Etanercept Therapy for Sjogren's Syndrome
Etanercept
Artritis+13
+ Artritis Reumatoide
+ Enfermedades Autoinmunes
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de diciembre de 1999
Fecha en la que se inscribió al primer participante.Sjogren's syndrome (SS) is an autoimmune disease chiefly affecting the exocrine glands. Manifestations of SS include salivary and lacrimal gland dysfunction. There is no generally accepted treatment for the underlying autoimmune reactivity or the exocrine gland dysfunction in SS. We propose to test the effects of etanercept therapy. In a randomized, double-masked, outpatient protocol, patients will receive etanercept for 2 times/week for 3 months. Therapy will be given by subcutaneous injection. Efficacy of treatment will be assessed by monitoring salivary and lacrimal function, serological markers of autoimmune activity, and subjective reports of local and systemic symptoms. The present trial will serve as a screening protocol to identify if etanercept should be further analyzed in a larger clinical trial for efficacy.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 28 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
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.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
INCLUSION CRITERIA Documented primary or secondary SS. Absence of confounding health problems. No contraindications to etanercept therapy. SS patients cannot have sarcoidosis, HIV infection, or lymphoma. Patients must have one of the following abnormal autoimmune serologies associated with SS (i.e. positive ANA, RF, and anti-SS-A, or anti-SS-B). Patients may use pilocarpine provided that they hold their dose on visit days when saliva is collected. Patients taking DMARD's, such as hydroxychloroquine, must be on a stable dose. Participants may take NSAIDs or acetaminophen. EXCLUSION CRITERIA Patients must not have physical or mental conditions that may make them unable to comply. Subjects may continue their other long-term medications with the exception of tricyclic antidepressants and anti-cholinergics, which may affect salivary gland function. Patients cannot take experimental drugs during the duration of the protocol. Children will be excluded due to additional risks that may occur with etanercept.
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
National Institute of Dental And Craniofacial Research (NIDCR)
Bethesda, United StatesAbrir National Institute of Dental And Craniofacial Research (NIDCR) en Google Maps