Calendario›AMGN›Pegloticase
Pegloticase
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
Ensayo de AMGEN INC en Gota Incontrolada.
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 11
- Centros
- 15
- Fin del objetivo primario
- ago 2022
Qué significa cada fase y cada estado.
Estudio de intervención, de un solo grupo, abierto. Comenzó en mar 2021.
Qué mide
Porcentaje de respondedores de acido urico serico (sUA) (sUA < 6 mg/dL) durante el mes 6. (mes 6)
Qué se prueba
Se prueba pegloticase combinada con metotrexato durante aproximadamente 24 semanas, con posible extensión hasta 48 semanas, en adultos con gota incontrolada que recibieron pegloticase previamente sin un inmunomodulador concomitante.
Lo que dice el documentoThis is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain serum uric acid (sUA) response and/or a clinically mild infusion reaction (IR). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks.
Traducción automática (claude-haiku-4-5-20251001). Lo comprobado es la cita: está literal en el documento y sus cifras cuadran con las de la frase. Todavía no la ha leído una persona.
Cómo lo describe el promotor
En el documentoEn inglés, del registroThis is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped pegloticase due to failure to maintain serum uric acid (sUA) response and/or a clinically mild infusion reaction (IR). Approximately 30 participants will be enrolled. Pegloticase + MTX will be administered for approximately 24 weeks, with an optional extension up to 48 weeks. The trial design will include 5 distinct components: 1. Screening Period, lasting up to 42 days; 2. 6-week MTX Tolerability Assessment Period (hereafter referred to as the MTX Run-in Period); 3. 24-week Pegloticase + MTX Treatment Period, which will include a Week 24/End of Trial/Early Termination Visit (subjects that end MTX and pegloticase treatment prior to the Week 24 will remain on trial for follow up until the Week 24 visit) 4. Optional Pegloticase + MTX Extension Period up to 24 weeks 5. 30-Day Post Treatment Follow -up
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Todos los de AMGN, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT04772313), actualizada en jun 2024.