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Sponsored by: |
National Eye Institute (NEI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00075075 |
This small, preliminary study will examine whether multiple infusions of infliximab (Remicade® (Registered Trademark)) can control inflammation in patients with active scleritis. The sclera is the tough white outer coat enclosing the eyeball. Infliximab is a combination of part human and part mouse proteins that block a natural body protein called tumor necrosis factor (TNF). TNF appears to be involved in scleritis, and stopping its action may help reduce the inflammation in the disease. The drug has been approved by the Food and Drug Administration for treating Crohn's disease and rheumatoid arthritis.
Patients 18 years of age or older with active non-infectious scleritis may be eligible for this study. Participants will undergo the following tests and procedures:
Patients are seen in the NEI clinic for infusions and to check the response to therapy. This includes 13 clinic visits over 46 weeks, as follows: every 2 weeks for the first 2 weeks, every 4 weeks thereafter for a total of 30 weeks for infusions, and then every 4 weeks for 16 additional weeks.
Patients may stop therapy if their scleritis is not controlled 10 weeks into the study period; if they develop a flare of inflammation after initial control of the active scleritis; if their vision loss is too large; or if their medications increase or other medicines are added to control the scleritis. Patients whose vision decreases minimally, stays the same, or improves may remain in the study.
Condition | Intervention | Phase |
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Scleritis |
Drug: Infliximab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis |
Estimated Enrollment: | 5 |
Study Start Date: | December 2003 |
Estimated Study Completion Date: | September 2007 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
To be eligible to enroll in this study, a prospective participant must satisfy the following inclusion criteria:
EXCLUSION CRITERIA:
To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria:
Study ID Numbers: | 040065, 04-EI-0065 |
Study First Received: | December 31, 2003 |
Last Updated: | September 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00075075 |
Health Authority: | United States: Federal Government |
Infliximab Scleritis Intraocular Inflammatory Disease Corticosteroids Immunosuppressives |
Scleritis Infliximab Eye Diseases |
Anti-Inflammatory Agents Scleral Diseases Therapeutic Uses Gastrointestinal Agents |
Antirheumatic Agents Dermatologic Agents Pharmacologic Actions |