E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic arthritis (PsA) |
Artritis psoriásica (PsA) |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic arthritis (PsA) |
Artritis psoriásica (PsA) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Immune System Diseases [C20] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10037160 |
E.1.2 | Term | Psoriatic arthritis |
E.1.2 | System Organ Class | 100000004859 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the efficacy of guselkumab treatment in participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA. |
Evaluar la eficacia del tratamiento con guselkumab en participantes con artritis psoriásica (psoriatic arthritis, PsA) activa mediante la valoración de la reducción de los signos y síntomas de la PsA. |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the inhibition of progression of structural damage in participants with active PsA. •To evaluate the safety in participants with active PsA. •To evaluate the pharmacokinetics (PK) and immunogenicity in participants with active PsA. |
•Evaluar la inhibición de la progresión del daño estructural en participantes con PsA activa. •Evaluar la seguridad en participantes con PsA activa. •Evaluar la farmacocinética (pharmacokinetics, PK) y la inmunogenia en participantes con PsA activa. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Be at least 18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place). 2.Have active PsA despite previous non-biologic DMARD, apremilast, and/or NSAID therapy. 3.Have a diagnosis of PsA for at least 6 months prior to the first administration of study intervention and meet ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria at screening. 4.Have active PsA as defined by: a.At least three swollen joints and three tender joints at screening and at baseline -AND- b.CRP ≥ 0.3 mg/dL at screening from the central laboratory. NOTE: A one-time repeat assessment of CRP level is allowed during the 6-week screening phase and the investigator may consider the participant eligible if the test result is within acceptable range on repeat testing in the central laboratory. 5.Have ≥2 joints with erosions on baseline radiographs of the hands and feet as determined by central read. 6.Have at least one of the following PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis. 7.Have active plaque psoriasis, with at least one psoriatic plaque of ≥2cm diameter and/or nail changes consistent with psoriasis. 8.If currently using non-biologic DMARDs (limited to MTX, SSZ, HCQ, or LEF), participants should have started treatment at least 3 months and the dose must be stable for at least 4 weeks before first administration of study intervention and should have no serious toxic side effects attributable to the non-biologic DMARD. If currently not using MTX, SSZ, or HCQ, must not have received for at least 4 weeks before first administration of study intervention. If currently not using LEF, must not have received for at least 12 weeks before first administration of study intervention. a.If using MTX, the route of administration and dose must be stable and the dose must be ≤25 mg/week. b.If receiving SSZ, the dose must be ≤3g/day. c.If receiving HCQ, the dose must be ≤400 mg/day. d.If receiving LEF, the dose must be ≤20 mg/day. 9.If using NSAIDs or other analgesics for PsA at baseline, participants must be on a stable dose for at least 2 weeks prior to the first administration of study intervention. If currently not using NSAIDs or other analgesics for PsA, must not have received NSAIDs or other analgesics for PsA within 2 weeks prior to the first administration of study intervention. 10.If using oral corticosteroids at baseline, participants must be on a stable dose equivalent to ≤10 mg of prednisone/day for at least 2 weeks prior to the first administration of study intervention. If not currently using oral corticosteroids, the participant must not have received oral corticosteroids within 2 weeks prior to the first administration of study intervention. |
1.Tener al menos 18 años (o la edad legal de consentimiento en la jurisdicción en la que se realice el estudio). 2.Tener artritis psoriásica (psoriasis arthritis, PsA) activa a pesar de haber recibido tratamiento previo con antirreumáticos modificadores de la enfermedad (disease-modifying antirheumatic drugs, DMARD) no biológicos, apremilast y/o antiinflamatorios no esteroideos (nonsteroidal anti-inflammatory drugs, NSAID). 3.Tener un diagnóstico de PsA desde al menos 6 meses antes de la primera administración de la intervención del estudio y cumplir los criterios de clasificación de la artritis psoriásica (classification criteria for psoriatic arthritis, CASPAR) en la selección. 4.Tener PsA activa, definida por: a.al menos tres articulaciones inflamadas y tres articulaciones dolorosas a la palpación en la selección y en el momento basal y b.proteína C reactiva (C reactive protein, CRP) 0,3 mg/dL en la selección, determinada por el laboratorio central. NOTA: Se permite repetir una vez la determinación de la CRP durante la fase de selección de 6 semanas y el investigador puede considerar que el participante es elegible si el resultado de la prueba repetida en el laboratorio central está dentro del intervalo aceptable. 5.Tener 2 articulaciones con erosiones en las radiografías basales de manos y pies, según la lectura central. 6.Tener al menos uno de los siguientes subconjuntos de la PsA: afectación de la articulación interfalángica distal, artritis poliarticular con ausencia de nódulos reumatoides, artritis periférica asimétrica o espondilitis con artritis periférica. 7.Tener psoriasis en placas activa, con al menos una placa psoriásica de 2 cm de diámetro y/o cambios en las uñas compatibles con psoriasis. 8.Si están utilizando actualmente DMARD no biológicos (limitados a MTX, SSZ, HCQ o LEF), los participantes deben haber iniciado el tratamiento al menos 3 meses y la dosis debe haberse mantenido estable durante al menos 4 semanas antes de la primera administración de la intervención del estudio y no deben tener efectos secundarios tóxicos graves atribuibles al DMARD no biológico. Si actualmente no están utilizando MTX, SSZ o HCQ, no deben haberlos recibido durante al menos 4 semanas antes de la primera administración de la intervención del estudio. Si actualmente no están utilizando LEF, no deben haberlo recibido durante al menos 12 semanas antes de la primera administración de la intervención del estudio. a.Si están utilizando MTX, la vía de administración y la dosis deben ser estables y la dosis debe ser de 25 mg/semana. b.Si están recibiendo SSZ, la dosis debe ser de 3 g/día. c.Si están recibiendo HCQ, la dosis debe ser de 400 mg/día. d.Si están recibiendo LEF, la dosis debe ser de 20 mg/día. 9.Si están utilizando NSAID u otros analgésicos para la PsA en el momento basal, los participantes deben haber estado recibiendo una dosis estable durante al menos 2 semanas antes de la primera administración de la intervención del estudio. Si actualmente no están utilizando NSAID ni otros analgésicos para la PsA, no deben haber recibido NSAID ni otros analgésicos para la PsA en las 2 semanas anteriores a la primera administración de la intervención del estudio. 10.Si están utilizando corticosteroides orales en el momento basal, los participantes deben haber estado con una dosis estable equivalente a 10 mg de prednisona/día durante al menos 2 semanas antes de la primera administración de la intervención del estudio. Si no están utilizando actualmente corticosteroides orales, los participantes no deben haber recibido corticosteroides orales en las 2 semanas anteriores a la primera administración de la intervención del estudio. |
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E.4 | Principal exclusion criteria |
1.Has known allergies, hypersensitivity, or intolerance to study intervention or its excipients. 2.Has other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to RA, axial spondyloarthritis (AS)/non-radiographic axial spondyloarthritis (nr-axSpA), systemic lupus erythematosus, or Lyme disease (confirmed by Western blot). 3.Has the arthritis mutilans subset of PsA. 4.Has previously received any biologic treatment including, but not limited to, guselkumab, ustekinumab, secukinumab, anti-TNFα agents (such as adalimumab, etanercept, infliximab, golimumab SC or intravenous (IV), certolizumab pegol, or their respective biosimilars), tildrakizumab, ixekizumab, brodalumab, risankizumab or other investigative biologic treatment for PsA or psoriasis. 5.Has ever received tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib or any other Janus kinase (JAK) inhibitor. 6.Has received any systemic immunosuppressants (eg, azathioprine, cyclosporine, 6 thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, tacrolimus) within 4 weeks of the first administration of study intervention. 7.Has received non-biologic DMARDs other than MTX, SSZ, HCQ, LEF, within 4 weeks before the first administration of study intervention. 8.Is receiving 3 or more non-biologic DMARDs specified in Table 3 at baseline. Note: participants cannot be on concomitant MTX and LEF. 9.Has received phototherapy or any systemic medications/treatments that could affect psoriasis evaluations (including, but not limited to, retinoids, 1,25-dihydroxy vitamin D3 and analogues, psoralens, fumaric acid derivatives, with the exception of those in Table 3) within 4 weeks of the first administration of study intervention. |
1.Tener alergia, hipersensibilidad o intolerancia conocidas a la intervención del estudio o a sus excipientes. 2.Tener otras enfermedades inflamatorias que podrían confundir las evaluaciones del beneficio de la terapia con guselkumab, como, por ejemplo, artritis reumatoide (rheumatoid arthritis, RA), espondiloartritis axial (axial spondyloarthritis, (AS)/espondiloartritis axial no radiográfica (non-radiographic axial spondyloarthritis, nr-axSpA), lupus eritematoso sistémico o enfermedad de Lyme (confirmado mediante Western blot). 3.Presentar el subconjunto de artritis mutilante de la PsA. 4.Haber recibido previamente algún tratamiento biológico, como guselkumab, ustekinumab, secukinumab, fármacos anti-TNFα (como adalimumab, etanercept, infliximab, golimumab subcutáneo (subcutaneous, SC) o intravenoso (intravenous, IV), certolizumab pegol, o sus respectivos biosimilares), tildrakizumab, ixekizumab, brodalumab, risankizumab u otro tratamiento biológico en investigación para la PsA o la psoriasis. 5.Haber recibido alguna vez tofacitinib, baricitinib, filgotinib, peficitinib, decernotinib, upadacitinib o cualquier otro inhibidor de la cinasa Jano (Janus kinase, JAK). 6. Haber recibido algún inmunosupresor sistémico (por ejemplo, azatioprina, ciclosporina, 6 tioguanina, mercaptopurina, micofenolato mofetil, hidroxiurea, tacrólimus) dentro de las 4 semanas anteriores a la primera administración de la intervención del estudio. 7.Haber recibido DMARD no biológicos distintos de MTX, SSZ, HCQ, LEF, dentro de las 4 semanas anteriores a la primera administración de la intervención del estudio. 8. Estar recibiendo 3 o más DMARD no biológicos especificados en la Tabla 3 en el momento basal. Nota: los participantes no pueden estar en tratamiento concomitante con MTX y LEF. 9.Haber recibido fototerapia o cualquier medicación/tratamiento sistémico que pueda afectar a las evaluaciones de la psoriasis (como, por ejemplo, retinoides, 1,25-dihidroxivitamina D3 y análogos, psoralenos y derivados del ácido fumárico, con la excepción de los de la tabla 3) dentro de las 4 semanas anteriores a la primera administración de la intervención del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
•Proportion of participants with American College of Rheumatology (ACR) 20 response |
•Porcentaje de participantes con una respuesta ACR (American College of Rheumatology) 20 |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
•Change from baseline in PsA modified van der Heijde-Sharp (vdH-S) score •Frequency and type of adverse events (AEs), serious adverse events (SAEs), reasonably related AEs, AEs leading to discontinuation of study intervention, infections, infusion reactions, and injection-site reactions. •Laboratory abnormalities (chemistry, hematology), maximum toxicity (Common Terminology Criteria for Adverse Events [CTCAE 5.0]) grades. •Serum guselkumab concentration. •Incidence of antibodies to guselkumab. |
•Variación respecto al momento basal de la puntuación vdH-S (van der Heijde-Sharp) modificada de PsA •Frecuencia y tipo de acontecimientos adversos (adverse events, AE), acontecimientos adversos graves (serious adverse events, SAE), AE que lleven a la suspensión del tratamiento del estudio, infecciones, reacciones a la infusión y reacciones en el punto de inyección. •Anomalías de laboratorio (bioquímica, hematología), con grados de toxicidad máxima según los Criterios terminológicos comunes para acontecimientos adversos (Common Terminology Criteria for Adverse Events, CTCAE), versión 5.0. •Concentración sérica de guselkumab •Incidencia de anticuerpos contra el guselkumab. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Week 24 and visit over time through week 156 or 168 |
Semana 24 y por visita a lo largo del tiempo hasta la semana 156 o 168 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
immunogenicity |
Inmunogenia |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 134 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Belarus |
Bosnia and Herzegovina |
Canada |
Georgia |
Israel |
Philippines |
Russian Federation |
Serbia |
Taiwan |
Ukraine |
United States |
Bulgaria |
Croatia |
Estonia |
Germany |
Hungary |
Italy |
Latvia |
Lithuania |
Poland |
Slovakia |
Slovenia |
Spain |
Czechia |
Greece |
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E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 26 |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 5 |