Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis
Colección de datos
Enfermedades Oculares
+ Escleritis
+ Enfermedades de la Esclerótica
Estudio de Tratamiento
Resumen
Fecha de inicio: 23 de diciembre de 2003
Fecha en la que se inscribió al primer participante.We propose to investigate the possible efficacy of multiple infliximab infusions to control the inflammation in participants presenting with active scleritis. This will be performed using an open-label pilot study. Subjects will receive 5mg/kg intravenous infusions of infliximab at 0, 2, 6 and 10 weeks. After these initial infusions, participants may contine to receive 5 mg/kg dose infusions or may receive 8 mg/kg dose infusions depending on the treamtent response. Treatment response is defined as a decrease in inflammation by at least 2 steps on the scale of grades 0-4 , or a decrease to 0 assessed at week 14. A combination of thse two dose infusions (5 mg/kg or 8 mg/kg) will be given for the remainder of the study according to set schedules. The primary outcome will be the ability to control active scleritis defined as at least a 2-step decrease in sleral inflammation,scleritis within 14 weeks of initiating infliximab therapy. Secondary outcomes will be the amount of reduction in concomitant immunosuppressive medication (measured using the grading scale in Section 4.5.2), changes in pain, redness (measured using a visual analogue scale), photophobia, changes in visual acuity (changes of 10 letters from baseline in best-corrected visual acuity will be considered clinically significant), the typical time between flares, and numbers of flares and times between flares while in the study.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 5 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.A partir de 18 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: To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria: 1. Participant is 18 years of age or older. 2. Participant has active non-infectious scleritis, diagnosed by a persistent congestion of deep episcleral vessels following a drop of 10% phenylephrine, without active intraocular inflammation. 3. Participant has normal renal or liver function. 4. Participant agrees to use acceptable birth control methods throughout the course of the study and for 6 months after completion of treatment. 5. Participant has no evidence of tuberculosis as documented by tuberculin skin test performed prior to enrollment (chest x-ray, if medically indicated). 6. Participant is able to understand and sign a consent form before entering the study. 7. Participant has been treated with prednisone or other immunomodulatory medications but present with active disease at the time of enrollment. EXCLUSION CRITERIA: To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria: 1. Participant with a known underlying systemic disease with evidence of serious or potentially lethal uncontrolled active disease in one or more extraocular organ systems for which a defined effective medical regimen is indicated. 2. Participant with a corneal melting, necrotizing keratitis, or impending vision loss. 3. Participant with scleritis of infectious etiology. 4. Participant receiving any other investigational therapy or another anti-TNF agent that would interfere with the ability to evaluate the safety or efficacy of infliximab. 5. Participant has significant active infection requiring hospitalization. 6. Participant with multiple sclerosis. 7. Participant has severe (class 3/4) congestive heart failure. 8. Participant has a history of cancer within the past 5 years other than basal or squamous cell carcinoma. 9. Participant is pregnant or lactating as it is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion. 10. Evidence of liver disease (any etiology).
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 Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesVer ubicación