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Not yet recruiting NCT07227428

Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis

Phase IV Interventional Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Prednisolone, Prednisolone, Prednisolone.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Disease Activity Score 28-CRP [Time frame: 6 months]
Secondary outcome measures (4)
  • Number of Participants with RA flare [Time frame: 6 months]
  • Number of adrenal insufficiency [Time frame: 6 months]
  • Frequency of rescue medication use (%) [Time frame: 6 months]
  • Rate of successful steroid discontinuation (%) [Time frame: 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07227428 · 2502-080-1613

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗