Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Bone MicroArchitecture Abatacept (BMA2) (BMA2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02675218
Recruitment Status : Recruiting
First Posted : February 5, 2016
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment
Arthritis, Rheumatoid 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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

Drug Information available for: Abatacept

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 Name: Doppler effect




Primary Outcome Measures :
  1. 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
Blood samples will be performed to determine the predictive value of joint inflammation.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Hubert MAROTTE, PhD hubert.marotte@univ-st-etienne.fr
Contact: Florence RANCON, CRA florence.rancon@chu-st-etienne.fr

Locations
Layout table for location information
France
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       hubert.marotte@univ-st-etienne.fr   
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         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Layout table for investigator information
Principal Investigator: Hubert MAROTTE, PhD CHU SAINT ETIENNE

Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02675218     History of Changes
Other Study ID Numbers: 1508203
2015‐005644‐33 ( EudraCT Number )
First Posted: February 5, 2016    Key Record Dates
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Connective Tissue Diseases
Abatacept
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Autoimmune Diseases
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents