Arthritis, RheumatoidBMA2NCT02675218
Bone MicroArchitecture Abatacept (BMA2)
An observational study of Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthritis, Rheumatoid
- What is being tested?
- Patients with rheumatoid arthritis
- How many people
- 13 participants
- Where
- 5 sitesFrance
- Study dates
- 10 Nov 2016to 4 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rheumatoid arthritis patients diagnosed according to ACR/EULAR 2010 criteria, and Abatacept therapy sub-cutaneous required according EULAR recommendation.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Hôpital Édouard Herriot
Lyon, 69000
Ch Regional D'Orleans
Orléans, 45067
Assistance Publique-Hopitaux de Paris
Paris
Chu Saint Etienne
Saint-Etienne, 42100
CHU de Toulouse
Toulouse, 31059
About this study
Official title: 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.
Read the 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.
- Conditions
- Arthritis, Rheumatoid
- Being tested
- Patients with rheumatoid arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with rheumatoid arthritisOther
Also called Doppler effect
Doppler effect at 3 months after Abatacept treatment initiation.
| Study group | Role | What they receive |
|---|---|---|
| Patients with rheumatoid arthritis. | Rheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria. Receives: Other: Patients with rheumatoid arthritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start10 Nov 2016
- Primary completion4 Jun 2019
- Study completion4 Jun 2019
Why it stopped: No more inclusion
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthritis, RheumatoidStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hubert MAROTTE, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675218
- Sponsor's protocol ID
- 1508203
- Other IDs
- 2015-005644-33, 2015
- Acronym
- BMA2
- Status last verified
- Jul 2020
- First submitted
- 26 Jan 2016
- Last updated
- 24 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone MicroArchitecture Abatacept in Rheumatoid Arthritis Patients (BMA2)
- ClinicalTrials.gov ID
- NCT02675218
- Acronym / sponsor ID
- BMA2 / 1508203
- Conditions
- Arthritis, Rheumatoid
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: No more inclusion
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 10 Nov 2016 (actual)
- Primary completion
- 4 Jun 2019 (actual)
- Study completion
- 4 Jun 2019 (actual)
- First posted
- 5 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with rheumatoid arthritis. | – | Other: Patients with rheumatoid arthritisRheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rheumatoid arthritis patients diagnosed according to ACR/EULAR 2010 criteria, and Abatacept therapy sub-cutaneous required according EULAR recommendation.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with rheumatoid arthritisAlso: Doppler effectDoppler effect at 3 months after Abatacept treatment initiation. | Other | Patients with rheumatoid arthritis. |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: No more inclusion). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hubert MAROTTE, PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthritis, Rheumatoid, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: No more inclusion). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Value of joint inflammation (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.