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The Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis

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Qué se está recopilando

Recolección de datos

Quiénes están siendo reclutados

Arthritis
+2

+ Arthritis, Reactive
+ Arthritis, Rheumatoid
Cómo está diseñado el estudio

Other

Observacional
Inicio del estudio: agosto de 1994

Resumen

Patrocinador PrincipalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Última actualización: 4 de marzo de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio
Fecha de inicio: 1 de agosto de 1994Fecha en la que se inscribió al primer participante.

This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies. This study will evaluate patients with inflammatory forms of arthritis within the first year of onset. The study will attempt to clarify factors that may predict disease course such as evolution into rheumatoid arthritis (RA) or other chronic inflammatory arthropathies. Synovial biopsies and synovial fluid will be obtained to search for microbial agents and other initiating and modulating factors that may be most readily distinguished early in the disease and to determine the stage of disease at which certain immunologic and hormonal changes become evident. The study will also search for genetic and other features that may be associated with specific forms of inflammatory arthropathies that might predict the subsequent clinical disease course or response to different agents used in treatment of RA, Reiter's syndrome and other types of chronic inflammatory arthropathies.

Título OficialThe Pathogenesis of Inflammatory Synovitis: A Study of Early Arthritis 
Patrocinador PrincipalNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Última actualización: 4 de marzo de 2008
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño
Se reclutarán 500 pacientesNúmero total de participantes que el ensayo clínico espera reclutar.

Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios
Cualquier sexoSexo biológico de los participantes elegibles para inscribirse.
Voluntarios sanos permitidosIndica si personas sanas, sin la condición que se estudia, pueden participar.
Condiciones
Patología
Arthritis
Arthritis, Reactive
Arthritis, Rheumatoid
Reiter's Disease
Synovitis
Criterios

Patients to be studied will be required to have an inflammatory arthritis of less than one year's duration. Patients must be greater than 18 years of age. Pregnant patients may be entered into the study, but they will not undergo percutaneous needle biopsy or joint radiographs. No patients with known bacterial septic arthritis, crystal-induced, or degenerative arthritis. Synovial biopsies will not be performed if patients have platelet counts less than 70,000/mm(3), other bleeding diathesis in the skin over the joint or sepsis. Joint MRI: Patient must currently be evaluated at the NIH through protocol 94-AR-0194 or 98-AR-0150. Joint MRI: Patient must have at least one clinically active arthritic joint that is under consideration for percutaneous needle synovial biopsy. Joint MRI: Patients must not have the following: cardiac pacemakers, auto defibrillators, neural stimulators, aneurysm clips, metallic prostheses, cochlear (ear) implants, any implanted devices (pumps, infusion devices, etc.), metal fragments in the eye, or shrapnel injuries. Joint MRI: Patients must not exceed the size limitations of the MRI scanner. Joint MRI: Must not suffer from claustrophobia. Joint MRI: Must not have had a previous anaphylactoid reaction to gadolinium-based contrast material. Joint MRI: Must not be pregnant.



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
Suspendido
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Bethesda, United StatesVer ubicación

Completado1 Centros de Estudio