The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis

NCT00012506 | Unknown Phase 3

• 1 other identifier: NEI-82
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Uveitis; Arthritis, Juvenile Rheumatoid

Interventions

TNFR:Fc DRUG

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Eye Institute (NEI): lead

Study Sites (1)

National Institutes of Health

Bethesda, Maryland, 20892, United States

RECRUITING

MeSH Terms

Conditions

Uveitis; Arthritis, Juvenile

Interventions

Etanercept

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fc Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Immunoglobulin Constant Regions; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins; Receptors, Tumor Necrosis Factor; Receptors, Cytokine; Receptors, Immunologic; Receptors, Cell Surface; Membrane Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 10, 2001
• First Posted: March 12, 2001
• Last Updated: June 24, 2005

Record last verified: 2001-03

Locations

US (1)