Power Doppler in Hand Joints is a Predictor of Therapeutic Failure in Women With Early Rheumatoid Arthritis Naive for Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 主要终点
- Changes in Synovial blood flow (power doppler)
研究概览
简要总结
It is a prospective case-control study with women diagnosed early rheumatoid arthritis. Three therapeutic failures were considered: failure 1 - to the first Disease-modifying antirheumatic drugs (DMARDs) (methotrexate); failure 2 - to the second DMARDs (leflunomide) and failure 3 - to the first immunobiological drugs (adalimumab). Ultrasound was performed bilaterally on the 2nd and 3rd metacarpophalangeal joints (MCFs), proximal interphalangeal joints (IFPs), and wrists (US10). Ultrasound measurements (qualitative and semi-quantitative) evaluated: 1 - inflammatory: synovial and tenosynovial proliferation in gray scale and power Doppler (0-3); 2 - joint damage: bone erosion (qualitative and semi-quantitative) and cartilage damage (qualitative and semi-quantitative). Clinical and laboratory variables were also assessed blindly at baseline and after 12, 24 e 48 weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •early rheumatoid arthritis fulfilment of the 2010 ACR/EULAR RA classification criteria;
- •age between 18-65 years;
- •female gender,
- •naive for treatment.
排除标准
- •use of oral > 10 mg/d glucocorticoid in the previous three weeks;
- •serum aspartate aminotransferase or alanine aminotransferase level > 3 times the upper limit of normal;
- •bone marrow, auto-imune, lymphoproliferative or infectious diseases;
- •pregnancy.
研究组 & 干预措施
Woman with Early Rheumatoid Arthritis
干预措施: Drug protocol (Drug)
结局指标
主要结局
Changes in Synovial blood flow (power doppler)
时间窗: Baseline, after 4, 12, 24 and 48 weeks
Measured in ultrasound examination
次要结局
- Changes in Tenosynovitis(Baseline, after 4, 12, 24 and 48 weeks)
- Changes in C-reactive protein level (mg/liter)(Baseline, after 4, 12, 24 and 48 weeks)
- Change in Synovial Proliferation(Baseline, after 4, 12, 24 and 48 weeks)
- Changes in erythrocyte sedimentation rate level (mm/hour)(Baseline, after 4, 12, 24 and 48 weeks)
- Changes in disease activity score(Baseline, after 4, 12, 24 and 48 weeks)
- Changes in Joint Damage(Baseline, after 4, 12, 24 and 48 weeks)
- Changes in function(Baseline, after 4, 12, 24 and 48 weeks)
- Changes in upper limb function(Baseline, after 4, 12, 24 and 48 weeks)
研究者
Karine Rodrigues da Luz
Principal Investigator
Federal University of São Paulo