Agreement Between Disease Activity and Ultrasound Scoring (Naredo-12) in Patients With Rheumatoid Arthritis With Clinical Remission in Daily Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 225
- 主要终点
- correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI)
研究概览
简要总结
Evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.
详细描述
Clinical remission is now a realistic goal in managing rheumatoid arthritis (RA) with treat to target strategy assessed according to different composite scores (DAS28, Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), ACR-EULAR 2011 for remission). There are, however, no validated ultrasound remission criteria because of continuing uncertainty on the signification of persistent synovial hypertrophy in B-mode or Power Doppler (PD) mode in RA patients in clinical remission.
The objective was to evaluate correlations between the validated 12 joints-Naredo ultrasound score (B-mode (0-3), PD (0-3) or PDUS (0-3, max between B-mode or PD)) and the DAS28-ESR, DAS28-CRP, CDAI, SDAI and ACR-EULAR criteria for remission in routine care.
This french multicenter cross-sectional study took place in 11 rheumatology departments. The inter and intra-observer reproducibility for the ultrasound scoring was good to excellent. Inclusion criteria were as follows: RA meeting ACR-EULAR criteria, <15 years of progression, DAS-28-ESR<2.6 for at least 3 months, with a stable treatment including corticoids if necessary (equivalent prednisone<0.1 mg/kg) for 6 months. A standardized US examination was performed by an experience ultrasonographist blinded to clinical data. Spearman's correlation coefficients were determined between the Naredo12 B-mode (min-max,0-36), PD mode (0-36) and PDUS (0-36) scores and the different clinical remission scores. The impact of disease duration or duration of the clinical remission on ultrasound scores was also assessed (Kruskall-Wallis's test).
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
- •Adults (âged of 18 or more),
- •Rheumatoid arthritis according to ACR-EULAR 2010 criteria, during less than 10 years at least
- •Remission according to DAS28-VS (<2.6) since 3 months at least,
- •Disease modifying anti-rheumatic drugs and/or biotherapy stable dose since 6 months at least
- •Steroids ≤0.1 mg/kg/day without high dose during the last 3 months
- •Oral and written information and consent
排除标准
- •Patient participating to a clinical trial about rheumatoid arthritis treatment
- •Patient under administrative supervision
结局指标
主要结局
correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI)
时间窗: august 2015-april 2016
Composit outcome measure : Ultrasonography score PD mode (0-36) Disease activityscore DAS28-ESR (0-10) Disease activity score DAS28-CRP (0-10) Disease activity score SDAI (0-86) Disease activity score CDAI (0-76)
次要结局
- Correlation between ultrasonographic score PD mode and disease activity scores (DAS28, SDAI, CDAI).(august 2015-april 2016)
- Correlation between ultrasonography scores PDUS and disease activity scores (DAS28, SDAI, CDAI).(august 2015-april 2016)
