Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00012506
Status:
UNKNOWN
Last Update Posted:
2005-06-24
First Post:
2001-03-10
Brief Title:
The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis
Sponsor:
National Eye Institute NEI
Organization:
National Eye Institute NEI
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2001-03
Last Known Status:
RECRUITING
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 study will investigate the safety and effectiveness of the drug Enbrel TNFRFc to treat uveitis eye inflammation in patients with juvenile rheumatoid arthritis
Detailed Description:
In other studies TNFRFc significantly reduced joint pain and swelling in adult patients with rheumatoid arthritis and the Food and Drug Administration has approved the drug for that use Because medicines for arthritis often help patients with eye inflammation this study will examine whether TNFRFc can help patients with uveitis
Patients with uveitis who are not responding well to standard treatment such as steroids and patients who have side effects from other medicines used to treat their uveitis or have refused treatment because of possible side effects may be eligible for this study Candidates will be screened with a medical history physical examination and eye examination The eye exam includes a check of vision and eye pressure examination of the back of the eye retina and front of the eye including measurements of protein and inflammation Candidates will also undergo fluorescein angiography-a procedure in which photographs are taken of the retina to see if there is any leakage in the eyes blood vessels A blood test and joint evaluation will also be done
Study participants will be given an injection of TNFRFc twice a week for up to 12 months and may continue other medicines they may be taking such as prednisone or methotrexate They will have follow-up examinations at week two and months one two three and four Those who wish to continue treatment after the fourth month can receive the drug for another eight months and will have follow-up exams at months six nine and 12 and one month after treatment ends Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine
Patients with uveitis who are not responding well to standard treatment such as steroids and patients who have side effects from other medicines used to treat their uveitis or have refused treatment because of possible side effects may be eligible for this study Candidates will be screened with a medical history physical examination and eye examination The eye exam includes a check of vision and eye pressure examination of the back of the eye retina and front of the eye including measurements of protein and inflammation Candidates will also undergo fluorescein angiography-a procedure in which photographs are taken of the retina to see if there is any leakage in the eyes blood vessels A blood test and joint evaluation will also be done
Study participants will be given an injection of TNFRFc twice a week for up to 12 months and may continue other medicines they may be taking such as prednisone or methotrexate They will have follow-up examinations at week two and months one two three and four Those who wish to continue treatment after the fourth month can receive the drug for another eight months and will have follow-up exams at months six nine and 12 and one month after treatment ends Each follow-up visit will include a repeat of the screening exams and an evaluation of side effects or discomfort from the medicine
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