The Effect of Gradual Withdrawal Versus Maintenance of Low-dose Glucocorticoid in Clinically Quiescent Systemic Lupus Erythematosus, a Pilot Randomized Placebo Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Any flare according any of 3 definitions
研究概览
简要总结
This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
详细描述
Glucocorticoids (GCs) remains the mainstay of treatment in SLE. Prolong used of glucocorticoid can be leading to various organ damage, even in low dose (< 7.5 mg/day). The rational of tapering GCs in SLE who achieve remission or low disease activity is still debated. Recent trial showed the abrupt discontinuation of GCs in sustained clinical remission of SLE increased rate of flare. This study aims compare the flare rate of maintenance versus gradual withdrawal of 5 mg/day prednisone over 24 weeks in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged; 20 years
- •Diagnosis of SLE according to Systemic Lupus International Collaborating Clinic (SLICC) classification SLE criteria,
- •Achieved clinically quiescent SLE defined as cSLEDAI-2K = 0 for at least 6 months.
- •Current treatment regimen including prednisolone 5mg/day. Prednisolone, antimalarials and/or immunosuppressive therapy had to be stable for at least 4 weeks before randomization.
排除标准
- •Pregnant or pregnancy planning
- •Unable to follow the schedules
- •Overlap with other autoimmune disease, except secondary SjS and APS
- •Co-morbid with any other condition which required prednisolone treatment
- •Documented adrenal insufficiency
研究组 & 干预措施
Glucocorticoid maintenance group
Maintenance of 5-mg of prednisolone daily over 24 weeks
干预措施: Glucocorticoid maintenance group (Behavioral)
Glucocorticoid withdrawal group
Gradual withdrawal of daily 5-mg prednisolone to daily 0-mg prednisolone over 20-24 weeks
干预措施: Glucocorticoid withdrawal group (Behavioral)
结局指标
主要结局
Any flare according any of 3 definitions
时间窗: 24 weeks
Flare definition: 1. Clinical SLEDAI 2K (excluding serology) ≥ 4, 2. Increase in SLE-DAS ≥ 1.72, 3. Increase in clinical SLEDAI-2K plus treatment escalation (including with NSAIDS, glucocorticoids (topical or oral), antimalarials, or immunosuppressants.
次要结局
- Changes in quality of life(24 weeks)
- Any increase in clinical SLEDAI-2K(24 weeks)
- Any changes in immunology(24 weeks)
- Any increase in damage accrual(24 weeks)