Disease Activity Monitoring in Patients With Giant Cell Arteritis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 175
- 试验地点
- 10
- 主要终点
- Sensitivity and specificity of change in OGUS from inclusion to suspected relapse
研究概览
简要总结
Giant Cell Arteritis (GCA) is a vasculitis of medium- and large-sized arteries in older adults that may lead to serious vascular complications, including permanent vision loss and aortic aneurysm formation. Glucocorticoids are effective, but relapse during tapering is common and poses a major clinical challenge, potentially contributing to prolonged glucocorticoid exposure. Symptoms are often nonspecific and conventional inflammatory markers lack sufficient reliability, particularly in patients treated with drugs targeting the interleukin-6 pathway. Thus, this project aims to evaluate different tools assisting disease activity monitoring and/or predict future relapses and higher treatment requirements. Up to 175 patients with GCA in remission will be enrolled to ensure that 144 participants complete 1 year of follow-up. Participants undergo vascular ultrasonography, including double-blinded assessment at suspected relapse, complete patient-reported outcome measures, and provide biobank blood samples.
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
- •Clinical GCA diagnosis established/confirmed by a rheumatologist and positive GCA imaging or biopsy at diagnosis < 3 years.
- •Clinical remission at the time of inclusion, defined as
- •Having adhered for ≥ 8 weeks prior to inclusion to either (a) the planned tapering of glucocorticoid therapy, or (b) the planned glucocorticoid-sparing DMARD treatment (with or without glucocorticoids).
- •Absence of, or no worsening of, symptoms attributed to GCA in ≥ 8 weeks.
- •Normal CRP level (< 10 mg/L) within 7 days before inclusion.
- •Current prednisolone dosage of ≥ 5 mg if glucocorticoid monotherapy.
- •A continuous tapering of monotherapy or combination therapy is planned.
- •Age > 50 years.
- •Study participants must be able to speak and understand spoken and written Danish.
排除标准
- •Intra-articular, intravenous or intramuscular glucocorticoid ≤ 7 weeks prior to inclusion.
- •Study participants who are unable to complete online questionnaires cannot participate in the GCA-PRO component of the study.
- •Presence of cognitive impairment, including clinically significant dementia, that may interfere with the ability to provide informed consent or comply with study procedures.
结局指标
主要结局
Sensitivity and specificity of change in OGUS from inclusion to suspected relapse
时间窗: Within 10 months
Sensitivity and specificity of change in OMERACT Ultrasonography GCA Score (OGUS) from inclusion to suspected relapse (Follow-up 1a) for relapse/non-relapse using the reassessment at Follow-up 2 as the reference standard.
次要结局
- Proportion of correctly classified relapse/non-relapse by vascular ultrasonography among participants with clinically uncertain relapse(Within 10 months)
- Predictive cut-off values of vascular ultrasonography scores at remission for relapse(12 months)
- Change in GCA-PRO scores from remission to relapse(Within 10 months)
- Sensitivity and specificity of change in halo count from inclusion to suspected relapse(Within 10 months)
- Sensitivity and specificity of vascular ultrasonography scores at suspected relapse(Within 10 months)
- Sensitivity and specificity of vascular ultrasonography scores for relapse/non-relapse in subgroups defined by OMERACT ultrasonography morphology(Within 10 months)
- Change in probability of relapse and non-relapse before and after vascular ultrasonography(Within 10 months)
- Time from suspected relapse to clinical conclusion in participants with clinically uncertain relapse that were correctly classified with vascular ultrasonography(12 months)
- Number of supplementary tests ordered at suspected relapse to clinical conclusion in participants with clinically uncertain relapses/non-relapse that were correctly classified by vascular ultrasonography(12 months)
- Time to relapse over 12 months in relation to vascular ultrasonography scores at inclusion(12 months)
- Change in GCA-PRO scores at relapse and 10 days after treatment escalation.(Within 10 months)
- Convergence of GCA-PRO scores with other surrogate markers of disease activity from remission to relapse(Within 10 months)
- Sensitivity and specificity of change in GCA-PRO scores from inclusion to suspected relapse(Within 10 months)
- Sensitivity and specificity of GCA-PRO scores at suspected relapse(Within 10 months)
- Relapse within 12 months evaluated in relation to GCA-PRO scores at inclusion.(12 months)
- Time to relapse over 12 months evaluated in relation to GCA-PRO scores at inclusion.(12 months)