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临床试验/NCT05039216
NCT05039216招募中不适用

Biobank for Inflammatory Chronic Diseases and Osteoporosis of TOULouse

University Hospital, Toulouse1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2021年9月13日最近更新:
适应症
干预措施
相关药物

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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