Dose Reduction and Discontinuation of Prednisolone Using Structured Treat-to-target Taper in Patients With Polymyalgia Rheumatica
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
- 试验地点
- 11
- 主要终点
- Proportion of patients in prednisolone free remission 52 weeks from baseline
研究概览
简要总结
Polymyalgia rheumatica (PMR) has an incidence of approximately 1000/10^6 for persons more than 50 years. Treatment with prednisolone carries several significant adverse effects, and it is therefore essential to taper prednisolone as fast as possible. Systematic treatment strategies (treat-to-target) is the most important improvement of disease management for other rheumatic diseases such as rheumatoid arthritis in the last decades. Thus, the purpose is to investigate benefits and harms associated with a nurce led systematic prednisolone taper strategy at the department of rheumatology compared to individual treatment by discretion of the general practitioner. It is a 1-year open label randomised trial with a 1-year extension in 120 treatment naïve patients with PMR.
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
- 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 newly diagnosed with PMR according to the EULAR criteria for PMR.
- •No sign of GCA on ultrasonography of the temporal and axillary arteries.
- •Age over 50 years.
- •Danish spoken and written language skills sufficient to fill out questionnaires.
排除标准
- •Peroral, intraarticular or intramuscular application of glucocorticoids within the last month.
- •Previous prednisolone treatment for GCA/PMR.
- •Unable to give consent.
- •Symptoms of GCA (newly onset-headache, tenderness of the temporal artery, jaw claudication, vision disturbances).
- •Active malignant cancers within the last 5 years (except basal cell carcinoma).
- •Other inflammatory rheumatic diseases (eg. rheumatoid arthritis, polymyositis, spondyloarthritis, psoriatic arthritits, gout).
- •Uncontrolled diseases (eg severe active asthma, cardiac disease with NYHA class IV)
结局指标
主要结局
Proportion of patients in prednisolone free remission 52 weeks from baseline
时间窗: 52 weeks
Proportion of patients in prednisolone free remission 52 weeks from baseline
次要结局
- Change in prednisolone dose from baseline to week 52(52 weeks)
- Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52 Proportion of patients with an undiagnosed vasculitis assessed by ultrasound at week 52(52 weeks)
- Changes in patient reported stiffness visual analog scale (VAS) from baseline to week 52(52 weeks)
- Change in patient-reported global visual analogue scale (VAS) from baseline to week 52(52 weeks)
- Changes in health assessment questionnaire disability index (HAQ-DI) from baseline to week 52(52 weeks)
- Proportion of GCA patients diagnosed during the first 52 weeks(52 weeks)
- Self-reported number of relapses during the first 52 weeks(52 weeks)
- Change in polymyalgia rheumatica activity score (PMR-AS) from baseline to week 52(52 weeks)
- Changes in short form (SF)-36 physical component summary (PCS) from baseline to week 52(52 weeks)
- Changes in patient reported polymyalgia rheumatica visual analog scale (PMR VAS) from baseline to week 52(52 weeks)
- Changes in patient reported duration of morning stiffness from baseline to week 52(52 weeks)
- Changes in patient reported fatigue visal analog scale (VAS) from baseline to week 52(52 weeks)
- Proportion of patients with patient reported infections during the first 52 weeks(52 weeks)
- Changes in short form (SF)-36 mental component summary (MCS) from baseline to week 52(52 weeks)
- Frequency of patient reported adverse effects and comorbidities related to prednisolone treatment after 13, 26, 39 and 52 weeks(52 weeks)
- Proportion of patients where baseline DXA scan are performed during the first 3 months after baseline visit(3 months)
- Proportion of patients where HgbA1C blood samples are taken during the first 52 weeks(52 weeks)
研究者
Kresten Krarup Keller
MD associate professor
Aarhus University Hospital