Clinical Trials Directory

Trials / Terminated

TerminatedNCT02675218

Bone MicroArchitecture Abatacept (BMA2)

Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)

Status
Terminated
Phase
Study type
Observational
Enrollment
13 (actual)
Sponsor
Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
OTHERPatients with rheumatoid arthritisDoppler effect at 3 months after Abatacept treatment initiation.

Timeline

Start date
2016-11-10
Primary completion
2019-06-04
Completion
2019-06-04
First posted
2016-02-05
Last updated
2020-07-24

Locations

5 sites across 1 country: France

Source: ClinicalTrials.gov record NCT02675218. Inclusion in this directory is not an endorsement.