Comparison of Glucocorticoid Tapering Schedules in Rheumatoid Arthritis.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 206
- 主要终点
- Disease Activity Score 28-CRP
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
This study is a single-blind study without placebo control. Investigators who access the DAS28 will be blinded to the treatment
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
5mg tablet taper
Prednisolone will be tapered using 5mg tablet formulation
干预措施: Prednisolone (Drug)
1mg tablet taper
Prednisolone will be tapered using 1 mg tablet formulation
干预措施: Prednisolone (Drug)
Continue
Prednisolone will be continued
干预措施: Prednisolone (Drug)
结局指标
主要结局
Disease Activity Score 28-CRP
时间窗: 6 months
Disease activity: Remission \<2.6; Low 2.6-3.2; Moderate \>3.2-5.1 High \>5.1
次要结局
- Number of Participants with RA flare(6 months)
- Rate of successful steroid discontinuation (%)(6 months)
- Number of adrenal insufficiency(6 months)
- Frequency of rescue medication use (%)(6 months)
研究者
Eun Bong Lee
Professor
Seoul National University Hospital