Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-01-05 @ 10:48 PM
Study NCT ID:
NCT00004420
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001171', 'term': 'Arthritis, Juvenile'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017965', 'term': 'gamma-Linolenic Acid'}], 'ancestors': [{'id': 'D008042', 'term': 'Linolenic Acids'}, {'id': 'D005228', 'term': 'Fatty Acids, Essential'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D043371', 'term': 'Fatty Acids, Omega-6'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1994-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-01', 'completionDateStruct': {'date': '1999-08'}, 'lastUpdateSubmitDate': '2015-03-24', 'studyFirstSubmitDate': '1999-10-18', 'studyFirstSubmitQcDate': '1999-10-18', 'lastUpdatePostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '1999-10-19', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['arthritis & connective tissue diseases', 'juvenile rheumatoid arthritis', 'rare disease'], 'conditions': ['Juvenile Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'OBJECTIVES:\n\nI. Determine the efficacy and safety of gammalinolenic acid in the treatment of childhood arthritis.', 'detailedDescription': "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).\n\nPatients 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.\n\nPatients are followed at 3, 6, 9, and 12 months during study and at 6 months thereafter."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\n* Juvenile rheumatoid arthritis (systemic onset, pauciarticular disease, and polyarticular disease)\n* Active synovitis\n\n--Prior/Concurrent Therapy--\n\n* No more than 2 concurrent nonsteroidal antiinflammatory drugs\n* No more than 2 concurrent second line agents (e.g., D-penicillamine, oral or injectable gold, antimalarials, methotrexate, sulfasalazine)\n* Must have started second line agent at least 3 months prior to study\n* Must be on stable doses of all medications for at least 1 month prior to study\n* Prior prednisone allowed if started at least 3 months prior to study'}, 'identificationModule': {'nctId': 'NCT00004420', 'briefTitle': 'Study of Gammalinolenic Acid for Juvenile Rheumatoid Arthritis', 'organization': {'class': 'FED', 'fullName': 'FDA Office of Orphan Products Development'}, 'orgStudyIdInfo': {'id': '199/13314'}, 'secondaryIdInfos': [{'id': 'UMASS-H-2703'}, {'id': 'UMASS-FDR001067'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'gamma-Linolenic acid', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Robert B. Zurier', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Massachusetts, Worcester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'FDA Office of Orphan Products Development', 'class': 'FED'}, 'collaborators': [{'name': 'University of Massachusetts, Worcester', 'class': 'OTHER'}]}}}