LORMYFLong-term Real-world Prospectiv Observational Study on Maintenance Treatment With YISAIPU, an Etanercept Biosimilar, for Patients Wih Rheumatoid Arthritis of Fujian Province of China
Colección de datos
Recopilados desde hoy en adelante - ProspectivoArtritis+5
+ Artritis Reumatoide
+ Enfermedades del Tejido Conectivo
Cohorte
Seguimiento de la incidencia de una enfermedad para identificar factores de riesgo y comprender su progresión a lo largo del tiempo.Resumen
Fecha de inicio: 4 de marzo de 2022
Fecha en la que se inscribió al primer participante.This is a multi-center, prospective, real-world observational study. Patients who have completed 6 months of induction therapy (YISAIPU 50mg / week ± csDMARDs) and achieved clinical remission or low disease activity will be observed for 2.5 years. During the maintenance period, through full communication between doctors and patients, YISAIPU 50 mg/wk or YISAIPU 25 mg/wk will be chosen as maintenance treatment. The clinical efficacy evaluation parameters include DAS28, HAQ-DI, modified Sharp score, continuous medication rate, and the recurrence rate of rheumatoid arthritis. Drug safety evaluation will include the incidence of adverse drug reactions and adverse drug events, the incidence of serious adverse events, and the incidence of adverse events leading to the reduction or withdrawal of YISAIPU due to adverse events. Exploratory observations wil include: (1) the incidence, clinical characteristics and disease changes of Interstitial Lung Disease, (2) the baseline abnormal rate and 3-year change of carotid intima-media thickness.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 500 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Cohorte
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 75 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
Inclusion Criteria: Inclusion criteria: * Meet the ACR revised RA classification criteria(2010); * Disease duration is more than or equal to 6 weeks; * DAS28-CRP\>2.6; * Patient is eligible for TNF inhibitors treatment according to the judgment of the attending doctor in clinical practice; * A written informed consent form must be provided with a signed and signed date prior to the commencement of any study specific procedure. Exclusion Criteria: Exclusion criteria: * Patient has contraindication(s) to the use of fusion-protein type of TNF inhibitor; * Patient is participating in other ongoing drug clinical trials; * Patient whose LTBI screening result is positive, or had not received standard anti-TB treatment for TB history, is unwilling to take prophylactic treatment for TB; * Patient with HBV infection and positive for HBV replication (not up to active replication) is not willing to receive anti-HBV treatment; * Anti-HCV antibody is positive and HCV-RNA is positive, and patient is unwilling to start anti-HCV treatment; * Other reasons the researchers think the patient is not eligible for participation in the study.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.Objetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
The First Affiliated Hospital of Xiamen University
Xiamen, ChinaAbrir The First Affiliated Hospital of Xiamen University en Google Maps