Changes in Ultrasonographic Assessment of Inflammation Upon Initiation of Adalimumab Combination Therapy in Chinese Rheumatoid Arthritis Patients With Inadequate Response to Methotrexate
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 4
- 主要终点
- Change in power Doppler (PD) semi-quantitative scores from baseline
研究概览
简要总结
Prospective, post-marketing, multi-center, open-label study to explore if the initiation of adalimumab could influence grey-scale (GS) and power Doppler (PD) ultrasonographic (US) score using 36-joint plus 4-tendon scoring system, and validate the applicability of different simplified US joint scoring systems.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Moderate to severe RA despite treatment with methotrexate (MTX).
- •Eligible to use adalimumab according to the local label without any contraindication.
- •Naïve to adalimumab, and participants with prior exposure to any other biologic disease-modifying antirheumatic drugs (DMARDs) should have experienced at least five half-lives of the biologics after treatment discontinuation.
- •Participants for whom investigators decided to prescribe adalimumab as per local label and are initiating adalimumab at baseline.
排除标准
- •Other inflammatory condition which may affect the signs on joints ultrasound (eg, gouty arthritis, or other chronic rheumatic disease besides RA).
- •Currently being treated with or has been treated with any investigational drug of chemical or biologic nature within a minimum of 30 days of the baseline visit.
- •Participants with contraindication or are not appropriate to use adalimumab according to local label or investigators' judgment.
结局指标
主要结局
Change in power Doppler (PD) semi-quantitative scores from baseline
时间窗: Week 0 (baseline) and Week 12
Change in PD semi-quantitative scores from baseline at week 12, using 36-joint scoring system
Correlation between the 36-joint plus 4-tendon assessment versus simplified joint power Doppler (PD) ultrasonographic (US) assessments, which include 12-joint/7-joint/6-joint plus 4-tendon systems.
时间窗: Week 0 (baseline) and Week 12
Correlation coefficients will be presented to assess the correlation between the 36-joint plus 4-tendon PDUS assessment versus the simplified 12-joint/7-joint/6-joint plus 4-tendon assessments.
Change from baseline in grey-scale (GS) scores
时间窗: Week 0 (baseline) and Week 12
Change in GS scores from baseline at Week 12, using 36-joint scoring system
次要结局
- Percentage of participants achieving low disease activity(Baseline (Week 0) to Week 12 and Week 20)
- Change from baseline in counts of joints with US detected bone erosion(Baseline (Week 0) to Week 12)
- Percentage of patients achieving clinical remission(Baseline (Week 0) to Week 12 and Week 20)
- Correlation between changes of 36-joint plus 4-tendon PDUS score and disease activity DAS 28-CRP.(Baseline (Week 0) to Week 20)
- Change in DAS 28-CRP from baseline(Baseline (Week 0) to Week 12 and Week 20)