Sensitivity of Echography in Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT00444691
- Lead Sponsor
- Association de Recherche Clinique en Rhumatologie
- Brief Summary
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).
An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA).
It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments.
In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients.
Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).
- Detailed Description
This is a multicenter, (10 French centers and 1 Belgian center), prospective (4-month patients' follow-up) interventional study in 120 patients with rheumatoid arthritis justifying anti-TNF treatment.
The overall duration of the study will be 8 months composed of a 4-month inclusion period and a 4-month follow-up period for each patient. Moreover, X-ray evaluations of hands and feet will be performed 2 years from the beginning of the study in order to assess the changes in structural damage.
During the patients' participation, 6 visits are planned: an inclusion visit then, a follow-up visit at 1, 2 and 3 months from the inclusion visit, and a final evaluation visit at 4 months from the inclusion visit. At each visit, synovitis will be evaluated using both methods: clinical examination and ultrasonography. For a same patient, clinical evaluation of synovitis will have to be performed - during the entire study - by the same rheumatologist and the ultrasonographic evaluation will have to be performed by the same ultrasonographist (different from the rheumatologist) and always using the same ultrasonograph.
Finally, patients will be performed anterior X-rays of hands and feet two years from the beginning of the study whatever the ongoing RA treatment.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 120
- Patients with rheumatoid arthritis meeting ACR criteria.
- Justifying anti-TNF alpha treatment (switch or first administration).
- To have at least 6 synovitis at the clinical examination necessary for the DAS evaluation
- To accept to participate in this study (informed consent signed).
- Minor patients.
- Pregnancy.
- Breastfeeding.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method joint score evaluated by clinical examination baseline and 1, 2, 3 and 4 months after baseline joint score evaluated by ultra-sonography baseline and 1, 2, 3 and 4 months after baseline
- Secondary Outcome Measures
Name Time Method DAS28 Synovial index baseline and 1, 2, 3 and 4 months after baseline ACR Synovial index (66 sites) baseline and 1, 2, 3 and 4 months after baseline
Trial Locations
- Locations (10)
CHU-Brugmann
馃嚙馃嚜Bruxelles, Belgium
H么pital Ambroise Par茅
馃嚝馃嚪Boulogne, France
CHU de la Cavale Blanche
馃嚝馃嚪Brest, France
CHU C么te de Nacre
馃嚝馃嚪Caen, France
H么pital Cochin
馃嚝馃嚪Paris, France
H么pital de la Piti茅
馃嚝馃嚪Paris, France
CHU de RENNES - H么pital Sud
馃嚝馃嚪Rennes, France
CHU A. Michallon
馃嚝馃嚪Grenoble, France
H么pital Bic锚tre
馃嚝馃嚪Le Kremlin Bicetre, France
CHU Nancy-Brabois
馃嚝馃嚪Vandoeuvre Les Nancy, France