Efficacy of Micro-pulse Steroid Therapy as Induction Therapy in Patients With Polymyalgia Rheumatica
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- a total dose of glucocorticoids used in the course of the disease
研究概览
简要总结
The study will examine the efficacy of a single intramuscular injection of betamethasone dipropionate/betamethasone sodium phosphate at the dose of 20mg/8mg (injection volume 4 ml) as an induction therapy in patients with polymyalgia rheumatica. Twenty patients will be randomized to receive an injection of betamethasone or placebo (isotonic NaCl solution) immediately after diagnosis. Both groups will receive the standard-of-care steroid therapy, starting from 10 mg of prednisone every day (qd), tapered down by 2.5 mg monthly if the disease is not active (scheduled monthly follow-ups by a rheumatologist). Primary outcome measures: the total cumulative dose of glucocorticosteroids and disease duration.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinical diagnosis of polymyalgia rheumatica
排除标准
- •decompensated diabetes mellitus
- •decompensated arterial hypertension
研究组 & 干预措施
betamethasone
patients treated with a single intramuscular injection of betamethasone
干预措施: Betamethasone (Drug)
betamethasone
patients treated with a single intramuscular injection of betamethasone
干预措施: isotonic sodium chloride solution (placebo) (Drug)
isotonic sodium chloride solution
干预措施: isotonic sodium chloride solution (placebo) (Drug)
结局指标
主要结局
a total dose of glucocorticoids used in the course of the disease
时间窗: 12 months
次要结局
未报告次要终点