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Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

StatusNot Yet Recruiting
PhasePhase 4
Started
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Record History

  1. Primary endpoint revised Secondary endpoints revised (4)v3 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  2. Primary endpoint revised Secondary endpoints revised (4)v2 Show 1 more changeShow less
    • Secondary endpoints revised (4)

    See this version in full on ClinicalTrials.gov ↗

  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07227428
Lead Sponsor Seoul National University Hospital
Collaborators: Seoul National University Bundang Hospital, SMG-SNU Boramae Medical Center, Gachon University Gil Medical Center, Chung-Ang University Hospital
Conditions Rheumatoid Arthritis (RA)
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov