Sensitivity of Echography in Arthritis (SEA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Association de Recherche Clinique en Rhumatologie.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
RCTs
Information provided by:
Association de Recherche Clinique en Rhumatologie
ClinicalTrials.gov Identifier:
NCT00444691
First received: March 7, 2007
Last updated: August 25, 2009
Last verified: August 2009

March 7, 2007
August 25, 2009
March 2007
August 2008   (final data collection date for primary outcome measure)
  • joint score evaluated by clinical examination [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ] [ Designated as safety issue: No ]
  • joint score evaluated by ultra-sonography [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ] [ Designated as safety issue: No ]
  • joint score evaluated by clinical examination
  • joint score evaluated by ultra-sonography
Complete list of historical versions of study NCT00444691 on ClinicalTrials.gov Archive Site
  • DAS28 Synovial index [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ] [ Designated as safety issue: No ]
  • ACR Synovial index (66 sites) [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ] [ Designated as safety issue: No ]
  • DAS28 Synovial index
  • ACR Synovial index (66 sites)
Not Provided
Not Provided
 
Sensitivity of Echography in Arthritis
Sensitivity of Echography in Arthritis

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).

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Rheumatoid Arthritis
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.

Other Names:
  • scanners:
  • ESAOTE Technos MPX
  • TOSHIBA APLIO
  • ESAOTE MyLab
  • PHILIPS HD11
  • BK Mini Focus.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
120
April 2010
August 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   France
 
NCT00444691
ARCR 2007/01, 2006-A00658-43
No
Professor Maxime DOUGADOS, Association de Recherche Clinique en Rhumatologie
Association de Recherche Clinique en Rhumatologie
RCTs
Principal Investigator: Maxime DOUGADOS, Professor ARCR
Association de Recherche Clinique en Rhumatologie
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP