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    The EU Clinical Trials Register currently displays   42312   clinical trials with a EudraCT protocol, of which   6968   are clinical trials conducted with subjects less than 18 years old.
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    EudraCT Number:2018-003214-41
    Sponsor's Protocol Code Number:CNTO1959PSA3003
    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:2019-01-18
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003214-41
    A.3Full title of the trial
    Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants with Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy
    Ensayo fase 3b, multicéntrico, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y seguridad de guselkumab administrado subcutáneo en pacientes con Artritis Psoriásica activa y con una respuesta inadecuada a la terapia con Factor de necrosis antitumoral alfa (anti-TNFα)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 3 study of Guselkumab in Subjects with Active Psoriatic Arthritis
    Ensayo de fase 3 de Guselkumab en pacientes con Artritis Psoriásica Activa
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCNTO1959PSA3003
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorJanssen-Cilag International N.V.
    B.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 supportJanssen Research & Development, LLC
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen Cilag. S.A.
    B.5.2Functional name of contact pointGlobal Clinical Operations Spain
    B.5.3 Address:
    B.5.3.1Street AddressPaseo de las Doce Estrellas, 5-7
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28042
    B.5.4Telephone number+34917228100
    B.5.5Fax number+34917228628
    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 Yes
    D. name TREMFYA®
    D. of the Marketing Authorisation holderJanssen Cilag International NV
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameGuselkumab
    D.3.2Product code CNTO1959
    D.3.4Pharmaceutical form Solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGuselkumab
    D.3.9.1CAS number 1350289-85-8
    D.3.9.2Current sponsor codeCNTO1959
    D.3.9.4EV Substance CodeSUB179789
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. 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 Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product Yes
    D. medicinal product typeMonoclonal antibody
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection in pre-filled syringe
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Psoriatic Arthritis
    Artritis Psoriásica
    E.1.1.1Medical condition in easily understood language
    Psoriatic Arthritis
    Artritis Psoriásica
    E.1.1.2Therapeutic area Diseases [C] - Musculoskeletal Diseases [C05]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    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
    To evaluate guselkumab efficacy vs placebo in patients with active psoriatic arthritis (PsA) and an inadequate response to anti-TNFα therapy by assessing the reduction in signs and symptoms of joint disease.
    Evaluar la eficacia del guselkumab frente a un placebo en pacientes con artritis psoriásica (APs) activa y una respuesta inadecuada al tratamiento con anti-TNFα mediante la evaluación de la reducción de signos y síntomas de patología articular.
    E.2.2Secondary objectives of the trial
    - Efficacy in improving physical function
    - Efficacy in improving general and disease-specific health-related quality of life and patient-reported health outcomes
    - Efficacy in improving psoriatic skin lesions
    - Safety
    - La eficacia a la hora de mejorar la función física
    - La eficacia a la hora de mejorar la calidad de vida relacionada con la salud tanto general como específica de la enfermedad, así como los resultados relacionados con la salud comunicados por el paciente
    - La eficacia a la hora de mejorar las lesiones cutáneas psoriásicas
    - La seguridad
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Be a man or a woman at least 18 years of age
    2. Have a diagnosis of PsA for at least 6 months before the first administration of study intervention and meet Classification criteria for Psoriatic ARthritis at screening.
    3. Have active PsA as defined by at least 3 swollen joints and at least 3 tender joints at screening and at baseline.
    4. Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis.
    5. Have active plaque psoriasis, with at least one psoriatic plaque of ≥2 cm diameter or nail changes consistent with psoriasis or documented history of plaque psoriasis.
    6. Have an inadequate response to anti-TNFα therapy, defined as presence of active PsA despite previous treatment with either 1 or 2 anti-TNFα agents and either of the following:
    a. Lack of benefit of an anti-TNFα therapy, as documented in the patient history by the treating physician, after at least 12 weeks of etanercept, adalimumab, golimumab, or certolizumab pegol therapy (or biosimilar) and/or at least a 14-week dosage regimen (ie, at least 4 doses) of infliximab (or biosimilar). Documented lack of benefit may include inadequate improvement in joint counts, physical function, or disease activity
    b. Intolerance to an anti-TNFα therapy, as documented in the patient history by the treating physician, to etanercept, adalimumab, golimumab, certolizumab pegol, or infliximab (or biosimilars)

    For a complete overview of the inclusion criteria please refer to protocol section 5.1 (pages 25-29)
    1. Ser un hombre o mujer de al menos 18 años
    2. Haber recibido un diagnóstico de APs durante al menos 6 meses antes de la primera administración de la intervención del estudio y cumplir con los criterios de clasificación para la artritis psoriásica (CASPAR) durante la selección.
    3. Presentar APs activa, que se define como al menos 3 articulaciones inflamadas y al menos 3 articulaciones dolorosas a la palpación durante la selección y en el momento inicial.
    4. Presentar al menos 1 de los subconjuntos de la APs: afectación de las articulaciones interfalángicas distales, artritis poliarticular sin nódulos reumatoides, artritis mutilante, artritis periférica asimétrica o espondilitis con artritis periférica.
    5. Presentar psoriasis activa en placas, con al menos una placa psoriásica de ≥2 cm de diámetro y cambios en las uñas compatibles con psoriasis o antecedentes documentados de psoriasis en placas.
    6. Mostrar una respuesta inadecuada al tratamiento con anti-TNFα, que se define como la presencia de APs activa a pesar del tratamiento anterior con 1 o 2 fármacos anti-TNFα y cualquiera de las siguientes opciones:
    a. Ausencia de beneficio de un tratamiento con anti-TNFα, documentada en el historial clínico del paciente por el médico responsable, tras al
    menos 12 semanas de tratamiento con etanercept, adalimumab, golimumab o certolizumab pegol (o un biosimilar) y/o al menos una pauta posológica de 14 semanas (es decir, al menos 4 dosis) de infliximab (o un biosimilar). Una ausencia de beneficio documentada puede incluir una mejoría inadecuada en los recuentos articulares, la función física o la actividad de la enfermedad.
    b. Intolerancia a un tratamiento con anti-TNFα, documentada en el historial clínico del paciente por el médico responsable, de etanercept, adalimumab, golimumab, certolizumab pegol o infliximab (o biosimilares).

    Para una completa revisión de los criterios de inclusión por favor diríjase a la sección 5.1 del protocolo (páginas 25-29)
    E.4Principal exclusion criteria
    1. Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis, systemic lupus erythematosus, or Lyme disease
    2. Has ever received more than 2 anti-TNFα agents
    3. Has received an anti-TNFα agent (see page 30 of the protocol for a description of the anti-TNFα agents)
    4. Has previously been treated with guselkumab.
    5. Has previously received any biologic treatment, including, but not limited to ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab, or other investigative biologic treatment.

    For a complete overview of the exclusion criteria please refer to protocol section 5.2 (pages 30-33)
    1. Presentar otras patologías inflamatorias que pudieran dificultar la interpretación de las evaluaciones del beneficio del tratamiento con guselkumab, entre las que se incluyen: artritis reumatoide, espondiloartritis axial (sin incluir un diagnóstico principal de artritis psoriásica [APs] con espondilitis), lupus eritematoso sistémico o enfermedad de Lyme.
    2. Haber recibido en algún momento más de 2 fármacos anti-TNFα.
    3. Haber recibido un fármaco anti-TNFα (diríjase a la página 30 del protocolo para una descripción de los agentes anti-TNFα).
    4. Haber recibido con anterioridad un tratamiento con guselkumab.
    5. Haber recibido con anterioridad algún tratamiento biológico (aparte de los fármacos anti-TNFα), incluidos, entre otros: ustekinumab, abatacept, secukinumab, tildrakizumab, ixekizumab, brodalumab, risankizumab u otros tratamientos biológicos en fase de investigación.

    Para una completa revisión de los criterios de exclusión por favor diríjase a la sección 5.2 del protocolo (páginas 30-33)
    E.5 End points
    E.5.1Primary end point(s)
    The Proportion of participants who achieve an American College of Rheumatology (ACR) 20 response
    La proporción de pacientes que logren una respuesta ACR 20 (Colegio de Reumatología de Estados Unidos)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    E.5.2Secondary end point(s)
    1. Change from baseline in Health Assessment Questionnaire-Disability Index score
    2. Proportion of participants who achieve an ACR 50 response
    3. Change from baseline in 36-item short form health survey Physical Component Summary score
    4. Proportion of participants who achieve Psoriatic Area and Severity Index 100 response among participants with ≥3% body surface area psoriatic involvement and an Investigator’s Global Assessment score of ≥2 at baseline
    1. El cambio desde el momento inicial en la puntuación del índice de discapacidad del cuestionario de evaluación de la salud (HAQ-DI)
    2. La proporción de pacientes que logren una respuesta ACR 50
    3. El cambio desde el momento inicial en la puntuación del componente sumario físico (CSF) en un cuestionario de salud de forma corta de 36
    preguntas (SF-36)
    4. La proporción de pacientes que logren una respuesta PASI 100 (índice de gravedad del área de psoriasis) entre pacientes con una afectación
    psoriásica del ≥3% de la superficie corporal y una puntuación IGA (evaluación global del investigador) de ≥2 (leve) en el momento inicial
    E.5.2.1Timepoint(s) of evaluation of this end point
    Week 24
    Semana 24
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    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) 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 No
    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 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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA138
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    Última visita del último paciente
    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 months7
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 221
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 24
    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 state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 245
    F.4.2.2In the whole clinical trial 245
    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)
    There are no plans for additional treatment or care after the subject ends (or has ended) participation in the trial.
    No hay definido un tratamiento o cuidado adicional después de que el paciente termine (o haya terminado) su participación en el ensayo.
    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 Decision2019-02-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-02-12
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-11-11
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