Short Term Study on the Effect of a Fixed Dose of 12.5 mg of Prednisone as Starting Dose in Polymyalgia Rheumatica
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- clinical remission within one month from the treatment initiation
研究概览
简要总结
Polymyalgia rheumatica (PMR) is a common inflammatory condition affecting elderly people and involving the girdles. The mainstay of treatment is oral glucocorticoids (GC), with the recent BSR-BHPR guidelines suggesting an initial prednisone dose comprised between 15 and 20 mg as appropriate. However, probably because of the dramatic response of PMR to GC, randomized controlled trials of treatment are lacking. As a result, there is no evidence from controlled studies on the efficacy of different initial doses or drug tapering. Objective of the study: to test if 12.5 mg prednisone/day is an adequate starting dose in polymyalgia rheumatica (PMR) and to evaluate clinical predictors of drug response.
Methods: 60 consecutive PMR patients will be treated with a starting dose of 12,5 mg/day prednisone. Clinical, laboratory, and ultrasonographic features will be recorded as possible predictors of response to prednisone. Remission is defined as disappearance of at least 75% of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, a scenario allowing steroid tapering.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with PMR, diagnosed according to the criteria of Bird et al
排除标准
- •patients with arthritis
- •patients with giant cell arteritis
- •patients with Parkinson's disease
- •patients with hypothyroidism
- •patients with scapulohumeral periarthritis
- •patients with fibromyalgia
- •patients unable to cooperate
结局指标
主要结局
clinical remission within one month from the treatment initiation
时间窗: 1 month
Remission was defined as at least a 70% global improvement of the signs and symptoms of PMR and normalization of ESR and CRP within the first month, allowing steroid tapering.
次要结局
- to evaluate demographic features as possible predictive factors of response to 12.5 mg of prednisone(1 month)
- to evaluate characteristics of PMR as predictive factors of response to 12.5 mg of prednisone(1 month)
- to evaluate findings at clinical examination as predictive factors of response to 12.5 mg of prednisone(1 month)
- to evaluate laboratory parameters as predictive factors of response to 12.5 mg of prednisone(1 month)
- to evaluate results of US as possible predictors of response to 12.5 mg prednisone(1 month)