Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

Sponsor

FDA Office of Orphan Products Development (U.S. Fed)

Overall Status

Completed

CT.gov ID

NCT00004420

Collaborator

University of Massachusetts, Worcester (Other)

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

OBJECTIVES:

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

Condition or Disease	Intervention/Treatment	Phase
Juvenile Rheumatoid Arthritis	Drug: gamma-Linolenic acid	N/A

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double

Primary Purpose:

Treatment

Study Start Date :

Sep 1, 1994

Study Completion Date :

Aug 1, 1999

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 15 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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