Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- EULAR response after 3 months
研究概览
简要总结
The aim of this study is to constitute a biobank for patients followed in the Rheumatology center of Toulouse University Hospital for a chronic inflammatory rheumatism including rheumatoid arthritis (RA), spondyloarthritis(SpA), and psoriatic arthritis (PsA) or a chronic bone disease including osteoporosis in order to identify biomarkers associated with therapeutic response.
详细描述
Biologic ant targeted synthetic disease modifying anti-rheumatic drugs (bDMARDs and tsDMARDs) have greatly improved the prognosis of chronic inflammatory diseases. To date, many bDMARDs and tsDMARDs targeting different immunologic mechanisms are available to treat RA, SpA or PsA. However, the choice of the treatment and its mechanism of action is based on physician decision and experience. Indeed, predictive clinical and biological factors associated with therapeutic response that could help the physician to make his/her choice are lacking. The aim of BIOTOUL is to collect and store biologic samples in patients with RA, SpA or PsA who begin a new bDMARD or tsDMARD. This biobank will permit to study several biomarkers and assess the association between such markers and response to therapy.
Furthermore, osteoporosis is a chronic disease leading to fractures and disability. Several ant-osteoporotic drugs are now available and biomarker(s) that would help the physician to choose the best therapeutic sequence are lacking. BIOTOUL will also include patients with osteoporosis to identify biomarkers associated with severity and response to anti-osteoporotic treatments.
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 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic inflammatory rheumatism including RA, SpA or PsA or patients with primary or secondary osteoporosis
- •With National Health Assurance
- •Able to consent to the study
排除标准
- •Pregnancy or breastfeeding
- •Not able to give a consent
- •Severe anemia (Hb<10g/L)
研究组 & 干预措施
patients initiating a biotherapy or a target treatment
Blood sampling
干预措施: Blood sampling (Biological)
patients with chronic inflammatory rheumatism, weakening osteopathy or mechanical pathology
Blood sampling
干预措施: Blood sampling (Biological)
结局指标
主要结局
EULAR response after 3 months
时间窗: after 3 months
EULAR response after 3 months
次要结局
未报告次要终点
