Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Rheumatoid Arthritis
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Basic Science

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Ultrasound (US) is an imaging technique increasingly used in rheumatologic practice. US is a noninvasive, bedside, objective and sensitive tool for visualizing synovial inflammatory joint changes in RA that were not detected by conventional clinical examination. US has added value over clinical mana...

Ultrasound (US) is an imaging technique increasingly used in rheumatologic practice. US is a noninvasive, bedside, objective and sensitive tool for visualizing synovial inflammatory joint changes in RA that were not detected by conventional clinical examination. US has added value over clinical management of RA patients and is potentially helpful at several steps of the disease: early diagnosis of early arthritis, evaluation of disease activity, identification of poor prognostic RA, and possibly confirmation of remission status before tapering treatment. The potential role of this technique in the management of RA has been highlighted by the recent EULAR recommendations on how to use imaging in RA clinical practice. Nevertheless, only few studies have evaluated the value of US to predict clinical outcome and therapeutic response. In a Spanish longitudinal study including 42 early RA patients, the number and grade of Power-Doppler ultrasound (PDUS) synovitis were the best parameters correlated with disease activity at following visit. Since 2004, the OMERACT (Outcome Measures in Rheumatology) group has evaluated metric properties of US in RA. A semi-quantitative (0-3) score of synovitis combining B-mode and Power Doppler abnormalities was defined, the PDUS Global OMERACTEULAR Synovitis Score (GLOESS). This score recently demonstrated its responsiveness in a multicentre therapeutic trial of patients starting a treatment by abatacept, as soon as after one week of treatment. However, in this study, variation of this score until 4 months failed to demonstrate a correlation with clinical status or response as measured by DAS28-derived criteria at 6 months, suggesting that these tools evaluate different aspects of disease activity in RA and should be considered complementary in clinical practice, or maybe that DAS28 is not a sufficient stringent composite score. A similar semi-quantitative (0-3) score of tenosynovitis was developed and validated by the OMERACT. On the other hand, no study to date has demonstrated the responsiveness of this tenosynovitis score in RA. However, one study compared intra-muscular glucocorticoid or glucocorticoid administered in soft tissues and demonstrated that peri-tendinous infusions were more efficient at 3 months, both clinically and with US. Patient-reported outcomes (PROs) are questionnaires used in clinical trials and daily care, with answers directly collected from patients. They allow the evaluation of domains that are often neglected (fatigue, quality of life, subjective disease activity, sleep disorders, etc). PROs are used as multifunctional criteria and therefore can be used as prognostic, therapeutic-evaluation or therapeutic-decision outcomes. Many studies have compared patient self-assessment and evaluation of disease activity by an experienced clinician to determine whether substituting patient assessment of disease activity is possible. Clinical response during the first 3 months is associated with remission or low disease activity in the long term (6 to 12 months) in some studies. However, the real added value of US (or PRO) to predict medium or long term clinical outcome is not so well-known.

Tracking Information

NCT #
NCT04084223
Collaborators
  • Centre Hospitalier Universitaire de N?mes
  • University Hospital, Clermont-Ferrand
  • University Hospital, Bordeaux
  • University Hospital, Toulouse
Investigators
Principal Investigator: Gaël MOUTERDE, MD University Hospital, Montpellier