Role of Ultrasound for Evaluating Rheumatoid Arthritis in Remission

Study Overview
=================
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

Official Title
-----------------
Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study

Conditions
-----------------
Rheumatoid Arthritis in Remission

Intervention / Treatment
-----------------
* Other: Articular ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Study patient<br>Articular ultrasound at each study follow-up | Other: Articular ultrasound<br>* (Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year pejorative evolution | Number of patient with a clinical relapse | 1 year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Structural progression | Number of patient with a structural progression of the illness | 1 year after inclusion | 
| RA (Rheumatoid Arthritis) remission duration | Evaluation of the remission duration (patient in both clinical and ultrasound remission) | At each follow-up (3,6,9 and 12 months after inclusion) | 
| RA ultrasound remission duration | Evaluation of the ultrasound remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | 
| RA clinical remission duration | Evaluation of the clinical remission duration | At each follow-up (3,6,9 and 12 months after inclusion) | 
| Clinical relapse at one year | Evaluation of the probability of a clinical relapse at 1 year based on the ultrasound data | 1 year after inclusion | 
| Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments) | identifying initial factors that can explain persistence of ultrasound synovitis despite clinical remission | At baseline | 
| Radiographic progression at 1 year | Evaluation at joint level the probability of a radiographic progression in presence of a non active synovitis | 1 year after inclusion | 
| Intra-observator reproductibility | Evaluating the intra-observer reliability for US synovitis through study completion | 1 year after inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rheumatoid arthritis, Articular ultrasound, Synovitis, Relapse risk