Sensitivity of Echography in Arthritis (SEA)
Recruitment status was Active, not recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 ]
- 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) |
-
Device: ultra-sonography
- scanners:
- ESAOTE Technos MPX
- TOSHIBA APLIO
- ESAOTE MyLab
- PHILIPS HD11
- BK Mini Focus.
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.
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 |
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| 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 de la Pitié | |
| Paris, France, 75013 | |
| Hôpital Cochin | |
| Paris, France, 75006 | |
| CHU de RENNES - Hôpital Sud | |
| Rennes, France, 35000 | |
| CHU Nancy-Brabois | |
| Vandoeuvre Les Nancy, France, 54511 | |
| 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 Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013