Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

• Status: Completed
• Trial end date: 1999-08-01
• Target enrollment: 0
• Participant gender: All

Summary

OBJECTIVES:

I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: FDA Office of Orphan Products Development
• Collaborator: University of Massachusetts, Worcester
• Treatments: Efamol; Evening primrose oil

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