Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

FDA Office of Orphan Products Development

Status

Completed

Conditions

Juvenile Rheumatoid Arthritis

Treatments

Drug: gamma-Linolenic acid

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00004420

UMASS-FDR001067

199/13314

UMASS-H-2703

Details and patient eligibility

About

OBJECTIVES:

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

Full 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.

Sex

All

Ages

1 to 15 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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