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NCT Number: NCT07227428

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Adrenal Gland Diseases Adrenal Insufficiency Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Endocrine System Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prednisolone

Drug

PD will be tapered using a 5mg tab formulation

Primary outcomes

  1. Disease Activity Score 28-CRP

    Time frame: 6 months

    Disease activity: Remission <2.6; Low 2.6-3.2; Moderate >3.2-5.1 High >5.1

Secondary outcomes

  1. Number of Participants with RA flare

    Time frame: 6 months

  2. Number of adrenal insufficiency

    Time frame: 6 months

  3. Frequency of rescue medication use (%)

    Time frame: 6 months

  4. Rate of successful steroid discontinuation (%)

    Time frame: 6 months

Study contacts

Contact information is provided by the study sponsor or research team.

Jin Kyu Park, MD, PhD

CONTACT

[email protected]

82-2-2072-4765

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Chung-Ang University Hospital
  • Gachon University Gil Medical Center
  • SMG-SNU Boramae Medical Center
  • Seoul National University Bundang Hospital

Registry information

Official study title

Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 12, 2025
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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