Bone MicroArchitecture Abatacept (BMA2) (BMA2)
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|ClinicalTrials.gov Identifier: NCT02675218|
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : May 30, 2019
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.
|Condition or disease||Intervention/treatment|
|Arthritis, Rheumatoid||Other: Patients with rheumatoid arthritis|
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|
|Estimated Enrollment :||80 participants|
|Official Title:||Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)|
|Actual Study Start Date :||November 10, 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
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 Name: Doppler effect
- 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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02675218
|Contact: Hubert MAROTTE, PhDfirstname.lastname@example.org|
|Contact: Florence RANCON, CRAemail@example.com|
|Hôpital Édouard Herriot||Not yet recruiting|
|Lyon, France, 69000|
|Contact: Charline-Lucie ESTUBLIER, MD|
|Sub-Investigator: Roland CHAPURLAT, MD|
|Principal Investigator: Charline-Lucie ESTUBLIER, MD|
|Ch Regional D'Orleans||Not yet recruiting|
|Orleans, France, 45067|
|Contact: Eric LESPESSAILLES, MD|
|Principal Investigator: Eric LESPESSAILLES, MD|
|Sub-Investigator: Sylvie LOISEAU PERES, MD|
|Sub-Investigator: Carine SALLIOT, MD|
|Sub-Investigator: Emilie DUCOURAU, MD|
|Assistance Publique-Hopitaux de Paris||Not yet recruiting|
|Paris 04, France|
|Contact: Martine COHEN-SOLAL, MD|
|Principal Investigator: Martine COHEN-SOLAL, MD|
|Chu Saint Etienne||Recruiting|
|Saint-etienne, France, 42100|
|Contact: Hubert MAROTTE, PhD firstname.lastname@example.org|
|Principal Investigator: Hubert MAROTTE, PhD|
|CHU de Toulouse||Not yet recruiting|
|Toulouse 9, France, 31059|
|Contact: Alain CANTAGREL, MD|
|Principal Investigator: Alain CANTAGREL, MD|
|Sub-Investigator: Bénédicte JAMARD, MD|
|Sub-Investigator: Arnaud CONSTANTIN, MD|
|Sub-Investigator: Michel LAROCHE, MD|
|Sub-Investigator: Adeline RUYSSEN-WITRAND, MD|
|Principal Investigator:||Hubert MAROTTE, PhD||CHU SAINT ETIENNE|