The Safety and Efficacy of a Tumor Necrosis Factor Receptor Fusion Protein on Uveitis Associated With Juvenile Rheumatoid Arthritis
Enbrel
Arthritis+12
+ Autoimmune Diseases
+ Connective Tissue Diseases
Treatment Study
Summary
Study start date: February 1, 1999
Actual date on which the first participant was enrolled.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 randomized with a 2 to 1 randomization plan (10 to receive Etanercept, 5 to receive placebo) and followed for 6 months. After the 6 month visit, all patients will receive open label Etanercept for an additional 6 months. Patients will be switched to open label Etanercept, or withdrawn from study therapy prior to 6 months, if they a) experience a greater than 10 letter or greater drop in visual acuity due to inflammation, for patients using the ETDRS chart (a 2 line drop due to inflammation, for patients using the B-VAT method) or b) develop a sight-threatening inflammatory ophthalmic or joint lesion requiring immediate increase in systemic anti-inflammatory therapy or a periocular injection of corticosteriods or c) at 4 months, have greater than 1 plus anterior chamber cell grade in either eye and are receiving topical corticosteroids on a schedule of TID or more frequently. Investigators will remain masked to original treatment assignment unless warranted by clinical care considerations. Primary safety outcomes include the occurrence of any severe adverse event at least possibly related to study therapy, including a two step increase in anterior chamber cells, or the occurrence of serious infection or sepsis. Primary ophthalmic outcomes include measures of anterior chamber cells and a change in topical or systemic anti-inflammatory medications used to treat uveitis. Primary ophthalmic and JRA outcome analysis will be performed at 6 months, and again at 12 months. Patients unmasked or switched to open label Etanercept prior to month 6 or withdrawing from the study drug prior to month 12 will be considered failures.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.15 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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.
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location