The Safety and Efficacy of Chicken Type II Collagen on Uveitis Associated With Juvenile Rheumatoid Arthritis
Chicken type II collagen
Artritis+15
+ Enfermedades Autoinmunes
+ Enfermedades del Tejido Conectivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 1997
Fecha en la que se inscribió al primer participante.Current treatment modalities for uveitis associated with juvenile rheumatoid arthritis have not been beneficial in the juvenile population. A new approach for treating patients with presumed autoimmune disorders is oral tolerance therapy. Chicken type II collagen (Colloral) is being developed as an oral tolerance therapy for the treatment of rheumatoid arthritis. This open label pilot study will describe the safety of chicken type II collagen added to current anti-inflammatory medications as treatment for patients with uveitis associated with juvenile rheumatoid arthritis. The primary ophthalmic outcomes of this study will be a change from baseline in the number of anterior chamber cells and the number and dosage of anti-inflammatory medications. Secondary outcomes for JRA will include change in physician's global assessment, parent/patient assessment of overall well-being, functional assessment, number of joints with active arthritis, number of joints with limited range of motion, and erythrocyte sedimentation rate (ESR). Secondary outcomes for uveitis will include change in visual acuity, vitreous haze, and anterior chamber flare.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 13 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
Must meet American College of Rheumatology Criteria for JRA. Must have active anterior uveitis defined as the presence of inflammatory cells in the anterior chamber in at least one eye, or the current use of topical corticosteroids. Must be between 2 and 18 years of age, inclusive. Must have had previous therapy for uveitis. Must be able to undergo a slit lamp biomicroscopy for assessment of anterior chamber cells. Must not have a media opacity that precludes assessment of anterior chamber inflammation. Must not have received a periocular injection of corticosteroids within 2 months of baseline. Must not be currently receiving DMARD (disease modifying anti-rheumatic) therapy, with the exception of prednisone at a dose no greater than 1.5-2.0 mg/kg/day, or methotrexate at a dose no greater than 10 mg/m(2)/week. Must not have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications. Must not have involvement in prior clinical trials of type II collagen. Must not have exposure within the past year to shark or other collagen preparations found in health food stores. Must not have a history of gastrointestinal disease which could affect the presentation of type II collagen. Women must not be pregnant or lactating. Patients currently using Latanoprost, patients who have used Latanoprost within the last 2 weeks, or patients who are likely to need Latanoprost during the course of the study will be excluded.
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 Eye Institute (NEI)
Bethesda, United StatesAbrir National Eye Institute (NEI) en Google Maps