Ultrasound Evaluation of Remission in Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity
- Registration Number
- NCT02930187
- Lead Sponsor
- University Hospital, Grenoble
- Brief Summary
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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 225
- 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
- Patient participating to a clinical trial about rheumatoid arthritis treatment
- Patient under administrative supervision
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method correlation between ultrasonography score Naredo12 B-mode and disease activity score (DAS28, SDAI, CDAI) 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)
- Secondary Outcome Measures
Name Time Method Correlation between ultrasonographic score PD mode and disease activity scores (DAS28, SDAI, CDAI). 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)
Correlation between ultrasonography scores PDUS and disease activity scores (DAS28, SDAI, CDAI). 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)