Disease Stratification in GCA and PMR to Inform Management and Reduce Disease and Treatment-related Damage
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 3,000
- 试验地点
- 2
- 主要终点
- Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
研究概览
简要总结
The aim of this national pragmatic observational study is to investigate whether the use of new diagnostic imaging modalities facilitates disease stratification that can potentially predict treatment response, relapse risk and complications and hence guide management strategies to improve disease control and reduce disease and treatment related damage.
详细描述
BACKGROUND Giant cell arteritis (GCA) is the most common vasculitis of the elderly. The concomitant disease polymyalgia rheumatica (PMR) is characterised by pain of the proximal muscles, general symptoms, and raised inflammatory markers. Only limited research has previously been performed nationally and internationally in GCA and PMR. To explore clinical practice, biomarkers, disease subsets, comorbidities, and long-term effectiveness of new treatments the establishment of large registries are highly warranted.
OBJECTIVES Primary objective: To compare cumulative GC doses in patients with c-GCA as compared to Large vessel (LV) -GCA
Key secondary objectives:
- To compare cumulative GC doses in patients with pure PMR compared to PMR patients with subclinical LV-GCA
- To compare the incidence of aortic dilatation 2 years after diagnosis in patients with c-GCA as compared to LV-GCA
- In the subpopulation of patients whom a diagnostic Fluor-Deoxy-Glucose Positron Emissions Tomography ( FDG- PET)/CT was performed, to evaluate the risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.
Once the database is established nationally, the database will be the basis for additional research projects in the future.
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
- •Are diagnosed with GCA or PMR within the last 5 years
- •Diagnosis is established by or confirmed by a rheumatologist (clinical expert opinion)
- •Speak and understand Danish
- •Are able to give signed and dated informed consent
排除标准
- •Denies or are not able to give informed consent
- •Are diagnosed with other systemic autoimmune diseases that out-rules the diagnosis of GCA or PMR
结局指标
主要结局
Cumulative glucocorticoid doses compared between patients with cranial GCA and patients with Large Vessel-GCA
时间窗: From date of diagnosis with GCA until one year after. Assessed yearly up to 120 months
based on redeemed prescriptions
次要结局
- Risk of aortic complications (aneurisms and dissections) in GCA patients with aortic involvement as compared to patients without aortic involvement.(2 years after diagnosis)
- Comparison of cumulative glucocorticoid doses in patients with pure PMR compared to PMR with subclinical LV-GCA(From date of diagnosis with PMR until one year after. Assessed yearly up to 120 months)
- Incidence of aortic dilatation in patients with c-GCA as compared to LV-GCA(2 years after diagnosis)