Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

Seoul National University

Status and phase: Not yet enrolling; Phase 4

Conditions: Rheumatoid Arthritis (RA)

Treatments: Drug: Prednisolone

Study type: Interventional

Funder types: Other

Identifiers

NCT07227428

2502-080-1613

Details and patient eligibility

About

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.

Enrollment: 206 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 3 patient groups, including a placebo group

5mg tablet taper

Experimental group

Description:

Prednisolone will be tapered using 5mg tablet formulation

Treatment:

Drug: Prednisolone

Drug: Prednisolone

Drug: Prednisolone

1mg tablet taper

Active Comparator group

Description:

Prednisolone will be tapered using 1 mg tablet formulation

Treatment:

Drug: Prednisolone

Drug: Prednisolone

Drug: Prednisolone

Continue

Placebo Comparator group

Description:

Prednisolone will be continued

Treatment:

Drug: Prednisolone

Drug: Prednisolone

Drug: Prednisolone