Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00075075
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2003-12-31
Brief Title:
Infliximab to Treat Non-Infectious Scleritis
Sponsor:
National Eye Institute NEI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Pilot Study of the Evaluation of Infliximab in the Treatment of Non-Infectious Scleritis
Status:
COMPLETED
Status Verified Date:
2007-09-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Crohns 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 patients 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
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 patients 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
Detailed Description:
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 5mgkg intravenous infusions of infliximab at 0 2 6 and 10 weeks After these initial infusions participants may contine to receive 5 mgkg dose infusions or may receive 8 mgkg 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 mgkg or 8 mgkg 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 inflammationscleritis 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 452 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 04-EI-0065 | None | None | None |