E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Psoriatic Arthritis |
Artritis Psoriásica |
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E.1.1.1 | Medical condition in easily understood language |
Psoriatic Arthritis |
Artritis Psoriásica |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
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 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. |
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E.2.2 | Secondary 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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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) |
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E.4 | Principal 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) |
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E.5 End points |
E.5.1 | Primary 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) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary 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 |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
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 | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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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 | 2 |
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 | 17 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 138 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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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LVLS |
Última visita del último paciente |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |