Completed

Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

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What is being tested

gamma-Linolenic acid

Drug
Who is being recruted

Autoimmune Diseases+10

+ Immune System Diseases

+ Joint Diseases

From 1 to 15 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 1994
See protocol details

Summary

Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 1994

Actual date on which the first participant was enrolled.

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.

NCT00004420
Principal SponsorFDA Office of Orphan Products Development
Last updated: March 25, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

50 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 15 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Autoimmune DiseasesImmune System DiseasesJoint DiseasesMusculoskeletal DiseasesPathologic ProcessesRheumatic DiseasesPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesDisease AttributesArthritisArthritis, JuvenileConnective Tissue DiseasesRare Diseases

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

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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CompletedNo study centers