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NCT00075075 · ClinicalTrials.gov registry record · Phase 1
Infliximab to Treat Non-Infectious Scleritis
A Phase 1 study, sponsored by National Eye Institute (NEI).
- Completed
- Registry status
- Phase 1
- Development phase
- 5
- Enrollment target
NCT00075075 is a Phase 1 study that has completed, run by National Eye Institute (NEI). The registered enrollment target is 5 participants.
The verdict
NCT00075075, a Phase 1 study, has completed, sponsored by National Eye Institute (NEI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
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 4
Interventions
- DRUG Infliximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2003-12-23 |
| Est. Completion | 2007-09-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00075075
The ClinicalTrials.gov registry entry for NCT00075075 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Eye Institute (NEI), which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Infliximab is the first listed.
NCT00075075 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00075075 about?
NCT00075075 is a clinical study titled "Infliximab to Treat Non-Infectious Scleritis". 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 ...
What is the current status of trial NCT00075075?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 5 participants. The study started on 2003-12-23. Estimated completion is 2007-09-06.
What interventions are being tested in trial NCT00075075?
The interventions under investigation include: Infliximab (DRUG).
Who is sponsoring clinical trial NCT00075075?
This trial is sponsored by National Eye Institute (NEI), which has 221 total clinical trials registered on ClinicalTrials.gov.
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