Evaluation by HR-pQCT of Bone Microarchitecture Changes in Patients With Rheumatoid Arthritis Under Anti-TNF Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- trabecular volume (bone volume / tissue volume) in percent for bone microarchitecture measured by HR-pQCT
研究概览
简要总结
Rheumatoid arthritis (RA) is the most common chronic inflammatory joint disease in adults and is characterized by chronic inflammation of the joints leading to their destruction, resulting in a major loss of function.
The investigators propose a pilot study for studying changes in bone microarchitecture with High Resolution peripheral micro Computerized Tomography (HR-pQCT) in patients with RA treated with anti-TNF(Tumor Necrosis Factor), with the measurement of micro-architectural parameters in subchondral area near an inflammatory joint during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men from 18 to 65 years old
- •Women from 18 years old to menopause
- •Patient with a polyarthritis rheumatoid no controlled by the usual treatment (DAS28>3)
- •Patient affiliated or beneficiary of a national insurance system
- •Patient with signed consent
排除标准
- •Concomitant osseous disease (Paget's disease, osteomalacia...)
- •Endocrinopathy defined on biological criteria (Cushing's disease, hyperthyroidism, hypogonadism...)
- •Patients under protection of justice
- •Refusal consent
研究组 & 干预措施
patients with anti-TNF therapy
patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy
干预措施: HR-pQCT (Device)
结局指标
主要结局
trabecular volume (bone volume / tissue volume) in percent for bone microarchitecture measured by HR-pQCT
时间窗: 12 months after intitiation of anti-TNF treatment
Describe changes to trabecular volume of the distal radius in subchondral area in patients with rheumatoid polyarthritis inadequately controlled by a conventional treatment, occurring during the first 12 months of initiation of an anti-TNF therapy (Infliximab®, Etanercept®, Adalimumab®).
次要结局
未报告次要终点