Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

NCT07227428 | Not Yet Recruiting Phase 4

• 1 other identifier: 2502-080-1613
• Study Type: interventional
• Target: 206
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Rheumatoid Arthritis (RA)

Keywords

steroid taper; adrenal insufficiency; disease activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (3)

5mg tablet taper

EXPERIMENTAL

Prednisolone will be tapered using 5mg tablet formulation

Drug: Prednisolone

1mg tablet taper

ACTIVE COMPARATOR

Prednisolone will be tapered using 1 mg tablet formulation

Drug: Prednisolone

Continue

PLACEBO COMPARATOR

Prednisolone will be continued

Drug: Prednisolone

Interventions

Prednisolone DRUG

PD will be tapered using a 5mg tab formulation

5mg tablet taper

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

MeSH Terms

Conditions

Arthritis, Rheumatoid; Adrenal Insufficiency

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Adrenal Gland Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Central Study Contacts

Jin Kyu Park, MD, PhD

CONTACT

82-2-2072-4765; jinkyunpark@snu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: This study is a single-blind study without placebo control. Investigators who access the DAS28 will be blinded to the treatment
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 25, 2025

Record last verified: 2025-11