Bone MicroArchitecture Abatacept (BMA2)

Terminated

• Conditions: Arthritis, Rheumatoid
• Interventions: Other: Patients with rheumatoid arthritis

• Registration Number: NCT02675218
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

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.

Study Timeline

• Study First Submitted: 2016-01-26
• Study First Submitted QC: 2016-02-02
• Study First Posted: 2016-02-05
• Study Start: 2016-11-10
• Primary Completion: 2019-06-04
• Study Completion: 2019-06-04
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-22
• Last Update Posted: 2020-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with rheumatoid arthritis.	Patients with rheumatoid arthritis	Rheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria.

Primary Outcome Measures

Name	Time	Method
Value of joint inflammation	1 year	The predictive value of persistent joint inflammation on volumetric trabecular bone density is measured by high resolution pQCT (peripheral Quantitative Computed Tomography) after 1 year treatment with Abatacept.

Trial Locations

Locations (5)

Chu Saint Etienne; 🇫🇷 Saint-etienne, France

CHU de Toulouse; 🇫🇷 Toulouse 9, France

Hôpital Édouard Herriot; 🇫🇷 Lyon, France

Ch Regional D'Orleans; 🇫🇷 Orleans, France

Assistance Publique-Hopitaux de Paris; 🇫🇷 Paris 04, France