Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis
Collecte de données
Maladies oculaires
+ Maladies de la sclère
+ Sclérite
Étude thérapeutique
Résumé
Date de début de l'étude : 23 décembre 2003
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.5 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
* 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).
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesVoir le site