Ultrasound Evaluation of Remission in Rheumatoid Arthritis (EVER-1)

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: Rheumatoid Arthritis Patient With Remission :Ultrasonographic Disease Activity

Study type: Observational

Funder types: Other

Identifiers

NCT02930187

38RC14.258

DR-2015-072 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 225 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Patient participating to a clinical trial about rheumatoid arthritis treatment
• Patient under administrative supervision