Cross-validation of a Predictive Model of Response to Anti-TNF Alpha Based on Oxylipin Response in Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 3
- 主要终点
- Whole Blood Oxylipin Response (WBOR)
研究概览
简要总结
The goal of this clinical trial is to use a blood test to predict whether a participant diagnosed with rheumatoid arthritis will respond to anti-TNF alpha treatment . The main questions it aims to answer is:
Is the predictive model created using oxylipins effective?
Participants starting anti-TNF alpha treatment will have a blood sample taken before starting treatment and 6 months afterwards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Male or female patient aged 18 years or older with rheumatoid arthritis according to ACR EULAR 2010 criteria
- •Active disease as defined by DAS-28-CRP>3.2
- •Naive to targeted biologic or synthetic therapy
- •Rheumatologist's decision to start anti-TNFα treatment
- •Stable corticosteroid therapy ≤ 10 mg/day
- •Patient enrolled in or benefiting from a social security scheme
- •Patient who has given written informed consent to participate in the study
排除标准
- •Contraindication to biological treatment (cancer or history of cancer)
- •Treatment with non-steroidal anti-inflammatory drugs in the 2 weeks prior to enrolment
- •Protected persons (pregnant and/or breastfeeding women, persons under guardianship or conservatorship)
研究组 & 干预措施
Cohort
Intervention : blood sample added to the standard blood test at visit Inclusion and Month 6.
干预措施: Blood sample Truculture (Other)
结局指标
主要结局
Whole Blood Oxylipin Response (WBOR)
时间窗: Month 0
i.e. the ability of the host's blood cells to produce oxylipins in response to an immune stimulus. A wide range of several dozen pro- and anti-inflammatory oxylipins secreted by stimulated blood cells.
EULAR clinical response
时间窗: Month 6
EULAR clinical response (based on change in DAS28 score) assessed after 6 months of anti-TNFα treatment. EULAR non-responders are defined as RA patients who did not achieve a good or moderate EULAR response after 6 months of treatment, discontinued the drug, started a new bDMARD or increased the oral corticosteroid dose to more than 10 mg/d at the second visit.
次要结局
- Performance of the predictive response model(Month 0)
- Cytokine response(Month 6)
- Whole Blood Oxylipin Response (WBOR)(Month 6)
- Polyunsaturated fat (PUFA) content of blood cells(Month 6)
- Polyunsaturated fat (PUFA) content of blood cells(Month 0)
- Cytokine response(Month 0)