orales (no inyectables) pueden participar en el estudio:
    ?Corticoesteroides orales: Los pacientes que ya estén recibiendo corticoesteroides orales deben recibir una dosis estable de <=10 mg/día de prednisona o un equivalente durante 4 semanas antes de la primera dosis de la medicación del estudio; ?Debe suspenderse el uso de corticoesteroides inyectables (p.ej. intraarticular, intramuscular, epidural o intravenoso) 4 semanas antes de la primera dosis de la medicación del estudio; ? Los corticoesteroides tópicos e intrarrectales estarán permitidos durante el estudio.
    9. El paciente ha suspendido toda la medicación concomitante que no está permitida durante el tiempo requerido antes de la primera dosis de la medicación de estudio y está tomando sólo aquella medicación concomitante en la dosis y frecuencia permitidas por el protocolo.
    10. Los pacientes que estén recibiendo algún tratamiento en investigación o comercializado para la AE, la artritis o el dolor de espalda, que no se haya mencionado en otra parte, deben suspender el tratamiento durante 4 semanas o 5 vidas medias, lo que sea más largo.
    11. Los pacientes que reciban una medicación concomitante no prohibida, por cualquier motivo, deben estar dispuestos a continuar con una pauta estable, tal y como se define en el protocolo.
    (para más información ver páginas 29 a la 31 del protocolo)
    E.4Principal exclusion criteria
    1. 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.
    2. Participation in other interventional studies within 4 weeks before the current study begins and/or during study participation (excluding noninterventional follow-up during the screening period).
    3. Subjects receiving any other DMARDs (other than those allowed), thalidomide (including previous use).
    4. Subjects currently receiving or previous use of a TNF inhibitor or other biological agent.
    5. Blood dyscrasias at screening or within 3 months prior to the first dose of study drug including confirmed:
    a. Hemoglobin <10 g/dL;
    b. Absolute white blood cell count (WBC) <3.0 x 10 9/L (<3000 mm3);
    c. Absolute neutrophil count (ANC) <1.2 x 10 9/L (<1200 mm3);
    d. Absolute lymphocyte count <1.0 x 10 9/L (<1000/mm3);
    e. Platelet count <100 x 10 9/L (<100,000/mm3).
    One re-testing of laboratory-acceptable specimen (eg, appropriately labeled within stability parameters, not hemolyzed, appripriate typr (tube and reagent) and volume) is allowed of any above parameters if the abnormal lab(s) was an uncharacteristic result(s). Documentation in the source of the typical results to allow a repeat lab is required.
    Re-test must be completed within the screening period.
    6. Estimated Creatinine Clearance <40 mL/min based on Cockcroft Gault equation at Screening visit.
    7. Total bilirubin, AST or ALT more than 1.5 times the upper limit of normal at screening visit. (One re-testing with an uncompromised sample is allowed if the abnormal lab result was an uncharacteristic result and must be completed within the screening period. Documentation in the source of the typical results to allow a repeat lab is required).
    8. History of any other autoimmune rheumatic disease (eg, systemic lupus erythematosis (SLE), mixed connective tissue disease (MCTD), scleroderma, polymositis) or known diagnosis of fibromyalgia, without approval by Sponsor.
    9. History of an infected joint prosthesis at any time, with the prosthesis still in situ.
    10. History of any lymphoproliferative disorder, such as Epstein Barr Virus related
    lymphoproliferative disorder (EBV-LPD), history of lymphoma, leukemia, or signs and symptoms suggestive of current lymphatic disease.
    11. History of recurrent (more than one episode) herpes zoster or disseminated/multi-dermatomal (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.
    12. 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.
    13. History of infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study medication.
    14. Any prior treatment with alkylating agents (eg, cyclophosphamide or chlorambucil), total lymphoid irradiation, etc. 15. 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 vaccinate with these vaccines at any time during treatment or within 6 weeks after last dose of study drug.
    16. 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. 17. History of alcohol or drug abuse unless in full remission for greater than 6 months prior to first dose of study medication.
    18. Body weight or body habitus greater than what can be accommodated by the site?s MRI scanner table weight limits or MRI scanner bore.
    19. Any contraindication to MRI that in the judgment of the investigator and MRI center poses a safety risk to the subject such as, but not limited to, cardiac pacemaker; implanted cardiac defibrillator; aneurysm clips; carotid artery vascular clamp; neurostimulator; insulin or infusion pumps; bone growth/fusion stimulator; cochlear, otologic, and ear implants.
    20. Subjects with passive implants that may be weakly ferromagnetic in the vicinity of the RF coil that may cause image artifacts in the spine and SI joints.
    For exclusion criteria 21-30 see protocol.
    1.Los pacientes que sean miembros del personal del centro de investigación, los parientes de los miembros del personal del centro o los pacientes que sean empleados de Pfizer directamente implicados en la realización del ensayo.
    2.La participación en otros estudios de intervención en las 4 semanas previas al inicio del presente estudio y/o durante la participación en el mismo (excluido el seguimiento de no intervención durante el período de selección).
    3.Los pacientes que reciben otros FARME (distintos a los permitidos), talidomida (incluido el uso previo) y otra medicación concomitante prohibida, como se indica en el ?Apéndice 4.
    4.Los pacientes que están recibiendo actualmente o han recibido previamente algún inhibidor de FNT u otro agente biológico.
    5.Discrasias sanguíneas en la selección o en los 3 meses anteriores a la primera dosis del fármaco del estudio, incluida la confirmación de:
    a.Hemoglobina < 10 g/dl; b.Recuento absoluto de leucocitos (RAL) < 3,0 x 109/l (< 3000/mm3); c. Recuento absoluto de neutrófilos (RAN) < 1,2 x 109/l (< 1200/mm3); d. Recuento absoluto de linfocitos < 1,0 x 109/l (< 1000/mm3); e. Recuento de plaquetas < 100 x 109/l (< 100.000/mm3).
    Se permite una repetición del análisis en una muestra aceptable por el laboratorio (p. ej., etiquetada correctamente, dentro de los parámetros de estabilidad, no hemolizada, de tipo [tubo y reactivo] y volumen adecuados) de cualquiera de los parámetros anteriores si los resultados analíticos anómalos fueron unos resultados inusuales. Se requiere la documentación en el archivo original de los resultados típicos para permitir que se repita el análisis. La repetición del análisis debe completarse dentro del periodo de selección.
    6. Aclaramiento de creatinina estimado < 40 ml/min basado en la ecuación de Cockcroft Gault en la visita de selección.
    7. Bilirrubina total, AST o ALT más de 1,5 veces el límite superior de la normalidad en la visita de selección. (Está permitida una repetición del análisis con una muestra no comprometida si el resultado analítico anómalo fue inusual y debe completarse dentro del periodo de selección. Se requiere la documentación en el archivo original de los resultados típicos para permitir que el análisis se repita).
    8. Antecedentes de cualquier otra enfermedad reumática autoinmune (p. ej., lupus eritematoso sistémico [LES], enfermedad mixta del tejido conectivo [EMTC], esclerodermia, polimiositis) o un diagnóstico conocido de fibromialgia, sin la aprobación del promotor.
    9. Antecedentes de una prótesis articular infectada en cualquier momento, con la prótesis todavía colocada.
    10. Antecedentes de cualquier trastorno linfoproliferativo, como el síndrome linfoproliferativo asociado al virus de Epstein-Barr (SLP-VEB), antecedentes de linfoma, leucemia, o signos y síntomas indicativos de una enfermedad linfática actual.
    11. Antecedentes de herpes zóster recurrente (más de un episodio) o diseminado/multidermatomérico (un único episodio), o de herpes simple diseminado (un único episodio).
    12. Antecedentes de infección con necesidad de hospitalización o de antibióticos parenterales, o considerada clínicamente significativa por el investigador, en los 6 meses anteriores a la primera dosis de la medicación del estudio.
    13. Antecedentes de infección que haya requerido un tratamiento con antibióticos en las 2 semanas anteriores a la primera dosis de la medicación del estudio.
    14. Cualquier tratamiento previo con agentes alquilantes (p. ej., ciclofosfamida o clorambucilo), irradiación linfoide total, etc.
    15. Cualquier paciente que haya sido vacunado con organismos vivos o atenuados en las 6 semanas anteriores a la primera dosis de la medicación del estudio, o deba ser vacunado con dichas vacunas en cualquier momento durante el tratamiento o en las 6 semanas posteriores a la última dosis del fármaco del estudio.
    16. Un paciente con cualquier trastorno que pueda afectar a la absorción oral de los fármacos, como, por ejemplo, gastrectomía, gastroenteropatía diabética clínicamente significativa o determinados tipos de cirugía bariátrica, como la derivación gástrica. Los procedimientos tales como la colocación de bandas gástricas, que simplemente dividen el estómago en porciones independientes, NO son motivo de exclusión.
    17. Antecedentes de alcoholismo o toxicomanía, salvo que el paciente lleve en remisión completa más de 6 meses antes de la primera dosis del fármaco del estudio.
    18. Peso corporal o complexión corporal mayor de lo que permiten las limitaciones de peso de la mesa del aparato de RM del centro o del diámetro del aparato de RM.
    (para más información ver las páginas 32 a la 34 del protocolo)
    E.5 End points
    E.5.1Primary end point(s)
    - ASAS 20 response rate
    Tasa de respuesta ASAS20
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 12
    Semana 12
    E.5.2Secondary end point(s)
    A validated endpoint such as Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Index of Disease Activity Score and/or modified Berlin Ankylosing Spondylitis Spine Magnetic Resonance Imaging Activity Score (ASspiMRI) of the SI joints and spine at Week 12.
    ?ASAS20 response at all other time points.
    ?ASAS40 response at all time points.
    ?ASAS 5/6 response at all time points.
    ?Ankylosing Spondylitis Disease Activity Score using C-Reactive Protein
    (ASDASCRP) at all time points.
    ?ASDAS clinically important improvement, ASDAS major improvement and ASDAS inactive disease at all time points.
    ?Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at all time points.
    ?BASDAI50 response at all time points.
    ?Bath Ankylosing Spondylitis Functional Index (BASFI) at all time points.
    ?Bath Ankylosing Spondylitis Metrology Index (BASMI) at all time points.
    ?Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at all time points collected.
    ?Extra-articular Involvement (Specific Medical History and peripheral articular involvement [as assessed by swollen joint count]) at all time points collected.
    ?Spinal mobility at all time points collected.
    ?Un criterio de valoración validado, tal como el índice de puntuación de actividad de la enfermedad del Consorcio de investigación de la espondiloartritis de Canadá (Spondyloarthritis Research Consortium of Canada, SPARCC) mediante resonancia magnética (RM) y/o el índice de actividad de la espondilitis anquilosante mediante resonancia magnética de la columna (Ankylosing Spondylitis Spine Magnetic Resonance Imaging, ASspiMRI) modificado de Berlín de las articulaciones sacroilíacas y la columna vertebral en la semana 12.
    ?Respuesta ASAS20 en todos los otros puntos temporales.
    ?Respuesta ASAS40 en todos los puntos temporales.
    ?Respuesta ASAS 5/6 en todos los puntos temporales.
    ?Puntuación de actividad de la enfermedad de la espondilitis anquilosante mediante la proteína C reactiva (Ankylosing Spondylitis Disease Activity Score using C-Reactive Protein, ASDASCRP) en todos los puntos temporales.
    ?Mejoría de relevancia clínica según ASDAS, mejoría considerable según ASDAS y enfermedad inactiva según ASDAS, en todos los puntos temporales.
    ?Indice de actividad de Bath para la espondilitis anquilosante (BASDAI) en todos los puntos temporales.
    ?Respuesta BASDAI50 en todos los puntos temporales.
    ?Índice funcional de Bath para la espondilitis anquilosante (BASFI) en todos los puntos temporales.
    ?Índice de metrología de Bath para la espondilitis anquilosante (BASMI) en todos los puntos temporales.
    ?Puntuación de Maastricht de entesitis en la espondilitis anquilosante (Maastricht Ankylosing Spondylitis Enthesitis Score, MASES) en todos los puntos temporales recopilados.
    ?Afectación extraarticular (historia clínica específica y afectación articular periférica [medida mediante el recuento de articulaciones tumefactas]) en todos los puntos temporales recopilados.
    ?Movilidad espinal en todos los puntos temporales recopilados.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 2, 4, 8, 12
    Semanas 2, 4, 8, 12
    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 Yes
    E.6.12Pharmacoeconomic Yes
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    patient reported outcomes
    resultados notificados por el paciente
    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.8.2.4Number 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    Canada
    Czech Republic
    Germany
    Hungary
    Korea, Republic of
    Poland
    Russian Federation
    Spain
    Taiwan
    United States
    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
    LVLS
    última visita del último paciente (UVUP)
    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 months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    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) No
    F.1.2.1Number of subjects for this age range: 190
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state22
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 108
    F.4.2.2In the whole clinical trial 200
    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)
    No special measures; subjects may be treated as per standard local practice outside the scope of the clinical trial
    No hay medidas especiales; los pacientes deben ser tratados con los procedimientos habituales fuera del objetivo del estudio.
    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 Decision2013-06-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-06-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-03-18
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA