18F-FDG Positron Emission Tomography to Study the Response to Adalimumab in Rheumatoid Arthritis. A Monocentric Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- There is no primary outcome measure specified for this study.
研究概览
简要总结
Biologics are routinely used for the treatment of rheumatoid arthritis (RA). Adalimumab is a human monoclonal antibody that inhibit the Tumor Necrosis Factor alpha (TNF-alpha). Identification of RA patients who respond to biologics is a challenging goal to avoid unnecessarily, costly and potentially harmful treatment.
The aim of the study is to address if 18 F FDG is a valuable biomarker for the assessment of the clinical response in RA with TNF-alpha blocking agent. Eight patients fulfilling the ACR (American College of Rheumatology) criteria will by enrolled. Patient will receive adalimumab according to the current guidelines i.e. 40mg /14 days sub cutaneously. The decision will stand on a high activity of the disease defined by the DAS 28 (Disease Activity Score) above 5.1. Positron emission tomography will be performed before, 2 and 12 weeks after the begin of the treatment. The response to adalimumab will by assessed by the SUV (standard Unit value) measured on the inflammatory joints of hands, wrist, ankle, feet and knees and compared to measurement of clinical (total swollen and tender joints count) echographic (synovium thickness and power doppler) and chemical biomarkers (erythrocyte sedimentation rate, C reactive protein).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active Rheumatoid arthritis PR définie selon les critères ACR (1987) (annexe 7) [18], Activité importante de la maladie (DAS 28 > 5,1) (annexe 5) [7], Indication d'un traitement par adalimumab (en accord avec l'A.M.M.), Homme ou femme dont l'âge est supérieur ou égal à 18 ans, Acceptant de participer à l'étude et ayant donné son consentement éclairé, Affiliés ou bénéficiaire d'un régime de sécurité sociale.
排除标准
- 未提供
研究组 & 干预措施
No arm
干预措施: adalimumab (Drug)
结局指标
主要结局
There is no primary outcome measure specified for this study.
次要结局
- There are no secondary outcome measures specified for this study.
