Ignite Creation Date:
2025-12-24 @ 7:19 PM
Ignite Modification Date:
2025-12-25 @ 4:58 PM
Study NCT ID:
NCT05182203
Status:
COMPLETED
Last Update Posted:
2023-02-22
First Post:
2021-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001688', 'term': 'Biological Products'}], 'ancestors': [{'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1732}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-20', 'studyFirstSubmitDate': '2021-12-18', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Withdrawal rate due to major / serious adverse events', 'timeFrame': 'from start of biologic/targeted DMARD use to these event(s) up to 10 years', 'description': 'adverse events eg. MACEs, malignancy, infections'}], 'secondaryOutcomes': [{'measure': 'Withdrawal rate due to inefficacy', 'timeFrame': 'from start of biologic/targeted DMARD use to last clinic visit up to 10 years', 'description': 'Efficacy of the agents in terms of retention rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rheumatoid arthitis', 'biological agents', 'targeted agents'], 'conditions': ['Rheumatoid Arthritis', 'Drug Use']}, 'descriptionModule': {'briefSummary': 'This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. These real life data are important as they cannot be provided by randomized controlled trials which are limited by the duration of observation and fixed protocols in research settings. Moreover, data will represent our local experience of the JAK inhibitors in Chinese patients with RA. The retention rate and adverse effects of the JAK inhibitors are compared with conventional TNF inhibitors.', 'detailedDescription': 'This study aims to extract data from the Hong Kong Biologics Registry for retention rate of the JAK inhibitors in rheumatoid arthritis and review other adverse events by looking at the medical record retrospectively. Efficacy data and adverse events, in particular major adverse cardiovascular events (MACEs) and malignancy will be looked at and compared with the TNF inhibitors. Retention / withdrawal rates of the drugs will be studied by statistical analyses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Diagnosis of RA Ever received treatment with any biologic/targeted DMARDs data entered into our Biologics registry age \\>=18 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All RA patients in our biologics registry treated with the JAK inhibitors (N=411)\n* All RA patients in our biologics registry treated with the TNF inhibitors (N=1392)\n\nExclusion Criteria:\n\n\\- RA patients in our biologics registry treated with other biologic/targeted DMARDs'}, 'identificationModule': {'nctId': 'NCT05182203', 'briefTitle': 'Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Tuen Mun Hospital'}, 'officialTitle': 'Safety and Retention Rate of the JAK and TNF Inhibitors in Rheumatoid Arthritis: a Real-life Experience', 'orgStudyIdInfo': {'id': 'HKSRJAK study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'JAK inhibitors', 'description': 'RA patients treated with JAK inhibitors', 'interventionNames': ['Drug: biologic/targeted therapy']}, {'label': 'TNF inhibitors', 'description': 'RA patients treated with TNF inhibitors', 'interventionNames': ['Drug: biologic/targeted therapy']}], 'interventions': [{'name': 'biologic/targeted therapy', 'type': 'DRUG', 'description': 'TNF inhibitors or the JAK inhibitors', 'armGroupLabels': ['JAK inhibitors', 'TNF inhibitors']}]}, 'contactsLocationsModule': {'locations': [{'zip': '000', 'city': 'Hong Kong', 'country': 'China', 'facility': 'Department of Medicine, Tuen Mun Hospital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Chi Chiu Mok, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tuen Mun Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tuen Mun Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Consultant', 'investigatorFullName': 'Chi Chiu Mok', 'investigatorAffiliation': 'Tuen Mun Hospital'}}}}