Ignite Creation Date:
2025-12-24 @ 12:42 PM
Ignite Modification Date:
2026-02-27 @ 6:49 AM
Study NCT ID:
NCT02471261
Status:
COMPLETED
Last Update Posted:
2020-10-23
First Post:
2015-06-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Elastography as Gouty Arthropathy Outcome (EGO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006073', 'term': 'Gout'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D000070657', 'term': 'Crystal Arthropathies'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D011686', 'term': 'Purine-Pyrimidine Metabolism, Inborn Errors'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-10-22', 'studyFirstSubmitDate': '2015-06-11', 'studyFirstSubmitQcDate': '2015-06-11', 'lastUpdatePostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Elastography as Gouty Arthropathy Outcome (EGO), a pilot study', 'timeFrame': '1 year', 'description': 'Observational trial to measure gouty arthritis changes in subject taking urate lowering therapies'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.', 'detailedDescription': 'Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects who are at least 18 years of age but younger than or equal to 99 years of age.\n2. Subjects with gouty arthritis as determined by the ACR 1977 classification criteria for gouty arthritis.\n3. Subjects with one palpable tophus detectable by one of the three clinical parameters described.\n\n \\-\n\nExclusion Criteria:\n\n1. Subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds.\n2. Subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic, renal or endocrine dysfunction who in the opinion of the principal investigator are unfit for participation in a clinical trial.\n3. Subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated.\n\n \\-'}, 'identificationModule': {'nctId': 'NCT02471261', 'briefTitle': 'Elastography as Gouty Arthropathy Outcome (EGO)', 'organization': {'class': 'OTHER', 'fullName': 'Arthritis & Rheumatism Associates, P.C.'}, 'officialTitle': 'Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.', 'orgStudyIdInfo': {'id': 'ESR-14-10146'}}, 'contactsLocationsModule': {'locations': [{'zip': '20902', 'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Center for Rheumatology and Bone Research', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arthritis & Rheumatism Associates, P.C.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}