Bone MicroArchitecture Abatacept (BMA2)

Arthritis, Rheumatoid Clinical Trial

— BMA2  

Official title:

Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02675218
• Other study ID #: 1508203
• Secondary ID: 2015-005644-33
• Status: Terminated
• Start date: November 10, 2016
• Est. completion date: June 4, 2019

Study information

• Verified date: July 2020
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: June 4, 2019
• Est. primary completion date: June 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid

Intervention

Other:
• Patients with rheumatoid arthritis
Doppler effect at 3 months after Abatacept treatment initiation.

Locations

Country	Name	City	State
France	Hôpital Édouard Herriot	Lyon
France	Ch Regional D'Orleans	Orleans
France	Assistance Publique-Hopitaux de Paris	Paris 04
France	Chu Saint Etienne	Saint-etienne
France	CHU de Toulouse	Toulouse 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Value of joint inflammation	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.	1 year