Ignite Creation Date:
2025-12-25 @ 4:36 AM
Ignite Modification Date:
2026-03-05 @ 6:04 PM
Study NCT ID:
NCT02675218
Status:
TERMINATED
Last Update Posted:
2020-07-24
First Post:
2016-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bone MicroArchitecture Abatacept (BMA2)
Sponsor:
Centre Hospitalier Universitaire de Saint Etienne
Organization:
Study Overview
Official Title:
Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)
Status:
TERMINATED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No more inclusion
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BMA2
Brief Summary:
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs).
Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.
Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.
Detailed Description:
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying anti-rheumatic drugs. In patients responding insufficiently to Methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARD) strategies, with or without glucocorticoids, biological DMARD (TNF inhibitors, abatacept or tocilizumab, and, under certain circumstances, rituximab) should be commenced with Methotrexate. Among DMARD available in 2015, abatacept has demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction. Monitoring rheumatoid arthritis patients after starting abatacept by US exams observed a strong reduction of power Doppler ultra-sonography at 3 months in two third of patients.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept initiation.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept initiation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-005644-33 | EUDRACT_NUMBER | None | View |