Bone MicroArchitecture Abatacept (BMA2)

Overview

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 Title of Study: “Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2020

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Value of joint inflammation
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Centre Hospitalier Universitaire de Saint Etienne
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hubert MAROTTE, PhD, Principal Investigator, CHU SAINT ETIENNE
  • Overall Contact(s)
    • Hubert MAROTTE, PhD, hubert.marotte@univ-st-etienne.fr

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.