Chinese Spondyloarthritis Inception Cohort
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,000
- 主要终点
- CRP
研究概览
简要总结
The Chinese Spondyloarthritis Inception cohort (CESPIC) was started 2000 as a prospective, longitudinal, multicentre, nationwide study in China on patients with early SpA including ankylosing spondylitis (AS, also known as radiographic axial spondyloarthritis) and non-radiographic axial SpA. The objectives of CESPIC are to learn about the course of SpA during the very early stage of the disease, to appropriately assess the outcome including radiographic progression of patients after several years of follow-up, to identify outcome predictors, to assess quality of life, function, and costs (direct and indirect costs). CESPIC has been recently expanded to recruit patients with other forms of SpA / conditions associated with SpA: reactive arthritis, acute anterior uveitis, Crohn's disease as well as with psoriasis / axial psoriatic arthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Crohn's disease. Acute anterior uveitis. Psoriatic arthritis with axial involvement. Reactive arthritis.
排除标准
- •Infections, Malignancies, Major cardiovascular events, Lower intestinal perforations Other adverse events
研究组 & 干预措施
Ankylosing spondylitis
Ankylosing spondylitis according to the modified New York criteria or with the clinical diagnosis of AS/r-axSpA fulfilling the ASAS Classification Criteria AND the mNY criteria plus having the indiaction for starting a bDMARD therapy according to the treating rheumatologist
干预措施: Celecoxib (Drug)
Non-radiographic axial spondyloarthritis
Patients with clinical characteristics of axial SpA but not fulfilling the modified New York criteria for which radiographic sacroiliitis is essential or with the clinical diagnosis of nr-axSpA fulfilling the ASAS Classification Criteria not fulfilling the mNY criteria and the indiaction for starting a bDMARD therapy according to the treating rheumatologist
干预措施: Celecoxib (Drug)
Juvenile spondyloarthritis
Patients with juvenile spondyloarthritis (juvenile ankylosing spondylitis, juvenile non-AS-spondyloarthritis).
干预措施: Celecoxib (Drug)
Crohn's disease
Patients with Crohn's disease
干预措施: Celecoxib (Drug)
Acute anterior uveitis
Patients with acute anterior uveitis
干预措施: Celecoxib (Drug)
Axial psoriatic arthritis
Patients with the clinical diagnosis of psoriatic arthritis with axial involvement (sacroiliac joints and/or spine) (axPsA)
干预措施: Celecoxib (Drug)
Reactive arthritis
Patients with reactive arthritis
干预措施: Celecoxib (Drug)
结局指标
主要结局
CRP
时间窗: baseline
A c-reactive protein test measures the level of c-reactive protein (CRP) in a sample of your blood. CRP is a protein that your liver makes. Normally, you have low levels of c-reactive protein in your blood. Your liver releases more CRP into your bloodstream if you have inflammation in your body. High levels of CRP may mean you have a serious health condition that causes inflammation.
BASMI
时间窗: baseline
BASMI was created to help clinicians accurately assess axial status (through five measurements) of individuals suffering from Ankylosing Spondylitis. The measurements are then interpreted to derive a metrology index to define clinically significant changes in spinal mobility.
ASDAS
时间窗: baseline
The Ankylosing Spondylitis Disease Activity Score (ASDAS) is a new composite index to assess disease activity in Ankylosing Spondylitis (AS)1. It combines five disease activity variables with only partial overlap, resulting in one single score with better truth (validity), enhanced discriminative capacity and improved sensitivity to change as compared to single-item variables
BASFI
时间窗: baseline
The Bath Ankylosing Spondylitis Functional Index is to determine the degree of functional limitation in patients with the inflammatory autoimmune disease Ankylosing Spondylitis (AS).
BASDAI
时间窗: baseline
The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) disease activity questionnaire contains six questions regarding subjective symptoms
次要结局
- ASAS40(baseline)
- ASAS20(baseline)
研究者
Guangxing Chen
Professor, Director
Southwest Hospital, China