Sensitivity of Echography in Arthritis

Rheumatoid Arthritis Clinical Trial

— SEA  

Official title:

Sensitivity of Echography in Arthritis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00444691
• Other study ID #: ARCR 2007/01
• Secondary ID: 2006-A00658-43
• Status: Active, not recruiting
• Phase: N/A
• First received: March 7, 2007
• Last updated: August 25, 2009
• Start date: March 2007
• Est. completion date: April 2010

Study information

• Verified date: August 2009
• Source: Association de Recherche Clinique en Rhumatologie
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 120
• Est. completion date: April 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Device:
• ultra-sonography
o The ultrasonographic evaluation was performed on 38 joints: the 28 joints included in DAS28 (e.g. shoulderx2, elbowx2, wristx2, metacarpo-phalangeal (MCP)x10, proximal inter phalangeal (PIP)x10, kneex2) and also the metatarso-phalangeal (MTPx10). Systematic multiplanar gray-scale (mode B) and Power Doppler examination was carried out with commercially available real-time scanners using multi-frequency linear transducers (7-12 MHz). The ultrasonographic evaluation was performed at baseline and 1, 2, 3, and 4 months after baseline.

Locations

Country	Name	City	State
Belgium	CHU-Brugmann	Bruxelles
France	Hôpital Ambroise Paré	Boulogne
France	CHU de la Cavale Blanche	Brest
France	CHU Côte de Nacre	Caen
France	CHU A. Michallon	Grenoble
France	Hôpital Bicêtre	Le Kremlin Bicetre
France	Hôpital Cochin	Paris
France	Hôpital de la Pitié	Paris
France	CHU de RENNES - Hôpital Sud	Rennes
France	CHU Nancy-Brabois	Vandoeuvre Les Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Association de Recherche Clinique en Rhumatologie	RCTs

Countries where clinical trial is conducted

Belgium,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	joint score evaluated by clinical examination		baseline and 1, 2, 3 and 4 months after baseline	No
Primary	joint score evaluated by ultra-sonography		baseline and 1, 2, 3 and 4 months after baseline	No
Secondary	DAS28 Synovial index		baseline and 1, 2, 3 and 4 months after baseline	No
Secondary	ACR Synovial index (66 sites)		baseline and 1, 2, 3 and 4 months after baseline	No