Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-31 @ 12:49 PM
Study NCT ID:
NCT07227428
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-25
First Post:
2025-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D000309', 'term': 'Adrenal Insufficiency'}], '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'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'This study is a single-blind study without placebo control. Investigators who access the DAS28 will be blinded to the treatment'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 206}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-20', 'studyFirstSubmitDate': '2025-11-07', 'studyFirstSubmitQcDate': '2025-11-07', 'lastUpdatePostDateStruct': {'date': '2025-11-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Activity Score 28-CRP', 'timeFrame': '6 months', 'description': 'Disease activity: Remission \\<2.6; Low 2.6-3.2; Moderate \\>3.2-5.1 High \\>5.1'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with RA flare', 'timeFrame': '6 months'}, {'measure': 'Number of adrenal insufficiency', 'timeFrame': '6 months'}, {'measure': 'Frequency of rescue medication use (%)', 'timeFrame': '6 months'}, {'measure': 'Rate of successful steroid discontinuation (%)', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['steroid taper', 'adrenal insufficiency', 'disease activity'], 'conditions': ['Rheumatoid Arthritis (RA)']}, 'descriptionModule': {'briefSummary': 'This multicenter, randomized, controlled, single-blind prospective study aims to establish an evidence-based protocol for discontinuing long-term low-dose glucocorticoids in patients with rheumatoid arthritis (RA). The study will compare two tapering strategies (1) a split-dose tapering method, in which the 5 mg tablet is divided into halves and gradually reduced, and (2) a sequential 1 mg-by-1 mg tapering method.\n\nA total of 206 patients (including 50 from Seoul National University Hospital) will be enrolled and followed for six months. Participants will be randomly assigned to one of the two tapering arms, and an exploratory group will include patients who continue low-dose prednisolone without tapering.\n\nThe primary efficacy endpoint is the change in RA disease activity, measured by DAS28-CRP, to demonstrate non-inferiority between the two tapering strategies. Secondary endpoints include the success rate of glucocorticoid discontinuation and changes in disease activity over time.\n\nThis trial seeks to define a standardized, practical glucocorticoid tapering protocol tailored to Korean RA patients. The findings are expected to support safer steroid withdrawal, reduce treatment-related adverse events, and guide clinical decision-making in long-term management of rheumatoid arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males or females ≥19 years of age at time of consent\n* Body weight \\< 90kg\n* Have a diagnosis of RA per the 2010 ACR/EULAR criteria for at least 6 months\n* Disease activity of rheumatoid arthritis has been stable for at least 4 weeks prior to randomization (DAS28-CRP ≤ 3.2)\n* The patient has been taking a stable dose of prednisolone equivalent ≤ 5 mg/day for at least 12 weeks prior to randomization\n* The dose of corticosteroids has not changed during the 4 weeks prior to randomization\n\nExclusion Criteria:\n\n* History of major surgery within 8 weeks prior to screening\n* Increase in the dose of antirheumatic drugs within 4 weeks prior to screening due to worsening arthritis\n* Pregnant or breastfeeding\n* RA functional class IV, requiring confinement to bed or wheelchair\n* History of primary or secondary adrenal insufficiency'}, 'identificationModule': {'nctId': 'NCT07227428', 'briefTitle': 'Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.', 'orgStudyIdInfo': {'id': '2502-080-1613'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '5mg tablet taper', 'description': 'Prednisolone will be tapered using 5mg tablet formulation', 'interventionNames': ['Drug: Prednisolone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '1mg tablet taper', 'description': 'Prednisolone will be tapered using 1 mg tablet formulation', 'interventionNames': ['Drug: Prednisolone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Continue', 'description': 'Prednisolone will be continued', 'interventionNames': ['Drug: Prednisolone']}], 'interventions': [{'name': 'Prednisolone', 'type': 'DRUG', 'description': 'PD will be tapered using a 5mg tab formulation', 'armGroupLabels': ['5mg tablet taper']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'PD will be tapered using a 1 mg tab formulation', 'armGroupLabels': ['1mg tablet taper']}, {'name': 'Prednisolone', 'type': 'DRUG', 'description': 'PD will be continued', 'armGroupLabels': ['Continue']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jin Kyu Park, MD, PhD', 'role': 'CONTACT', 'email': 'jinkyunpark@snu.ac.kr', 'phone': '82-2-2072-4765'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'Gachon University Gil Medical Center', 'class': 'OTHER'}, {'name': 'Chung-Ang University Hosptial, Chung-Ang University College of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Bong Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}