Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT00858169
Status:
COMPLETED
Last Update Posted:
2015-02-13
First Post:
2009-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Wrist Joint and Knee Joint Inflammation in Patients With Rheumatoid Arthritis by Quantitative Three Dimensional Power Doppler Ultrasonography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-12', 'studyFirstSubmitDate': '2009-03-06', 'studyFirstSubmitQcDate': '2009-03-06', 'lastUpdatePostDateStruct': {'date': '2015-02-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between 2D- and 3D-PDUS quantification data and clinical data, including pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)', 'timeFrame': 'cross-sectional'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['three-dimensional power Doppler ultrasonography', 'wrist', 'knee', 'rheumatoid arthritis'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to:\n\n1. To investigate the wrist joint synovial blood flow intensity and model by quantitative three-dimensional (3D) power Doppler ultrasonography (PDUS) in patients with rheumatoid arthritis before and after initiation of a new medicine and compare these data with routinely used clinical data and laboratory findings, such as pain score, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP)\n2. To investigate the intra-observer and inter-observer agreement of quantitative 3D PDUS assessment of the vascularity in wrist joints and knee joints using automatic volume scan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'A total of 30 patients with RA who visit outpatient clinic of Rheumatology at Taichung Veterans General Hospital (TCVGH) will be enrolled consecutively at if they met the study inclusion criteria', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who fulfill the 1987 ARA criteria for RA\n* Patients with at least one painful swollen wrist or knee joint observed by a rheumatologist\n* Patients who will receive a new medicine, including oral corticosteroid, intravenous methylprednisolone pulse therapy, intraarticular injection with steroid or methotrexate, DMARDs, or biologic agent\n\nExclusion Criteria:\n\n* Patients with active infection\n* Patients with concurrent malignant disease\n* Patients with a history of traumatic, septic, or cystal arthritis, previous joint surgery, or arthroscopic synovectomy of any wrist or kneejoint within the past 12 months before the study\n* Patients who have severe wrist or knee joint deformity that makes the US assessment protocol unable to complete'}, 'identificationModule': {'nctId': 'NCT00858169', 'acronym': '3D sono in RA', 'briefTitle': 'Assessment of Wrist Joint and Knee Joint Inflammation in Patients With Rheumatoid Arthritis by Quantitative Three Dimensional Power Doppler Ultrasonography', 'organization': {'class': 'OTHER', 'fullName': 'Taichung Veterans General Hospital'}, 'officialTitle': 'Taichung Veterans General Hospital', 'orgStudyIdInfo': {'id': 'C09044'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taichung Veterans General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Taichung Veterans General Hospital', 'investigatorFullName': 'TCVGH', 'investigatorAffiliation': 'Taichung Veterans General Hospital'}}}}