Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

Not Applicable

Not yet recruiting

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Drug: Prednisolone

• Registration Number: NCT07227428
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-07
• Study First Submitted QC: 2025-11-07
• Last Update Submitted: 2025-11-07
• Study First Posted: 2025-11-12
• Last Update Posted: 2025-11-12
• Study Start: 2025-12-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

• Males or females ≥19 years of age at time of consent
• Body weight < 90kg
• Have a diagnosis of RA per the 2010 ACR/EULAR criteria for at least 6 months
• Disease activity of rheumatoid arthritis has been stable for at least 4 weeks prior to randomization (DAS28-CRP ≤ 3.2)
• The patient has been taking a stable dose of prednisolone equivalent ≤ 5 mg/day for at least 12 weeks prior to randomization
• The dose of corticosteroids has not changed during the 4 weeks prior to randomization

Exclusion Criteria

• History of major surgery within 8 weeks prior to screening
• Increase in the dose of antirheumatic drugs within 4 weeks prior to screening due to worsening arthritis
• Pregnant or breastfeeding
• RA functional class IV, requiring confinement to bed or wheelchair
• History of primary or secondary adrenal insufficiency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5mg tablet taper	Prednisolone	Prednisolone will be tapered using 5mg tablet formulation
1mg tablet taper	Prednisolone	Prednisolone will be tapered using 1 mg tablet formulation
Continue	Prednisolone	Prednisolone will be continued

Primary Outcome Measures

Name	Time	Method
DAS28-CRP	6 months

Secondary Outcome Measures

Name	Time	Method
RA flare	6 months
occurrence of adrenal insufficiency	6 months
frequency of rescue medication use	6 months
rate of successful steroid discontinuation	6 months