The Oxylipin Response as a New PrEdictive Biomarker of Patient Responsiveness to Biotherapy in Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Quantification of total oxylipins
研究概览
简要总结
OPERA aims to better understand and predict the responsiveness of rheumatoid arthrits (RA) patients to biological disease modifying anti-rheumatic drugs (bDMARDs).
Our objectives will be (i) to determine, at baseline, the differences of oxylipin response between responders vs non-responders to Anti-Tumor necrosis factor (Anti TNF) and (ii) to investigate the relationships between the oxylipin response, the polyunsatured fatty acid (PUFA) content of immune cells and the cytokine response.
详细描述
30 RA patients starting an anti-TNF will be recruited.
Before and after 6-months of anti-TNF treatment, blood will be collected using the TruCulture system (2x 1ml in non-stimulated and Lipopolysaccharide (LPS)-stimulated TruCulture tubes) to measure Whole Blood Oxylipin Response (WBOR), cytokine response, PUFA cell content and gene expression under homeostatic and stimulated conditions (i.e. LPS).
At baseline and after 6 months of treatment, the rheumatologist will perform a clinical evaluation of their RA patients using Disease Activity Score using 28 joint-count (DAS28-CRP). Non-responders will be defined as RA patients failing to achieve good or moderate EULAR response after 6 month of anti-TNF treatment, discontinued the drug, initiated a new bDMARD, or increased dosage of oral corticosteroids greater than 10 mg/d at the second visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Rheumatoid patient according to ACR-EULAR (American college of rheumatology-European League Against Rheumatism) 2010 criteria,
- •Active disease defined by a DAS28-CRP>3.2,
- •Biological and targeted synthetic DMARDs naïve,
- •Indication for treatment with anti-TNF
- •Stable corticosteroid therapy ≤ 10 mg/day
排除标准
- •Contra-indications to a biological DMARDS (current or recent cancer, active infection),
- •Non-steroidal anti-inflammatory drugs (NSAIDs) treatment during the last 2 weeks before inclusion
结局指标
主要结局
Quantification of total oxylipins
时间窗: Baseline
Quantitative profiling procedure for oxylipins
次要结局
- Quantification of cytokines(6 month)
- EULAR Response(6 month)
- Quantification of total oxylipins(6 month)
- Quantification of polyunsatured fatty acids in blood cells(6 month)