Rheumatoid Arthritis (RA)
Conditions
Keywords
steroid taper, adrenal insufficiency, disease activity
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.
Interventions
DRUGPrednisolone
PD will be tapered using a 5mg tab formulation
Sponsors
Seoul National University Bundang Hospital
SMG-SNU Boramae Medical Center
Gachon University Gil Medical Center
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
This study is a single-blind study without placebo control. Investigators who access the DAS28 will be blinded to the treatment
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Activity Score 28-CRP | 6 months | Disease activity: Remission \<2.6; Low 2.6-3.2; Moderate \>3.2-5.1 High \>5.1 |
Secondary
| 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 |
Contacts
Primary ContactJin Kyu Park, MD, PhD
Outcome results
None listed