Clinical trial NCT02675218: Bone MicroArchitecture Abatacept (BMA2)
Official title: Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthritis, Rheumatoid
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients diagnosed according to ACR/EULAR 2010 criteria, and Abatacept therapy sub-cutaneous required according EULAR recommendation.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Value of joint inflammation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital Édouard Herriot
city: Orleans
country: France
facility: Ch Regional D'Orleans
city: Paris 04
country: France
facility: Assistance Publique-Hopitaux de Paris
city: Saint-etienne
country: France
facility: Chu Saint Etienne
city: Toulouse 9
country: France
facility: CHU de Toulouse
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Hubert MAROTTE, PhD
role: PRINCIPAL_INVESTIGATOR
References: