Rheumatoid ArthritisNCT02531061
Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy
A study testing HR-pQCT in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some criteria were already proposed and the last one was proposed in 2011. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- HR-pQCT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 2 sitesFrance
- Study dates
- 5 May 2013to 29 Nov 2017
- Phase
- Interventional
- 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
Who may be able to join
- Initial medical examination performed,
- RA diagnosis according to the criteria of the ACR / EULAR 2010
- Low or moderate disease activity with a DAS28 ≤ 4 since at least for 6 months
- Patients with bDMARDs (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, ou Orencia®) since at least 6 months and no change planned by the investigator,
- Patient with at least one erosion on the head of the 2nd or 3rd metacarpal right or left,
- Stable corticosteroids dose since at least 3 months less than or equal to 10 mg of prednisone equivalent,
- Medical care and monitoring in the rheumatology department of the CHU of Saint-Etienne or the Edouard Herriot Hospital in Lyon,
- written consent of patient
Who cannot join
- Other diagnosis than RA,
- Intravenous or intra-articular injection at the 2nd or 3rd metacarpophalangeal left or right during the 3 months prior to inclusion,
- Surgery provided at the 2nd or 3rd metacarpophalangeal right or left within a year of inclusion,
- Concomitant treatment with zoledronic acid (Aclasta) or denosumab (Prolia®)
- Refusal of blood collection,
- Pregnancy or breastfeeding women,
Trial locations and contacts
2 sites in 1 country.
France2 sites
HCL - Hôpital EdouarD Herriot
Lyon
CHU Saint-Etienne
Saint-Etienne, 42055
About this study
Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some criteria were already proposed and the last one was proposed in 2011.
All these criteria integrated only clinical criteria without imaging assessment. In this context, ultrasound joint is daily performed without definition of remission. A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage. A definition of remission in RA could include erosions regression in subchondral bone (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)).
Read more
The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion.
Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage (progression of radiographic lesions). Recent data showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is a new technique emerging for bone erosions assessment in RA. Erosions size and volume could be reduced with anti-TNF, but with a large interindividual variability. There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT.
- Conditions
- Rheumatoid Arthritis
- Being tested
- HR-pQCT
- Keywords
- Rheumatoid Arthritis, bDMARDs, biotherapy, remission, erosion
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HR-pQCTDevice
Also called Xtrem CT scanco
The Xtrem CT scanco device is a HR-pQCT. It was initially used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body.
For the study, the device will be used to measure changes in erosion at the 2nd or 3rd metacarpal head. Only the patient's hand will be in contact with the medical device, the acquisition time will be 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| active erosion | Experimental | HR-pQCT for measure bone parameters in "active erosion" group. The "active erosion" group will be defined by grades 2 and 3, ie by the presence of Doppler signals confluence in less than 50% of the synovial surface (grade 2) and in over 50% of the surface synovial for grade 3 Receives: Device: HR-pQCT |
| inactive erosion | Experimental | HR-pQCT for measure bone parameters in "active erosion" group. The "inactive erosion" group will be defined by grades 0 and 1, ie the absence of Doppler signal for grade 0 and the presence of some non confluence Doppler signals for the grade 1 Receives: Device: HR-pQCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in depth of the erosion
compare the change in the depth of the erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).
Measured: baseline from 1 year
Secondary outcomes (3)
Change in volume of erosion
compare the change in volume of erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).
Measured: baseline from 1 year
Change in width of erosion
compare the change in width of erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).
Measured: baseline from 1 year
Change in density parameter of bone microarchitecture
compare the change in density parameter of bone microarchitecture of erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®). Density parameter of bone microarchitecture is a composite outcome : Total mineral volumetric density (mg/ccm HA), Trabéculaire mineral volumetric density (mg/ccm HA), Cortical mineral volumetric density (mg/ccm HA), Trabecular Number (1/mm), Trabecular thickness (mm), Trabecular Separation (mm), Mean distance between trabeculae (mm), Presence of new erosions and volume
Measured: baseline from 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2015 (estimated)
- Study start5 May 2013
- Primary completion29 Nov 2017
- Study completion29 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Hubert Marotte, PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531061
- Sponsor's protocol ID
- 1208092
- Other IDs
- 2012-A01583-40
- Status last verified
- Oct 2018
- First submitted
- 20 Aug 2015
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Persistence of Inflammation at Doppler Ultrasound Level on the Structural Evolution of Erosion in Rheumatoid Arthritis Treated With Biotherapy
- ClinicalTrials.gov ID
- NCT02531061
- Acronym / sponsor ID
- 1208092
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, bDMARDs, biotherapy, remission, erosion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 5 May 2013 (actual)
- Primary completion
- 29 Nov 2017 (actual)
- Study completion
- 29 Nov 2017 (actual)
- First posted
- 21 Aug 2015 (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.
Since biological disease-modifying anti-rheumatic drugs (bDMARDs) are available in rheumatoid arthritis (RA) strategy an emerging question is the definition of remission in RA. Today some criteria were already proposed and the last one was proposed in 2011.
All these criteria integrated only clinical criteria without imaging assessment. In this context, ultrasound joint is daily performed without definition of remission. A discrepancy exists between clinical remission and persistence of active disease with ultrasound joint presence of a Doppler effect indicating inflammation and the risk of progression of joint damage. A definition of remission in RA could include erosions regression in subchondral bone (at best measured by high resolution peripheral quantitative computed tomography (HR-pQCT)).
The main hypothesis is that the reduction of erosion size assessed by HR-pQCT will be observed only in the absence of local inflammation measured by Doppler ultrasound in the erosion.
Tumor Necrosis Factor (TNF) blockers have strongly improved RA therapy outcome in terms of clinical improvement and structural damage (progression of radiographic lesions). Recent data showed that there could be joint bone rebuilt in case of inflammation suppression. HR-pQCT is a new technique emerging for bone erosions assessment in RA. Erosions size and volume could be reduced with anti-TNF, but with a large interindividual variability. There was no correlation between the activity of clinical or ultrasound synovium and evolution of erosion HR-pQCT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active erosion | Experimental | Device: HR-pQCTHR-pQCT for measure bone parameters in "active erosion" group. The "active erosion" group will be defined by grades 2 and 3, ie by the presence of Doppler signals confluence in less than 50% of the synovial surface (grade 2) and in over 50% of the surface synovial for grade 3 |
| inactive erosion | Experimental | Device: HR-pQCTHR-pQCT for measure bone parameters in "active erosion" group. The "inactive erosion" group will be defined by grades 0 and 1, ie the absence of Doppler signal for grade 0 and the presence of some non confluence Doppler signals for the grade 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Initial medical examination performed,
- RA diagnosis according to the criteria of the ACR / EULAR 2010
- Low or moderate disease activity with a DAS28 ≤ 4 since at least for 6 months
- Patients with bDMARDs (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, ou Orencia®) since at least 6 months and no change planned by the investigator,
- Patient with at least one erosion on the head of the 2nd or 3rd metacarpal right or left,
Key exclusion criteria (6 listed)
- Other diagnosis than RA,
- Intravenous or intra-articular injection at the 2nd or 3rd metacarpophalangeal left or right during the 3 months prior to inclusion,
- Surgery provided at the 2nd or 3rd metacarpophalangeal right or left within a year of inclusion,
- Concomitant treatment with zoledronic acid (Aclasta) or denosumab (Prolia®)
- Refusal of blood collection,
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 |
|---|---|---|
| HR-pQCTAlso: Xtrem CT scancoThe Xtrem CT scanco device is a HR-pQCT. It was initially used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body. For the study, the device will be used to measure changes in erosion at the 2nd or 3rd metacarpal head. Only the patient's hand will be in contact with the medical device, the acquisition time will be 3 minutes. | Device | active erosion, inactive erosion |
Primary outcome
Change in depth of the erosion
Time frame: baseline from 1 year
compare the change in the depth of the erosion of the second or third metacarpal head right or left at 12 months between patients with "active erosion" and those with "inactive erosion" in RA patients with low disease activity treated with bDMARD since at least 6 months (Remicade®, Enbrel®, Humira®, Cimzia®, Simponi®, Ro-Actemra®, or Orencia®).
3 secondary outcomes
Change in volume of erosion
Time frame: baseline from 1 year
Change in width of erosion
Time frame: baseline from 1 year
Change in density parameter of bone microarchitecture
Time frame: baseline from 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HR-pQCT in people with Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Saint Etienne at 2 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 8 inclusion and 6 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: finished, as of the sponsor's last update on 29 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in depth of the erosion (time frame: baseline from 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 29 Oct 2018.