Ignite Creation Date:
2024-05-06 @ 7:25 AM
Last Modification Date:
2024-10-26 @ 11:48 AM
Study NCT ID:
NCT02531061
Status:
COMPLETED
Last Update Posted:
2018-10-29
First Post:
2015-08-20
Brief Title:
Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Centre Hospitalier Universitaire de Saint Etienne
Study Overview
Official Title:
Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy
Status:
COMPLETED
Status Verified Date:
2018-10
Last Known Status:
None
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:
None
Brief Summary:
Since biological disease-modifying anti-rheumatic drugs bDMARDs are available in rheumatoid arthritis RA strategy an emerging question is the definition of remission in RA Today some criteria were already proposed and the last one was proposed in 2011
All these criteria integrated only clinical criteria without imaging assessment In this context ultrasound joint is daily performed without definition of remission A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage A definition of remission in RA could include erosions regression in subchondral bone at best measured by high resolution peripheral quantitative computed tomography HR-pQCT
The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion
Tumor Necrosis Factor TNF blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage progression of radiographic lesions Recent data showed that there could be joint bone rebuilt in case of inflammation suppression HR-pQCT is a new technique emerging for bone erosions assessment in RA Erosions size and volume could be reduced with anti-TNF but with a large interindividual variability There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT
All these criteria integrated only clinical criteria without imaging assessment In this context ultrasound joint is daily performed without definition of remission A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage A definition of remission in RA could include erosions regression in subchondral bone at best measured by high resolution peripheral quantitative computed tomography HR-pQCT
The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion
Tumor Necrosis Factor TNF blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage progression of radiographic lesions Recent data showed that there could be joint bone rebuilt in case of inflammation suppression HR-pQCT is a new technique emerging for bone erosions assessment in RA Erosions size and volume could be reduced with anti-TNF but with a large interindividual variability There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT
Detailed Description:
None
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 |
|---|---|---|---|
| 2012-A01583-40 | OTHER | ANSM | None |