Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis
Status:
NOT_YET_RECRUITING
Trial end date:
2027-12-31
Target enrollment:
Participant gender:
Summary
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.
A 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.
The 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.
This 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.
Phase:
PHASE4
Details
Lead Sponsor:
Seoul National University Hospital
Collaborators:
Chung-Ang University Hosptial, Chung-Ang University College of Medicine Gachon University Gil Medical Center Seoul National University Bundang Hospital SMG-SNU Boramae Medical Center