NCT07227428

Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

Type	Name	Description
DRUG	Prednisolone	PD will be tapered using a 5mg tab formulation
DRUG	Prednisolone	PD will be tapered using a 1 mg tab formulation
DRUG	Prednisolone	PD will be continued

Timeline

• Start date: 2025-12-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2025-11-12
• Last updated: 2025-11-25