Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

Juvenile Rheumatoid Arthritis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00004420
• Other study ID #: 199/13314
• Secondary ID: UMASS-H-2703UMAS
• Status: Completed
• Phase: N/A
• First received: October 18, 1999
• Last updated: March 24, 2015
• Start date: September 1994
• Est. completion date: August 1999

Study information

• Verified date: January 2000
• Source: FDA Office of Orphan Products Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES:

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 15 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Arthritis, Rheumatoid
• Juvenile Rheumatoid Arthritis

Intervention

Drug:
• gamma-Linolenic acid

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
FDA Office of Orphan Products Development	University of Massachusetts, Worcester