Estudio Multicéntrico de Fase 3, Abierto, para Evaluar la Eficacia, Farmacocinética, Seguridad e Inmunogenicidad de ustekinumab o guselkumab Administrados por Vía Subcutánea en Participantes Pediátricos con Artritis Psoriásica Juvenil Activa (PSUMMIT-Jr)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT05083182Tipo: INTERVENTIONALInicio: 30 de ago de 2022Fin estimado: 5 de dic de 2026

Resumen

El propósito de este estudio es evaluar la farmacocinética (FK), eficacia, seguridad e inmunogenicidad de ustekinumab y guselkumab en la artritis psoriásica juvenil activa (APsJ).

Elegibilidad

Edad mínima: 5 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Diagnosis of juvenile psoriatic arthritis (jPsA) by Vancouver criteria with exclusion of enthesitis-related arthritis (ERA). Diagnosis made \>=3 months (that is, 90 days) prior to screening
Active disease in at least greater than or equal to (\>=) 3 joints at screening and at week 0 (defined as swelling or loss of motion with pain and/or tenderness. Swelling alone meets the criteria for an active arthritic joint. In the absence of swelling, loss of motion with pain or tenderness or both pain and tenderness meet the criteria for an active arthritic joint
Have active disease despite previous non-biologic disease modifying anti-rheumatic drug (DMARD) and/or non-steroidal anti-inflammatory drug (NSAID) therapy: Non-biologic DMARD therapy is defined as taking a non-biologic DMARD for at least 12 weeks or evidence of intolerance; NSAID therapy is defined as taking an NSAID for at least 4 weeks or evidence of intolerance
Concurrent use of methotrexate, sulfasalazine, leflunomide, oral corticosteroids or NSAIDs is permitted but must be on stable dose
Participants must be up to date with all immunizations in agreement with current local immunization guidelines for immunosuppressed patients
Prior use of anti-TNFα agents, IL-17 inhibitors and other biologics (except non-responders to IL-23 inhibitors) and JAK inhibitors are permitted with sufficient washout period

Criterios de exclusión

Participants with enthesitis-related arthritis (ERA)
Have a history of latent or active granulomatous infection, including tuberculosis (TB), histoplasmosis, or coccidioidomycosis prior to screening
Have a history of, or ongoing, chronic or recurrent infectious disease
Has evidence of herpes zoster infection within 8 weeks prior to Week 0
Have a known history of hepatitis C infection or test positive at screening

Intervenciones

drug

Ustekinumab

Ustekinumab will be administered as subcutaneous injection.

drug

Guselkumab

Guselkumab will be administered as subcutaneous injection.

Ubicaciones

STAT Research S A

Ciudad Autonoma Buenos Aires, Argentina

Hospital de Ninos de Cordoba

Córdoba, Argentina

Instituto Medico Platense

La Plata, Argentina

Instituto Caici

Rosario, Argentina

Centro Medico Privado de Reumatologia

San Miguel de Tucumán, Argentina

Patrocinadores

PrincipalJanssen Research & Development, LLC

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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