Infliximab to Treat Non-Infectious Scleritis

Completed · Phase 1

Conditions studied: Scleritis

In brief

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: * Medical history and physical examination. * Eye examination, including a vision test and examination of the retina (back part of the eye) and of the sclera and its blood vessels. * Questionnaire about vision and daily activities. * Tuberculin skin test. * Pregnancy test: Women who can have children are tested for pregnancy at study weeks 0, 14, 30, 38, and 46. * Infliximab treatment: Infliximab is infused over a 2-hour period through a needle in a vein, usually in the arm. The patient's vital signs are checked before the patient begins each infusion starts and again before leaving the clinic. After the first two infusions, if the disease remains quiet, other scleritis medications will be attempted to be reduced to half the original dose over 8 to 12 weeks and possibly to nothing if the patient continues to do well. Patients receive a maximum of 9 infusions over a 30-week period. * Blood draws: About 4 tablespoons of blood are drawn at each visit to test for the number and types of cells in the blood and to check for signs of inflammation and side effects of the study medicine. 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.

Key facts

Study ID

NCT00075075

Run by

National Eye Institute (NEI)

People needed

5

Starts

2003-12-23

Expected to finish

2007-09-06

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• To be eligible to enroll in this study, a prospective participant must not satisfy any of the following exclusion criteria:
• 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.
• Participant with a corneal melting, necrotizing keratitis, or impending vision loss.
• Participant with scleritis of infectious etiology.
• 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.
• Participant has significant active infection requiring hospitalization.
• Participant with multiple sclerosis.
• Participant has severe (class 3/4) congestive heart failure.
• Participant has a history of cancer within the past 5 years other than basal or squamous cell carcinoma.
• Participant is pregnant or lactating as it is unknown whether infliximab is excreted in human milk or absorbed systemically after ingestion.
• Evidence of liver disease (any etiology).

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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