Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 5
- 主要终点
- Value of joint inflammation
研究概览
简要总结
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs).
Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.
详细描述
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying anti-rheumatic drugs. In patients responding insufficiently to Methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARD) strategies, with or without glucocorticoids, biological DMARD (TNF inhibitors, abatacept or tocilizumab, and, under certain circumstances, rituximab) should be commenced with Methotrexate. Among DMARD available in 2015, abatacept has demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction. Monitoring rheumatoid arthritis patients after starting abatacept by US exams observed a strong reduction of power Doppler ultra-sonography at 3 months in two third of patients.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept initiation.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form,
- •Age ≥ 18 years,
- •Rheumatoid arthritis diagnosis according to ACR/EULAR 2010 criteria
- •Abatacept therapy sub-cutaneous required according EULAR recommendations
- •Patients affiliated to health insurance
排除标准
- •Other arthritis than rheumatoid arthritis,
- •Contraindication to abatacept,
- •Concomitant treatment with zoledronic acid (Aclasta®) or denosumab (Prolia®),
- •Injection intravenously or intra-articular at the 2nd and 3rd metacarpophalangeal joint of the dominant hand during the 3 months prior to inclusion,
- •Prior or planned joint surgery at the 2nd or 3rd metacarpophalangeal joint of the dominant hand over the one year study,
- •No recent used of high density contrast material,
- •Pregnancy or breastfeeding.
结局指标
主要结局
Value of joint inflammation
时间窗: 1 year
The predictive value of persistent joint inflammation on volumetric trabecular bone density is measured by high resolution pQCT (peripheral Quantitative Computed Tomography) after 1 year treatment with Abatacept.
次要结局
未报告次要终点