The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Polymyalgia rheumatica activity score (PMR-AS)
研究概览
简要总结
The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR).
PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR.
The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Persons with active polymyalgia rheumatica (patients only).
- •Signed informed consent and written authorization.
排除标准
- •Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances.
- •Current malignancy or history of malignancy.
- •Neuromuscular conditions.
- •Infections with systemic impact.
- •Uncontrolled diabetes mellitus.
- •Uncontrolled hypertension.
- •Current tuberculosis or history of tuberculosis.
- •Severe heart failure (NYHA class 3 and 4).
- •Current use of glucocorticoids, biological drugs, and immunosuppressive drugs.
- •Exclusion Criteria (controls):
- •Polymyalgia rheumatica.
研究组 & 干预措施
未命名试验
干预措施: Sodium chloride (placebo) (Drug)
未命名试验
干预措施: Etanercept (Enbrel) (Drug)
结局指标
主要结局
Polymyalgia rheumatica activity score (PMR-AS)
时间窗: 14 days
次要结局
- Plasma concentrations of various cytokines, chemokines, and adipokines(14 days)
- Quantitative use of analgesics(14 days)
- Insulin sensitivity (HOMA)(14 days)