Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

FDA Office of Orphan Products Development50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Juvenile Rheumatoid Arthritis

Interventions

gamma-Linolenic acidDRUG

Eligibility

Sex: ALLMin age: 1 YearMax age: 15 Years

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.