Clinical trial NCT00444691: Sensitivity of Echography in Arthritis
Official title: Sensitivity of Echography in Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Keywords: synovitis score
sensitivity to change
clinical examination
ultra-sonography
Lead sponsor: Association de Recherche Clinique en Rhumatologie
Sponsor class: OTHER
Collaborators: name: RCTs
First posted: 2007-03-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* Minor patients.
* Pregnancy.
* Breastfeeding.

Primary outcomes:
measure: joint score evaluated by clinical examination
timeFrame: baseline and 1, 2, 3 and 4 months after baseline
measure: joint score evaluated by ultra-sonography
timeFrame: baseline and 1, 2, 3 and 4 months after baseline
Secondary outcomes:
measure: DAS28 Synovial index
timeFrame: baseline and 1, 2, 3 and 4 months after baseline
measure: ACR Synovial index (66 sites)
timeFrame: baseline and 1, 2, 3 and 4 months after baseline
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU-Brugmann
city: Boulogne
country: France
facility: Hôpital Ambroise Paré
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Caen
country: France
facility: CHU Côte de Nacre
city: Grenoble
country: France
facility: CHU A. Michallon
city: Le Kremlin Bicetre
country: France
facility: Hôpital Bicêtre
city: Paris
country: France
facility: Hôpital Cochin
city: Paris
country: France
facility: Hôpital de la Pitié
city: Rennes
country: France
facility: CHU de RENNES - Hôpital Sud
city: Vandoeuvre Les Nancy
country: France
facility: CHU Nancy-Brabois
Study officials:
affiliation: ARCR
name: Maxime DOUGADOS, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chales G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.