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临床试验/NCT02930187
NCT02930187已完成不适用

Agreement Between Disease Activity and Ultrasound Scoring (Naredo-12) in Patients With Rheumatoid Arthritis With Clinical Remission in Daily Practice.

University Hospital, Grenoble0 个研究点目标入组 225 人开始时间: 2015年3月最近更新:
适应症

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

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)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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