Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00444691
Status:
UNKNOWN
Last Update Posted:
2009-08-26
First Post:
2007-03-07
Brief Title:
Sensitivity of Echography in Arthritis
Sponsor:
Association de Recherche Clinique en Rhumatologie
Organization:
Association de Recherche Clinique en Rhumatologie
Study Overview
Official Title:
Sensitivity of Echography in Arthritis
Status:
UNKNOWN
Status Verified Date:
2009-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEA
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 DAgostino 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
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 DAgostino 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-A00658-43 | None | None | None |