Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis
Data Collection
Eye Diseases
+ Scleral Diseases
+ Scleritis
Treatment Study
Summary
Study start date: December 23, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.5 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
* 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).
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, United StatesSee the location