Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rheumatoid Arthritis (RA)
• Intervention / Treatment: Drug: Prednisolone; Drug: Prednisolone; Drug: Prednisolone

• Study Type: Interventional
• Enrollment (Estimated): 206
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jin Kyu Park, MD, PhD; Phone Number: 82-2-2072-4765; Email: jinkyunpark@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 5mg tablet taper; Prednisolone will be tapered using 5mg tablet formulation	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
Active Comparator: 1mg tablet taper; Prednisolone will be tapered using 1 mg tablet formulation	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
Placebo Comparator: Continue; Prednisolone will be continued	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease Activity Score 28-CRP	Disease activity: Remission <2.6; Low 2.6-3.2; Moderate >3.2-5.1 High >5.1	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of Participants with RA flare	6 months
Number of adrenal insufficiency	6 months
Frequency of rescue medication use (%)	6 months
Rate of successful steroid discontinuation (%)	6 months

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Seoul National University Bundang Hospital; Gachon University Gil Medical Center; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; SMG-SNU Boramae Medical Center

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 7, 2025
• First Submitted That Met QC Criteria: November 7, 2025
• First Posted (Estimated): November 12, 2025

Study Record Updates

• Last Update Posted (Actual): November 25, 2025
• Last Update Submitted That Met QC Criteria: November 20, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: disease activity; adrenal insufficiency; steroid taper
• Additional Relevant MeSH Terms: Endocrine System Diseases; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Adrenal Gland Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Adrenal Insufficiency; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienetriols; Prednisolone
• Other Study ID Numbers: 2502-080-1613

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No