Prospective, International, Multi-centre Study on ASAS Classification Criteria for SpA
试验速览
- 阶段
- 不适用
- 入组人数
- 992
- 试验地点
- 34
- 主要终点
- Diagnosis of Spondyloarthritis
研究概览
简要总结
Background:
Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.
Aims of the study:
- To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
- To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
- To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.
详细描述
Background:
Existing criteria for AS/SpA such as mod. New York, ESSG, or Amor criteria for classification and/or diagnosis of spondyloarthritis have limitations when applied to early disease. Moreover, MRI is not part of any of the established criteria and the precise role of MRI in early axial disease has not been fully defined yet. Even less is known about sacroiliac (SI) changes in SpA patients with peripheral symptoms. A pilot study using data from 'paper patients' led to new candidate criteria for early spondyloarthritis. Subsequently, the members of the ASAS International Working Group decided to conduct a prospective multi-centre study to evaluate (validate) the new candidate criteria, and to assess their performance as diagnostic criteria.
Aims of the study:
- To evaluate the new candidate criteria for axial SpA in a multi-centre setting.
- To assess the potential role of the new candidate criteria to be used as diagnostic criteria. To accomplish this, inclusion of consecutive and undiagnosed patients is mandatory as are longer periods of follow-up .
- To compare criteria encompassing the whole group of SpA such as ESSG and Amor criteria against criteria which are tailored to either predominant axial disease or predominant peripheral disease. To accomplish this, both patients with predominant axial disease (back pain) but also patient with predominant peripheral disease (arthritis/enthesitis) will be included.
Participating centres:
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
- •Include newly referred patients if:
- •Onset of symptoms (back pain/arthritis/enthesitis) < 45 years
- •Undiagnosed disease with the following symptoms:
- •chronic back pain (duration of back pain more than 3 months)
- •and/or peripheral arthritis (asymmetric arthritis/predominantly of the lower limbs)
- •and/or enthesitis
- •and/or dactylitis
排除标准
- •No symptoms such as specified in inclusion criteria: back pain, arthritis, enthesitis
- •Definite diagnosis
结局指标
主要结局
Diagnosis of Spondyloarthritis
时间窗: 2 years
次要结局
- Patients with a retained diagnosis of spondyloarthritis after follow-up(2-5 years)
研究者
J. Sieper
Prof.
Charite University, Berlin, Germany