Improved Diagnostics and Monitoring of 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
- 98
- 试验地点
- 3
- 主要终点
- PMR diagnosis at baseline with PET/CT
研究概览
简要总结
Background: Polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Treatment with prednisolone has several adverse effects. PMR is an exclusion diagnosis, and methods to diagnose and monitor the disease are lacking.
Objective: To investigate if ultrasound and PET/CT can be used to diagnose and monitor PMR. In addition, the importance of prednisolone induced adrenal insufficiency is investigated.
Methods: It is a prospective observational study in patients suspected of PMR. Patients diagnosed with PMR continue in the study. Ultrasound and PET/CT are performed at baseline, after 8 weeks on prednisolone, and after 10 weeks during a short prednisolone break. Adrenal insufficiency is investigated five times throughout the study. After one year the PMR diagnosis is confirmed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 suspected of PMR.
- •Age above 50
- •Pain of the proximal muscles.
排除标准
- •Peroral, intraarticular, intramuscular and dermal application of glucocorticoids within the last 3 month.
- •Previous prednisolone treatment for GCA/PMR
- •Unable to give consent.
- •Symptoms of GCA (headache, 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 astma, cardiac disease with NYHA class IV)
- •Treatment with peroral oestrogens, aminogluthethimid, trilostan, ketoconazole, fluconazol, etomidate, phenobarbital, phenytoin, rifampicin, metyrapon, mitotane.
- •Known primary or secondary adrenal insufficiency.
结局指标
主要结局
PMR diagnosis at baseline with PET/CT
时间窗: Baseline
Sensitivity and specificity of PET/CT for PMR diagnosis at baseline with the clinical diagnosis after 1 year as reference standard and patients not diagnosed with PMR serving as controls.
次要结局
- Change in expression levels of clock gene mRNA as marker of prednisolone-induced changes in sleep, lipid levels and glycated hemoglobin.(1 year)
- Percentage of patients receiving prednisolone after 3 and 5 years.(5 Years)
- PET/CT measures at baseline as a predictor of prednisolone treatment after 3 and 5 years.(5 Years)
- Change in PET/CT parameters from baseline to week(8 weeks)
- Presence of adrenal insufficiency at week 10 as a predictor of prednisolone cessation at one year.(12 months)
- Change in clinical parameters week 10.(10 weeks)
- Change in PROM's from week 8 to week 10.(10 weeks)
- Sensitivity and specificity of CRP for PMR diagnosis at week 10.(10 weeks)
- Level of inflammatory markers in PMR patients at baseline vs. week 8.(8 weeks)
- PMR diagnosis at week 8 with PET/CT(8 weeks)
- Frequency of adrenal insufficiency at week 10.(10 weeks)
- Change in PROM's from baseline to week 8.(8 weeks)
- Change in PROM's from baseline to 1 year.(12 months)
- Adrenal insufficiency as a predictor of prednisolone treatment after 3 and 5 years.(5 Years)
- Changes in US findings from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years(5 Years)
- Change in Ultrasound parameters from baseline to week 8(8 weeks)
- Change in PET/CT parameters from week 8 to week 10.(10 weeks)
- Frequency of adrenal insufficiency(18 months)
- Change in clinical parameters week 8.(8 weeks)
- Frequency of GCA(12 months)
- Level of inflammatory markers in PMR patients vs. non PMR patients at baseline.(Baseline)
- Changes in PET/CT parameters from baseline to week 8 as predictor of prednisolone treatment after 3 and 5 years(5 Years)
- PMR diagnosis at week 10 with PET/CT(10 weeks)
- Change in Ultrasound parameters from week 8 to week 10(10 weeks)
- Lean boyd weight(18 months)
- Hypercortisolism as predictor of adrenal insufficiency.(18 months)
- Percentage of patients with concomitant GCA and PMR after 3 and 5 years.(5 Years)
- Presence of adrenal insufficiency at week 10 as a predictor of relapse at week 10.(10 weeks)
研究者
Kresten Krarup Keller
MD, PhD
Central Jutland Regional Hospital