E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Active Psoriatic Arthritis |
Artritis psoriásica activa |
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E.1.1.1 | Medical condition in easily understood language |
Active Psoriatic Arthritis |
Artritis psoriásica activa |
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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 | 17.1 |
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 in subjects with active PsA by assessing the reduction in signs and symptoms of PsA. - To assess the safety and tolerability of guselkumab in subjects with active PsA. |
-Evaluar la eficacia de guselkumab en pacientes con Artritis Psoriásica APs activa valorando la reducción de signos y síntomas de APs. -Evaluar la seguridad y tolerabilidad de guselkumab en pacientes con Artritis Psoriásica APs activa. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are: - To evaluate the efficacy of guselkumab in improving physical function. - To evaluate the impact of guselkumab on quality of life. - To evaluate the efficacy of guselkumab on psoriatic skin lesions. - To evaluate the PK and immunogenicity of guselkumab in subjects with active PsA. - To evaluate the PD characteristics of guselkumab with and without MTX in subjects with active PsA. - To evaluate the efficacy and safety of guselkumab following 1 year of exposure.
The exploratory objectives are: - To evaluate the correlation between PK and PD characteristics of guselkumab in subjects with PsA. - To use ultrasound to evaluate the changes in musculoskeletal abnormalities (enthesitis, tenosynovitis, and synovitis) from baseline in patients with active PsA treated with guselkumab as compared to placebo) |
-Evaluar la eficacia de guselkumab para mejorar la función física. -Evaluar cómo afecta guselkumab a la calidad de vida. -Evaluar la eficacia de guselkumab en lesiones cutáneas psoriásicas. -Evaluar la FC e inmunogenicidad de guselkumab en pacientes con APs activa. -Evaluar las características FD de guselkumab con y sin MTX en pacientes con APs activa. -Evaluar la eficacia y seguridad de guselkumab tras un periodo de exposición de 1 año. Los objetivos exploratorios son: -Evaluar la correlación entre las características FC y FD de guselkumab en pacientes con APs activa. -Emplear exploraciones ecográficas para evaluar las variaciones en las alteraciones osteomusculares (entesitis, tenosinovitis y sinovitis) con respecto al valor basal en pacientes con APs activa tratada con guselkumab en comparación con placebo. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Substudies in CNTO1959PSA2001: A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Guselkumab in the Treatment of Subjects with Active Psoriatic Arthritis - In selected sites, an ultrasound substudy will be conducted to explore the use of ultrasound for the assessment of PsA musculoskeletal abnormalities (enthesitis, tenosynovitis and synovitis). - Subjects who consent to participate in the fecal microbiome substudy will be asked to provide stool samples. The objective of the fecal microbiome substudy is to assess whether bacterial species, products of bacteriel species, and products of host-bacterial interactions are associated with PsA or response to guselkumab. Amendment 1; 5 February 2015 |
Subestudio en CNTO1959PSA2001: Ensayo en fase 2a, aleatorizado, doble ciego, controlado con placebo para evaluar la eficacia y la seguridad de guselkumab en el tratamiento de pacientes con artritis psoriásica activa - En determinados centros, se realizará un subestudio ecográfico con el fin de explorar el uso de la ecografía para la evaluación de las alteraciones osteomusculares de la APs (entesitis, tenosinovitis y sinovitis). - Los pacientes que consientan en participar en el subestudio del microbioma fecal se les preguntará si proporcionarán las muestras de heces.El objetivo de la subestudio microbioma fecal es evaluar si las especies bacterianas, productos de especies bacterianas, y los productos de las interacciones huésped-bacteriana se asocian con PSA o la respuesta a guselkumab. Enmienda 1; 5 Febrero 2015 |
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E.3 | Principal inclusion criteria |
- Has had Psoriatic Arthritis (PsA) for at least 6 months before the first administration of study drug and meet classification criteria for Psoriatic Arthritis (CASPAR) at Screening - Had active PsA as defined by: a. At least 3 swollen joints and at least 3 tender joints at Screening and at baseline b. C-reactive protein (CRP) greater than or equal to (>=) 0.3 milligram (mg)/deciliter (dL) at Screening from the central laboratory - Has 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 - Has plaque psoriasis with body surface area (BSA) involvement greater than or equal to (>=) 3% at Screening and baseline - Has active PsA despite current or previous non-biologic diseasemodifying antirheumatic drugs (DMARD), oral corticosteroid, and/or nonsteroidal anti-inflammatory drug (NSAID) therapy - If using methotrexate (MTX), oral corticosteroids or NSAIDs, the dose must be stable |
-Haber sufrido APs durante al menos 6 meses antes de la administración de la primera dosis del fármaco del estudio y cumplir los criterios de clasificación para la artritis psoriásica (CASPAR) en la visita selección. -Padecer APs activa según la siguiente definición: a) 3 o más articulaciones hinchadas y 3 o más articulaciones dolorosas a la palpación en la selección y el período basal b)Proteína C reactiva (PCR)(>=) 0,3 mg/dl en la visita de selección desde el laboratorio central. -Pertenecer al menos a 1 de los subgrupos de APs: afectación de las articulaciones interfalángicas distales, artritis poliarticular con ausencia de nódulos reumatoides, artritis mutilante, artritis periférica asimétrica o espondilitis con artritis periférica. -Tener psoriasis en placa con una afectación de (>=) 3 % de la superficie corporal (SC) en la selección y el período basal. -Padecer APs activa a pesar del tratamiento actual o previo con FARME no biológicos, corticoides orales y/o AINE -En caso de utilizar MTX, corticoides orales o AINES La dosis deberá ser estable |
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E.4 | Principal exclusion criteria |
- Have other inflammatory diseases that might confound the evaluations of benefit of guselkumab therapy, including but not limited to rheumatoid arthritis (RA), ankylosing spondylitis (AS), systemic lupus erythematosus, or Lyme disease - Has previously received guselkumab or ustekinumab - Has received more than 1 type of biologic anti-tumor necrosis factor (TNF) agent previously - Have received infliximab (or its biosimilars) or golimumab intraveneous (IV) within 12 weeks before the first administration of study drug - Have received adalimumab (or its biosimilars), golimumab subcutaneous (SC), certolizumab pegol or etanercept (or its biosimilars) within 8 weeks before the first administration of study drug |
-Padecer otras enfermedades inflamatorias que puedan confundir las evaluaciones de los efectos beneficiosos del tratamiento con guselkumab, como por ejemplo AR, EA, lupus eritematoso sistémico o enfermedad de Lyme. -Haber recibido tratamiento previo con guselkumab o ustekinumab. -Haber recibido previamente más de un tipo de fármaco anti-TNF biológico. -Haber recibido infliximab (o sus biosimilares) o golimumab por vía iv en el plazo de 12 semanas antes de la administración de la primera dosis del fármaco del estudio. -Haber recibido adalimumab (o sus biosimilares), golimumab por vía sc, certolizumab pegol o etanercept (o sus biosimilares) en el plazo de 8 semanas antes de la administración de la primera dosis del fármaco del estudio. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 24 |
El porcentaje de pacientes que obtengan una respuesta del American College of Rheumatology (ACR) 20 en la semana 24. |
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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) |
1. Change From Baseline in the Disability Index of the Health Assessment Questionnaire (HAQ-DI) Score at Week 24 2. Percentage of Participants who Achieve an American College of Rheumatology (ACR) 20 Response at Week 16 3. Percentage of Participants who Achieve an ACR 50 Response at Week 24 4. Percent Improvement in Enthesitis Scores at Week 24 Among Participants with Enthesitis at Baseline 5. Percent Improvement in Dactylitis Scores at Week 24 Among Participants with Dactylitis at Baseline 6. Percentage of Participants who Achieve a Psoriatic Area and Severity Index (PASI) 75 Response at Week 24 |
1.Variación con respecto al valor basal de la puntuación HAQ-DI en la semana 24. 2.Porcentaje de pacientes que obtienen una respuesta ACR 20 en la semana 16. 3.Porcentaje de pacientes que obtienen una respuesta ACR 50 en la semana 24. 4.Mejora porcentual en las puntuaciones de entesitis en la semana 24 entre pacientes con entesitis en el momento basal. 5.Mejora porcentual en las puntuaciones de dactilitis en la semana 24 entre pacientes con dactilitis en el momento basal. 6.Porcentaje de pacientes que obtienen una respuesta PASI 75 en la semana 24. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
- secundary end point 1, 4 & 5 at baseline & week 24 - secundary end point 2 at week 16 - secundary end point 3 & 6 at week 24 |
-Criterio de Valoración secundario 1,4 y 5 en Visita Basal y semana 24 -Criterio de Valoración secundario 2 en semana 16 -Criterio de Valoración secundario 3 y 6 en semana 24 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | Yes |
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 | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 21 |
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 |
Canada |
Germany |
Poland |
Romania |
Russian Federation |
Spain |
United States |
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E.8.7 | Trial 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
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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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |