- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT00444691
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).
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
-
Bruxelles, Belgien, 1020
- Chu-Brugmann
-
-
-
-
-
Boulogne, Frankrike, 92104
- Hôpital Ambroise Paré
-
Brest, Frankrike, 29609
- CHU de la Cavale Blanche
-
Caen, Frankrike, 14000
- CHU côte de Nacre
-
Grenoble, Frankrike, 38000
- CHU A. Michallon
-
Le Kremlin Bicetre, Frankrike, 94275
- Hôpital Bicêtre
-
Paris, Frankrike, 75006
- Hôpital Cochin
-
Paris, Frankrike, 75013
- Hôpital de la Pitié
-
Rennes, Frankrike, 35000
- CHU de Rennes - Hôpital Sud
-
Vandoeuvre Les Nancy, Frankrike, 54511
- CHU Nancy-Brabois
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
joint score evaluated by clinical examination
Tidsram: baseline and 1, 2, 3 and 4 months after baseline
|
baseline and 1, 2, 3 and 4 months after baseline
|
joint score evaluated by ultra-sonography
Tidsram: baseline and 1, 2, 3 and 4 months after baseline
|
baseline and 1, 2, 3 and 4 months after baseline
|
Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
DAS28 Synovial index
Tidsram: baseline and 1, 2, 3 and 4 months after baseline
|
baseline and 1, 2, 3 and 4 months after baseline
|
ACR Synovial index (66 sites)
Tidsram: baseline and 1, 2, 3 and 4 months after baseline
|
baseline and 1, 2, 3 and 4 months after baseline
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Maxime DOUGADOS, Professor, ARCR
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ARCR 2007/01
- 2006-A00658-43
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
produkt tillverkad i och exporterad från U.S.A.
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på ultra-sonography
-
Yonsei UniversityOkändAllmän anestesiKorea, Republiken av
-
Sohag UniversityHar inte rekryterat ännu