Bone MicroArchitecture Abatacept (BMA2)

Centre Hospitalier Universitaire de Saint Etienne

Status: Terminated

Conditions: Arthritis, Rheumatoid

Treatments: Other: Patients with rheumatoid arthritis

Study type: Observational

Funder types: Other

Identifiers

NCT02675218

1508203

2015-005644-33 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed and dated informed consent form,
• Age ≥ 18 years,
• Rheumatoid arthritis diagnosis according to ACR/EULAR 2010 criteria
• Abatacept therapy sub-cutaneous required according EULAR recommendations
• Patients affiliated to health insurance

Exclusion criteria

• Other arthritis than rheumatoid arthritis,
• Contraindication to abatacept,
• Concomitant treatment with zoledronic acid (Aclasta®) or denosumab (Prolia®),
• Injection intravenously or intra-articular at the 2nd and 3rd metacarpophalangeal joint of the dominant hand during the 3 months prior to inclusion,
• Prior or planned joint surgery at the 2nd or 3rd metacarpophalangeal joint of the dominant hand over the one year study,
• No recent used of high density contrast material,
• Pregnancy or breastfeeding.

Trial design

13 participants in 1 patient group

Patients with rheumatoid arthritis.

Description:

Rheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria.

Treatment:

Other: Patients with rheumatoid arthritis