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Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

Primary Purpose

Juvenile Rheumatoid Arthritis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gamma-Linolenic acid
Sponsored by
FDA Office of Orphan Products Development
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Rheumatoid Arthritis focused on measuring arthritis & connective tissue diseases, juvenile rheumatoid arthritis, rare disease

Eligibility Criteria

1 Year - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    March 24, 2015
    Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    University of Massachusetts, Worcester
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004420
    Brief Title
    Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1994 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    August 1999 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    FDA Office of Orphan Products Development
    Collaborators
    University of Massachusetts, Worcester

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Juvenile Rheumatoid Arthritis
    Keywords
    arthritis & connective tissue diseases, juvenile rheumatoid arthritis, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    50 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    gamma-Linolenic acid

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert B. Zurier
    Organizational Affiliation
    University of Massachusetts, Worcester
    Official's Role
    Study Chair

    12. IPD Sharing Statement

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    Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis

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