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Home > "S" Clinical Trials Conditions > Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis  Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
For Condition: Juvenile Rheumatoid Arthritis
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development , University of Massachusetts Medical Center
Synopsis: OBJECTIVES: I. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 1 Year/15 Years
Genders: Both
Protocol Entry 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
Total Enrollment: 50
Location and Contact Information:
Overall Study Official:
RobertZurier, Study Chair, University of Massachusetts Medical Center
Additional Information:
Study ID Numbers: 199/13314; UMASS-H-2703,UMASS-FDR001067
Study Start Date: September 1994
Record last reviewed: January 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004420
Other Juvenile Rheumatoid Arthritis Studies:
1. Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
2. TNRF:Fc to Treat Eye Inflammation in Juvenile Rheumatoid Arthritis
3. Study of infliximab in combination with methotrexate for the treatment of patients with polyarticular juvenile rheumatoid arthritis
4. Phase I Study of High-Dose Cyclophosphamide, Anti-Thymocyte Globulin, and Total Body Irradiation With T-Cell-Depleted Autologous Bone Marrow Rescue in Patients With High-Risk Rheumatoid Arthritis
5. Pilot Study of Total Body Irradiation in Combination With Cyclophosphamide, Anti-thymocyte Globulin, and Autologous CD34-Selected Peripheral Blood Stem Cell Transplantation in Children With Refractory Autoimmune Disorders
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Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
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