Juvenile Rheumatoid Arthritis
Conditions
Keywords
arthritis & connective tissue diseases, juvenile rheumatoid arthritis, rare disease
Brief summary
OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
Detailed description
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, cross over study of 12 months duration. Patients are stratified by type of juvenile rheumatoid arthritis (systemic onset vs pauciarticular disease vs polyarticular disease). Patients are randomized to receive either gammalinolenic acid (GLA) or placebo (safflower seed oil) orally. Parents are asked to maintain the child's usual diet over the course of study. Patients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter.
Interventions
Sponsors
University of Massachusetts, Worcester
FDA Office of Orphan Products Development
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
1 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- * Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease) * Active synovitis --Prior/Concurrent Therapy-- * No more than 2 concurrent nonsteroidal antiinflammatory drugs * No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine) * Must have started second line agent at least 3 months prior to study * Must be on stable doses of all medications for at least 1 month prior to study * Prior prednisone allowed if started at least 3 months prior to study
Outcome results
None listed