Recruiting
Phase 3

Tumor Necrosis Factor Receptor

Sponsor:

National Eye Institute (NEI)

Code:

NCT00012506

Conditions

Uveitis

Arthritis, Juvenile Rheumatoid

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

Interventions

TNFR:Fc

Study Details

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

Study ID

NCT00012506

Status verified date

Mar, 2001

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

TNFR:Fc

Central Contacts and Locations

Locations

National Institutes of Health

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

Principal Investigator:

Janine A Smith, M.D.

More Information

Sponsor

National Eye Institute (NEI)

Last update posted

Jun 24, 2005

Last verified

Mar, 2001

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Eye Institute (NEI) on 2005-06-24.