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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
  Purpose

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 Intervention
Rheumatoid Arthritis
Device: ultra-sonography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Sensitivity of Echography in Arthritis

Resource links provided by NLM:


Further study details as provided by Association de Recherche Clinique en Rhumatologie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: March 2007
Estimated Study Completion Date: April 2010
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
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.
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: March 7, 2007
Last Updated: August 25, 2009
Health Authority: France: Ministry of Health

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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 20, 2014