Ignite Creation Date:
2025-12-25 @ 2:35 AM
Ignite Modification Date:
2025-12-31 @ 10:51 AM
Study NCT ID:
NCT04454034
Status:
UNKNOWN
Last Update Posted:
2021-06-28
First Post:
2020-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
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': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-25', 'studyFirstSubmitDate': '2020-06-27', 'studyFirstSubmitQcDate': '2020-06-27', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR70 remission', 'timeFrame': '6 months after surgery', 'description': 'the percent of patients who meet ACR70 remission'}], 'secondaryOutcomes': [{'measure': 'Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)', 'timeFrame': '1,3,6 and 12 months after surgery', 'description': 'Remission: 2.6 Low activity: 2.6 to ,3.2 Moderate activity: 3.2 to 5.1 High activity: .5.1'}, {'measure': 'tender joint count', 'timeFrame': '1,3,6 and 12 months after surgery', 'description': 'the number of tender joints'}, {'measure': 'swollen joint count', 'timeFrame': '1,3,6 and 12 months after surgery', 'description': 'the number of swollen joints'}]}, 'conditionsModule': {'keywords': ['Rheumatoid Arthritis', 'Arthroscopic Synovectomy'], 'conditions': ['Rheumatoid Arthritis of Ankle']}, 'descriptionModule': {'briefSummary': 'Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'the patients who fullfill the Eligibility Criteria', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria.\n* The age is more than 18 years old and less than 60 years old.\n* They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months.\n* The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited.\n* The patient agreed to undergo arthroscopic synovectomy.\n* No contraindications were found.\n\nExclusion Criteria:\n\n* The disease is in remission.\n* The patient has contraindications.\n* Arthroscopic synovectomy was performed in different patients.'}, 'identificationModule': {'nctId': 'NCT04454034', 'briefTitle': 'Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'M2019072'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group1', 'description': 'The refractory elbow RA who undergo arthroscopic synovectomy', 'interventionNames': ['Procedure: arthroscopic synovectomy']}], 'interventions': [{'name': 'arthroscopic synovectomy', 'type': 'PROCEDURE', 'description': 'arthroscopic synovectomy', 'armGroupLabels': ['Group1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100191', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking Univerisity Third Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}