Takayasu's Arteritis Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Rate of Clinical Remission at 12 Months
研究概览
简要总结
Takayasu's Arteritis Global Registry aims to bring a large group of patients from different parts of the world to analyse and compare the patients' demographic, clinical, laboratory, radiological and prognostic features with outcomes, approaches to diagnosis, assessment, management and therapeutic interventions in different centers. The present project provides for both a retrospective and a prospective longitudinal study. The study is designed as retrospective for patients already diagnosed with TAK and treated with available treatments. Also, the study is designed as prospective for patients diagnosed with TAK after the initiation of the Registry or the adhesion to the project. This is thought as a multicentre, international study addressed to all Centers that will want to contribute to the present project. The study is non-interventional: demographic, clinical and therapeutic data required over time are collected with the routine diagnostic, clinical and therapeutic procedures usually carried out for the optimal management of patients and according with good clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each patient must fullfill the ACR 1990 or ACR/EULAR 2021 criteria for Takayasu arteritis.
- •Patients (or legally acceptable representatives of subjects enrolled) have to
- •provide informed and free agreement to participate in the study and to disclose any medical event to the investigator. The parents or legally acceptable representative and the adolescent subject must be willing and able to comply with the study protocol requirements for the duration of the study
- •freely sign written and dated informed consent after being duly informed of the nature, significance, and implications of the study;
- •be informed that the patient enrolled may withdraw consent at any time without prejudice to future medical care.
排除标准
- •Patients must be excluded from the study when the following criteria are observed:
- •The patient does not full-fill the ACR 1990 or ACR/EULAR 2021 criteria for Takayasu arteritis
- •informed consent/assent is not provided and signed
研究组 & 干预措施
Takayasu's arteritis
This prospective observational, multi-centre, multi-national cohort study aims to comprehensively collect and analyse the demographic, clinical, laboratory, and radiological data of patients with TAK. By doing so, the TAK Registry will enable the investigation of key outcomes, including disease activity, relapse and mortality and associated factors, ultimately contributing to a better understanding and management of TAK.
结局指标
主要结局
Rate of Clinical Remission at 12 Months
时间窗: 120th month from the start of the study
Clinical remission will be defined according to the absence of clinical signs and symptoms of active disease and normalization of inflammatory markers
次要结局
- Incidence of Disease Relapse During Follow-up(From baseline through study completion (up to 120 months))
- Frequency of Long-term Complications During Follow-up(120 months)
- Change in damage during follow-up(From baseline through study completion (up to 120 months))
- Rate of radiographic progression(From baseline through study completion (up to 120 months))
研究者
Fatma Alibaz Oner
Professor, MD
Marmara University