Bone MicroArchitecture Abatacept (BMA2) (BMA2)

Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)

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.

Study Overview

• Status: Terminated
• Conditions: Arthritis, Rheumatoid
• Intervention / Treatment: Other: Patients with rheumatoid arthritis

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 Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69000
    • Hôpital Edouard Herriot
  • Orleans, France, 45067
    • Ch Regional D'Orleans
  • Paris 04, France
    • Assistance Publique-Hôpitaux de Paris
  • Saint-etienne, France, 42100
    • CHU Saint Etienne
  • Toulouse 9, France, 31059
    • CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with rheumatoid arthritis.; Rheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria.	Other: Patients with rheumatoid arthritis; Doppler effect at 3 months after Abatacept treatment initiation.; Other Names: Doppler effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Hubert MAROTTE, PhD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2016
• Primary Completion (Actual): June 4, 2019
• Study Completion (Actual): June 4, 2019

Study Registration Dates

• First Submitted: January 26, 2016
• First Submitted That Met QC Criteria: February 2, 2016
• First Posted (Estimate): February 5, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2020
• Last Update Submitted That Met QC Criteria: July 22, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 1508203; 2015-005644-33 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No