A Multicenter Prospective Observational Study on the Role of the OMERACT Takayasu Ultrasound Score (OTUS) in Monitoring Disease Activity in Patients With Takayasu Arteritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- To evaluate whether the OTUS score, an OMERACT-derived vascular ultrasound score, is sensitive to change between clinically active disease and remission in patients with TAK.
研究概览
简要总结
This is a multicenter prospective observational study aimed at evaluating the role of an ultrasonographic score in monitoring disease activity in patients with Takayasu arteritis (TAK). Patients with active disease, either at new diagnosis or during relapse, will undergo serial vascular US assessments during follow-up according to routine clinical practice at each participating centers. For each patient, an OMERACT-derived US score (OTUS) will be calculated. This score was developed and preliminarily validated in previous phases of a multistep project endorsed by OMERACT (Outcome Measures in Rheumatology), an international initiative focused on the development and validation of outcome measures in rheumatology. The study hypothesis is that this score is sensitive to change over time and can be used to monitor disease activity and predict outcome in patients with TAK.
详细描述
This is an observational study. The study concerns a diagnostic procedure (vascular US) that is part of normal clinical practice for patients with large-vessel vasculitis (LVV). The decision to perform vascular US in patients with TAK will remain independent from the decision to enroll the patient in the study. No investigational medicinal product or experimental device is involved. The procedure under study is an ultrasonographic scoring system derived from vascular US examinations of selected arterial segments in patients with TAK. Examinations will be performed according to standardized OMERACT protocols, including assessment of the common carotid, subclavian and axillary arteries, and the abdominal aorta. For each patient, an OMERACT-derived OTUS score will be calculated at each assessment. No comparator is mandated; however, clinical disease activity state and results from other imaging modalities (FDG-PET, MRA, CTA), when available as part of routine clinical care, will be collected for exploratory analyses. Study participation will last 24 months, during which patients will undergo serial US examinations at predefined follow-up visits as part of routine clinical monitoring. Vascular US is a non-invasive, radiation-free and contrast-free technique, already employed in standard clinical care and used here exclusively for observational purposes.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Male and female
- •Diagnosis of TAK according to the 1990 ACR and/or 2022 ACR/EULAR classification criteria
- •Active disease, defined as the presence of at least two of the following three domains:
- •Clinical domain: new onset or worsening of clinical signs and/or symptoms attributable to TAK;
- •Laboratory domain: elevation of inflammatory markers, defined as ESR and/or CRP above the upper limit of normal according to local laboratory standards, not attributable to causes other than TAK;
- •Imaging domain: imaging evidence of active vasculitis on modalities other than ultrasound, including FDG-PET, magnetic resonance angiography (MRA), or computed tomography angiography (CTA).
- •Ability to undergo serial vascular ultrasound assessments during follow-up
- •Provision of signed informed consent
排除标准
- •Inability or contraindication to undergo vascular US
- •Severe comorbidities limiting participation or follow-up
- •Concomitant conditions that may confound ultrasound findings (e.g., significant atherosclerosis requiring intervention, complete occlusion of one of the arterial segments under investigation)
- •Diagnosis of another rheumatologic disease
- •Refusal or inability to provide informed consent
结局指标
主要结局
To evaluate whether the OTUS score, an OMERACT-derived vascular ultrasound score, is sensitive to change between clinically active disease and remission in patients with TAK.
时间窗: US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24. For the primary endpoint only baseline → first remission visit will be analyzed.
Change in OTUS from baseline (active disease) to the first visit in which remission is achieved according to the treating physician (blinded to US results).
次要结局
- To assess the correlation between OTUS changes and clinical/laboratory markers of disease activity.(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- To evaluate the agreement between OTUS-based activity assessment and Physician Global Assessment (PGA)(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- To evaluate the agreement between OTUS-based activity assessment and NIH disease activity score(Baseline, month 1, month 3, month 6, month 12, month 18, month 24)
- Hazard ratio for time to relapse per unit increase in baseline OTUS score(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- Hazard ratio for time to vascular damage progression per unit increase in baseline OTUS score(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- To assess the diagnostic ability of OTUS to detect clinical relapse during follow-up.(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- Odds ratio for successful glucocorticoid discontinuation per unit increase in baseline OTUS score(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- Hazard ratio for time to relapse per unit increase in OTUS change from baseline to month 3(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- Hazard ratio for time to vascular damage progression per unit increase in OTUS change from baseline to month 3(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- Odds ratio for successful glucocorticoid discontinuation per unit increase in OTUS change from baseline to month 3(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- Absolute OTUS score in treatment responders vs non-responders(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
- OTUS change from baseline (ΔOTUS) in treatment responders vs non-responders(US performed at baseline, month 1, month 3, month 6, month 12, month 18, month 24.)
研究者
Tomelleri Alessandro
Consultant
IRCCS San Raffaele