TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis

Launched by NATIONAL EYE INSTITUTE (NEI) · Nov 3, 1999

Keywords

ClinConnect Summary

Current treatment modalities for uveitis associated with Juvenile Rheumatoid Arthritis (JRA) including corticosteroids and other immunosuppressive agents are associated with significant side effects. These treatments are not effective for all children. A soluble tumor necrosis factor receptor (TNFR:Fc) named Etanercept, may inhibit the inflammatory response of uveitis. This randomized double-masked phase I/II clinical trial will provide limited safety and efficacy information regarding the use of Etanercept for the treatment of uveitis associated with JRA. Fifteen patients will be randomize...

Gender

ALL

Eligibility criteria

• INCLUSION CRITERIA:
• • Meet American College of Rheumatology Criteria for JRA.
• • 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.
• • Be between 2 and 18 years, inclusive.
• • Be able to undergo slit lamp biomicroscopy for assessment of anterior chamber cells.
• • Be able to comply with study requirements.
• • Be up to date on all recommended childhood immunizations.
• • Have been using current arthritis regimen for at least 8 weeks prior to enrollment.
• EXCLUSION CRITERIA:
• • Have a media opacity that precludes assessment of anterior chamber inflammation.
• • Have a periocular injection of corticosteroids within 2 months of baseline, or used a systemic experimental therapy within one month of baseline evaluation.
• • Be 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.
• • Have active eye or joint inflammation requiring immediate addition or increase in systemic anti-inflammatory medications.
• • Be a Female who is pregnant or lactating .
• • Refuse to use contraception during the study and 6 months after termination of active study therapy, if child-bearing or fathering potential exists.
• • Have used Latanoprost within two weeks prior to enrollment, or have a current or likely need for Latanoprost during the course of the study.
• • Have hypersensitivity to fluorescein dye.
• • Have active serious infections or history of recurring serious infections.
• • Evidence of spondyloarthropathy or entheseopathy.