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The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis Clinical research trials and The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis. The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis clinical trial. Subjects often receive the most expert healthcare possible for their The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis  The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis
The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis
For Condition: Uveitis,Arthritis, Juvenile Rheumatoid
Status: Recruiting
Sponsor(s): National Eye Institute (NEI) ,
Synopsis: This study will investigate the safety and effectiveness of the drug Enbrel (TNFR:Fc) to treat uveitis (eye inflammation) in patients with juvenile rheumatoid arthritis.
Details: In other studies, TNFR:Fc 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 TNFR:Fc 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 eye's blood vessels. A blood test and joint evaluation will also be done. Study participants will be given an injection of TNFR:Fc 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.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy Study
Minimum Age/Maximum Age: 2 Years/18 Years
Genders: Both
Protocol Entry Criteria: Must meet American College of Rheumatology Criteria for JRA. Must have active anterior uveitis defined as the presence of inflammatory cells (Grade 1+ or higher) in the anterior chamber of at least one eye or the current use of topical corticosteroids to control exacerbation of disease at a frequency of TID or higher. Age between 2 and 18 years, inclusive. Ability to undergo slit lamp biomicroscopy for assessment of anterior chamber cells. Ability to comply with study requirements. Be up to date on all recommended childhood immunizations. Using current arthritis regimen for at least 8 weeks prior to enrollment. No media opacity that precludes assessment of anterior chamber inflammation. No periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation. Not currently receiving disease modifying antirheumatic therapy (DMARD), with the exception of prednisone at a dose no greater than 1.0 mg/kg/day, or methotrexate at a dose no greater than 15 mg/m(2)/week. No active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications. No females who are pregnant or lactating. No refusal to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists. No use of Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study. No hypersensitivity to fluorescein dye. No active serious infections or history of recurring serious infections. No evidence of spondyloarthropathy or entheseopathy.
Total Enrollment:
Location and Contact Information:
National Institutes of Health *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Susan Smith 391-435-4559
Additional Information:
Study ID Numbers: NEI-82;
Study Start Date:
Record last reviewed: March 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012506
Other Arthritis, Juvenile Rheumatoid Studies:
1. Analysis of Eye Tissue
2. Screening for NEI Clinical Studies
3. Daclizumab Injections to Treat Non-infectious Sight-threatening Uveitis
4. Effect of Pregnancy on Uveitis
5. TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis
Related Studies:
Other Arthritis, Juvenile Rheumatoid Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated with Juvenile Rheumatoid Arthritis
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