Sensitivity of Echography in Arthritis (SEA)

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).

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: 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
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1020
    • Chu-Brugmann
• France
  • Boulogne, France, 92104
    • Hôpital Ambroise Paré
  • Brest, France, 29609
    • CHU de la Cavale Blanche
  • Caen, France, 14000
    • CHU côte de Nacre
  • Grenoble, France, 38000
    • CHU A. Michallon
  • Le Kremlin Bicetre, France, 94275
    • Hôpital Bicêtre
  • Paris, France, 75006
    • Hôpital COCHIN
  • Paris, France, 75013
    • Hôpital de la Pitié
  • Rennes, France, 35000
    • CHU de Rennes - Hôpital Sud
  • Vandoeuvre Les Nancy, France, 54511
    • CHU Nancy-Brabois

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
joint score evaluated by clinical examination	baseline and 1, 2, 3 and 4 months after baseline
joint score evaluated by ultra-sonography	baseline and 1, 2, 3 and 4 months after baseline

Secondary Outcome Measures

Outcome Measure	Time Frame
DAS28 Synovial index	baseline and 1, 2, 3 and 4 months after baseline
ACR Synovial index (66 sites)	baseline and 1, 2, 3 and 4 months after baseline

Collaborators and Investigators

• Sponsor: Association de Recherche Clinique en Rhumatologie
• Collaborators: RCTs
• Investigators: Principal Investigator: Maxime DOUGADOS, Professor, ARCR

Publications and helpful links

General Publications

• Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chales G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): August 1, 2008
• Study Completion (Anticipated): April 1, 2010

Study Registration Dates

• First Submitted: March 7, 2007
• First Submitted That Met QC Criteria: March 7, 2007
• First Posted (Estimate): March 8, 2007

Study Record Updates

• Last Update Posted (Estimate): August 26, 2009
• Last Update Submitted That Met QC Criteria: August 25, 2009
• Last Verified: August 1, 2009

More Information

Terms related to this study

• Keywords: synovitis score; sensitivity to change; clinical examination; ultra-sonography
• Additional Relevant MeSH Terms: Immune System Diseases; Joint Diseases; Musculoskeletal Diseases; Hypersensitivity; Arthritis
• Other Study ID Numbers: ARCR 2007/01; 2006-A00658-43

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No