The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated … (NCT00012506) | Clinical Trial Compass
UnknownPhase 3
The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis
United States
Plain-language summary
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.
Who can participate
Age range2 Years – 18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 t…