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Sensitivity of Echography in Arthritis (SEA)

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ClinicalTrials.gov Identifier: NCT00444691
Recruitment Status : Unknown
Verified August 2009 by Association de Recherche Clinique en Rhumatologie.
Recruitment status was:  Active, not recruiting
First Posted : March 8, 2007
Last Update Posted : August 26, 2009
Sponsor:
Collaborator:
RCTs
Information provided by:
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).


Condition or disease Intervention/treatment
Rheumatoid Arthritis Device: ultra-sonography

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Sensitivity of Echography in Arthritis
Study Start Date : March 2007
Primary Completion Date : August 2008
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    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.


Primary Outcome Measures :
  1. joint score evaluated by clinical examination [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ]
  2. joint score evaluated by ultra-sonography [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ]

Secondary Outcome Measures :
  1. DAS28 Synovial index [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ]
  2. ACR Synovial index (66 sites) [ Time Frame: baseline and 1, 2, 3 and 4 months after baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00444691


Locations
Belgium
CHU-Brugmann
Bruxelles, Belgium, 1020
France
Hôpital Ambroise Paré
Boulogne, France, 92104
CHU de la Cavale Blanche
Brest, France, 29609
CHU Côte de Nacre
Caen, France, 14000
CHU A. Michallon
Grenoble, France, 38000
Hôpital Bicêtre
Le Kremlin Bicetre, France, 94275
Hôpital Cochin
Paris, France, 75006
Hôpital de la Pitié
Paris, France, 75013
CHU de RENNES - Hôpital Sud
Rennes, France, 35000
CHU Nancy-Brabois
Vandoeuvre Les Nancy, France, 54511
Sponsors and Collaborators
Association de Recherche Clinique en Rhumatologie
RCTs
Investigators
Principal Investigator: Maxime DOUGADOS, Professor ARCR

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Maxime DOUGADOS, Association de Recherche Clinique en Rhumatologie
ClinicalTrials.gov Identifier: NCT00444691     History of Changes
Other Study ID Numbers: ARCR 2007/01
2006-A00658-43
First Posted: March 8, 2007    Key Record Dates
Last Update Posted: August 26, 2009
Last Verified: August 2009

Keywords provided by Association de Recherche Clinique en Rhumatologie:
synovitis score
sensitivity to change
clinical examination
ultra-sonography

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Hypersensitivity
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases