Ignite Creation Date:
2025-12-24 @ 3:20 PM
Ignite Modification Date:
2025-12-24 @ 3:20 PM
Study NCT ID:
NCT04324892
Status:
UNKNOWN
Last Update Posted:
2023-09-06
First Post:
2020-03-25
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study
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': 110}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-04', 'studyFirstSubmitDate': '2020-03-25', 'studyFirstSubmitQcDate': '2020-03-25', 'lastUpdatePostDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of achieving Sustained SDAI remission (SDI group) on the progression of joint space size and volume compared to those who cannot achieve sustained SDAI remission (non-SDI group)', 'timeFrame': '12 months', 'description': 'To study the effect of achieving Sustained SDAI remission at 6, 9 and 12 months (SDI group) on the progression of joint space size and volume over a period of 12 months as evaluated by HR-pQCT compared to those who cannot achieve sustained SDAI remission (non-SDI group)'}], 'secondaryOutcomes': [{'measure': 'Changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score at 12 months between the SDI group and non-SDI group', 'timeFrame': '12 months', 'description': 'To study the changes in size of erosion and marginal osteosclerosis using HR-pQCT, and SvDH score by convention X-ray at 12 months between the SDI group and non-SDI group'}, {'measure': 'Changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.', 'timeFrame': '12 months', 'description': 'To investigate the changes in joint space and erosion size as a function of inflammatory activity as reflected by the time-averaged SDAI.'}, {'measure': 'Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI', 'timeFrame': '6 months', 'description': 'To investiage the association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI to determine the impact of joint damage on reversible and non-reversible disability.'}, {'measure': 'Association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI', 'timeFrame': '12 months', 'description': 'To investiage the association between the changes in joint space and erosion size on HR-pQCT and HAQ-DI to determine the impact of joint damage on reversible and non-reversible disability.'}, {'measure': 'Association between the changes in SvdH score and HAQ-DI over a period 12 months', 'timeFrame': '12 months', 'description': 'To investigate the association between the changes in SvdH score and HAQ-DI'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Rheumatoid Arthritis', 'Treat to target', 'HRpqCT', 'Joint space narrowing', 'SDAI remission'], 'conditions': ['Rheumatoid Arthritis']}, 'descriptionModule': {'briefSummary': "Objectives:\n\nTo elucidate the effects of achieving sustained simple disease activity index (SDAI) remission in the progression of joint space outcomes using high-resolution peripheral quantitative CT (HR-pQCT) in patients with early rheumatoid arthritis (ERA), and what the independent effects of erosion /JSW progression are on patient's function.\n\nHypothesis to be tested: Effective control of inflammation in ERA patients who can achieve sustained SDAI remission will have less progression of joint damage then patients who cannot achieve sustained SDAI remission.\n\nDesign and subjects: 110 consecutive ERA patients will participate in this 1-year prospective, hospital-based, cohort study.\n\nStudy instruments Metacarpophalangeal joints 2-4 will be measured using HR-pQCT Interventions All participants will receive 1-year tight-control treatment according to a standardized protocol aiming at SDAI remission. Physical function will be assessed by Health Assessment Questionnaire (HAQ) at each visit. HR-pQCT and radiographs will be performed at baseline, 6 (HR-pQCT only) and 12 months. Quantitative analysis of joint space width (JSW) and volume, erosion number and volume, and marginal osteosclerosis (bone apposition at the base of the erosion) will be evaluated by HR-pQCT. Radiographic progression will be scored using van der Heijde-Sharp (SvdH) score.\n\nOutcome measures: The primary outcome is the change in JSW and volume over a period of 12 months. Main secondary outcomes include changes in the i) number and size of erosion, ii) SvdH score and iii) HAQ over a period of 12 months.\n\nExpected results: Patients who can achieve sustained SDAI remission will have less joint damage and functional loss compared"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Starting from July 2020, all new cases referrals to the rheumatology clinic of the Prince of Wales Hospital (PWH) and four other regional hospitals in Hong Kong will be screened by a research assistant. Patients referred as RA, possible RA or undifferentiated arthritis will be contacted through telephone. Patients with at least 1 tender and swollen joint and with duration of symptoms less than 2 years and with no previous use of DMARDs will be invited to a screening visit at the early arthritis clinic of the PWH within 2 weeks of the referral, where they will be formally assessed by a rheumatologist.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* fulfilled the 2010 ACR/EULAR classification criteria for RA\n* have symptoms onset of less than 2 years,\n* have active disease (SDAI \\>3.3)\n\nExclusion Criteria:\n\n* have severe clinical deformity at the 2nd, 3rd or 4th MCP joint which precluded a reliable HR-pQCT examination and resulted in motion artefacts influencing the scanning accuracy\n* are pregnant or breast feeding'}, 'identificationModule': {'nctId': 'NCT04324892', 'briefTitle': 'Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effects of Achieving SDAI Remission on Joint Space Outcomes Progression in Early Rheumatoid Arthritis: an HR-pQCT Study', 'orgStudyIdInfo': {'id': '2019.224'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treat to target', 'description': 'The study has only 1 cohort with treat-to-target strategy', 'interventionNames': ['Drug: Treat to target']}], 'interventions': [{'name': 'Treat to target', 'type': 'DRUG', 'description': 'All patient will received protocolized treatment with an aim to achieve SDAI remission', 'armGroupLabels': ['Treat to target']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Prince of Wales Hopsital', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Lai Shan Tam, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lai-Shan Tam', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}