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Sensitivity of Echography in Arthritis

Sensitivity of Echography in Arthritis

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00444691
Acronym
SEA
Enrollment
120
Registered
2007-03-08
Start date
2007-03-31
Completion date
2010-04-30
Last updated
2009-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

synovitis score, sensitivity to change, clinical examination, ultra-sonography

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.

Interventions

DEVICEultra-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.

Sponsors

RCTs
CollaboratorINDUSTRY
Association de Recherche Clinique en Rhumatologie
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
joint score evaluated by clinical examinationbaseline and 1, 2, 3 and 4 months after baseline
joint score evaluated by ultra-sonographybaseline and 1, 2, 3 and 4 months after baseline

Secondary

MeasureTime frame
DAS28 Synovial indexbaseline and 1, 2, 3 and 4 months after baseline
ACR Synovial index (66 sites)baseline and 1, 2, 3 and 4 months after baseline

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026