Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

NCT ID: NCT00004420

Last Updated: 2015-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1994-09-30
• Study Completion Date: 1999-08-31

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.

Conditions

Juvenile Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

gamma-Linolenic acid

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: collaborator

FDA Office of Orphan Products Development

FED

Sponsor Role: lead

Principal Investigators

Robert B. Zurier

Role: STUDY_CHAIR

University of Massachusetts, Worcester

Other Identifiers

UMASS-H-2703

Identifier Type: -

Identifier Source: secondary_id

UMASS-FDR001067

Identifier Type: -

Identifier Source: secondary_id

199/13314

Identifier Type: -

Identifier Source: org_study_id