Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

This study has been completed.

First Received on October 18, 1999. Last Updated on June 23, 2005 History of Changes

Sponsor:	FDA Office of Orphan Products Development
Collaborator:	University of Massachusetts, Worcester
Information provided by:	FDA Office of Orphan Products Development
ClinicalTrials.gov Identifier:	NCT00004420

Purpose

OBJECTIVES:

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

Condition	Intervention
Juvenile Rheumatoid Arthritis	Drug: gamma-Linolenic acid

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

Resource links provided by NLM:

Genetics Home Reference related topics: juvenile idiopathic arthritis

MedlinePlus related topics: Connective Tissue Disorders Juvenile Rheumatoid Arthritis Rheumatoid Arthritis

Drug Information available for: gamma-Linolenic acid

U.S. FDA Resources

Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment:	50
Study Start Date:	September 1994
Estimated Study Completion Date:	August 1999

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.

Eligibility

Ages Eligible for Study:	1 Year to 15 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004420

Sponsors and Collaborators

FDA Office of Orphan Products Development

University of Massachusetts, Worcester

Investigators

Study Chair:

Robert B. Zurier

University of Massachusetts, Worcester

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00004420 History of Changes
Other Study ID Numbers:	199/13314, UMASS-H-2703, UMASS-FDR001067
Study First Received:	October 18, 1999
Last Updated:	June 23, 2005
Health Authority:	United States: Federal Government

Keywords provided by FDA Office of Orphan Products Development:

arthritis & connective tissue diseases
juvenile rheumatoid arthritis
rare disease

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Arthritis, Juvenile Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Efamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics

Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Dermatologic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012