Rheumatoid Arthritis in Remission
Conditions
Keywords
Rheumatoid arthritis, Articular ultrasound, Synovitis, Relapse risk
Brief summary
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA). At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years. However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care. The investigator propose to conduct a prospective, bi-center, non randomized study.
Detailed description
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month. The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons
Interventions
OTHERArticular ultrasound
(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria * Patient treated by DMARDs (disease-modifying antirheumatic drug) * Patient in confirmed remission for less than 6 months
Exclusion criteria
* Patient participating simultaneously in another clinical study with blind treatment * Patient participating simultaneously in another clinical study involving decreasing of drug dose * Patient in post clinical study exclusion period * patients subject to legal protection measures * Patient unable to read French * Pregnant or breast-feeding women * patient treated with Rituximab
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1 year pejorative evolution | 1 year after inclusion | Number of patient with a clinical relapse |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| RA (Rheumatoid Arthritis) remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | Evaluation of the remission duration (patient in both clinical and ultrasound remission) |
| RA ultrasound remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | Evaluation of the ultrasound remission duration |
| RA clinical remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | Evaluation of the clinical remission duration |
| Structural progression | 1 year after inclusion | Number of patient with a structural progression of the illness |
| Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments) | At baseline | identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission |
| Radiographic progression at 1 year | 1 year after inclusion | Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis |
| Intra-observator reproductibility | 1 year after inclusion | Evaluating the intra-observer reliability for US synovitis through study completion |
| Clinical relapse at one year | 1 year after inclusion | Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data |
Countries
France
Outcome results
None listed