Rheumatoid ArthritisSEANCT00444691
Sensitivity of Echography in Arthritis
A study testing ultra-sonography in people with Rheumatoid Arthritis, run by Association de Recherche Clinique en Rhumatologie at 10 sites in 2 countries.
Trial summary
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis). An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands… 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?
- ultra-sonography
- Type of treatment
- Medical device
- How many people
- 120 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Mar 2007to Apr 2010
- 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
- Patients with rheumatoid arthritis meeting ACR criteria.
- Justifying anti-TNF alpha treatment (switch or first administration).
- To have at least 6 synovitis at the clinical examination necessary for the DAS evaluation
- To accept to participate in this study (informed consent signed).
Who cannot join
- Minor patients.
- Pregnancy.
- Breastfeeding.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
France9 sites
Hôpital Ambroise Paré
Boulogne, 92104
CHU de la Cavale Blanche
Brest, 29609
CHU Côte de Nacre
Caen, 14000
CHU A. Michallon
Grenoble, 38000
Hôpital Bicêtre
Le Kremlin-Bicêtre, 94275
Hôpital Cochin
Paris, 75006
Hôpital de la Pitié
Paris, 75013
CHU de RENNES - Hôpital Sud
Rennes, 35000
CHU Nancy-Brabois
Vandœuvre-lès-Nancy, 54511
About this study
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).
An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA).
Read more
It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments.
In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients.
Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).
Read the detailed description
This is a multicenter, (10 French centers and 1 Belgian center), prospective (4-month patients' follow-up) interventional study in 120 patients with rheumatoid arthritis justifying anti-TNF treatment.
The overall duration of the study will be 8 months composed of a 4-month inclusion period and a 4-month follow-up period for each patient. Moreover, X-ray evaluations of hands and feet will be performed 2 years from the beginning of the study in order to assess the changes in structural damage.
During the patients' participation, 6 visits are planned: an inclusion visit then, a follow-up visit at 1, 2 and 3 months from the inclusion visit, and a final evaluation visit at 4 months from the inclusion visit. At each visit, synovitis will be evaluated using both methods: clinical examination and ultrasonography. For a same patient, clinical evaluation of synovitis will have to be performed - during the entire study - by the same rheumatologist and the ultrasonographic evaluation will have to be performed by the same ultrasonographist (different from the rheumatologist) and always using the same ultrasonograph.
Finally, patients will be performed anterior X-rays of hands and feet two years from the beginning of the study whatever the ongoing RA treatment.
- Conditions
- Rheumatoid Arthritis
- Being tested
- ultra-sonography
- Keywords
- synovitis score, sensitivity to change, clinical examination, ultra-sonography
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultra-sonographyDevice
Also called scanners:, ESAOTE Technos MPX, TOSHIBA APLIO, ESAOTE MyLab
- The ultrasonographic evaluation was performed on 38 joints: the 28 joints included in DAS28 (e.g. shoulderx2, elbowx2, wristx2, metacarpo-phalangeal (MCP)x10, proximal inter phalangeal (PIP)x10, kneex2) and also the metatarso-phalangeal (MTPx10). Systematic multiplanar gray-scale (mode B) and Power Doppler examination was carried out with commercially available real-time scanners using multi-frequency linear transducers (7-12 MHz).
The ultrasonographic evaluation was performed at baseline and 1, 2, 3, and 4 months after baseline.
What is being measured
The primary outcome is the main question the study is designed to answer.
joint score evaluated by clinical examination
Measured: baseline and 1, 2, 3 and 4 months after baseline
joint score evaluated by ultra-sonography
Measured: baseline and 1, 2, 3 and 4 months after baseline
Secondary outcomes (2)
DAS28 Synovial index
Measured: baseline and 1, 2, 3 and 4 months after baseline
ACR Synovial index (66 sites)
Measured: baseline and 1, 2, 3 and 4 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2007 (estimated)
- Study startMar 2007
- Primary completionAug 2008
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- 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
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Association de Recherche Clinique en Rhumatologie
- Sponsor type
- University, hospital or other
- Collaborators
- RCTs
- Investigators
- Maxime DOUGADOS, Professor, Principal investigator, ARCR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00444691
- Sponsor's protocol ID
- ARCR 2007/01
- Other IDs
- 2006-A00658-43
- Acronym
- SEA
- Status last verified
- Aug 2009
- First submitted
- 7 Mar 2007
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chales G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.
PubMed 27042336
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity of Echography in Arthritis
- ClinicalTrials.gov ID
- NCT00444691
- Acronym / sponsor ID
- SEA / ARCR 2007/01
- Conditions
- Rheumatoid Arthritis
- Keywords
- synovitis score, sensitivity to change, clinical examination, ultra-sonography
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Association de Recherche Clinique en RhumatologieUniversity, hospital or other
- Collaborators
- RCTs
- Study start
- Mar 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Apr 2010 (estimated)
- First posted
- 8 Mar 2007 (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.
It has been reported recently that the detection of synovitis by ultrasonography was more sensitive than clinical examination (Wakefield et al. Ann Rheum Dis).
An OMERACT and EULAR working party recently produced guidelines on the best way to record and score quantitatively synovitis of the small joints of the hands and feet (Wakefield R, D'Agostino MA).
It has also been presumed recently that ultrasonography was more sensitive to changes than clinical examination after anti-TNF treatment (Ref. Taylor et al). If this better sensitivity to change were to be confirmed, ultrasonography would be preferred to clinical examination in studies evaluating new treatments.
In everyday practice, better intrinsic validity of the evaluation of synovitis by ultrasonography would lead to widespread use of this technique in the diagnosis and treatment of rheumatoid arthritis patients.
Objective of this study is to compare the sensitivity to change in synovitis score according to the monitoring method used (clinical examination versus ultrasonography).
Detailed description
This is a multicenter, (10 French centers and 1 Belgian center), prospective (4-month patients' follow-up) interventional study in 120 patients with rheumatoid arthritis justifying anti-TNF treatment.
The overall duration of the study will be 8 months composed of a 4-month inclusion period and a 4-month follow-up period for each patient. Moreover, X-ray evaluations of hands and feet will be performed 2 years from the beginning of the study in order to assess the changes in structural damage.
During the patients' participation, 6 visits are planned: an inclusion visit then, a follow-up visit at 1, 2 and 3 months from the inclusion visit, and a final evaluation visit at 4 months from the inclusion visit. At each visit, synovitis will be evaluated using both methods: clinical examination and ultrasonography. For a same patient, clinical evaluation of synovitis will have to be performed - during the entire study - by the same rheumatologist and the ultrasonographic evaluation will have to be performed by the same ultrasonographist (different from the rheumatologist) and always using the same ultrasonograph.
Finally, patients will be performed anterior X-rays of hands and feet two years from the beginning of the study whatever the ongoing RA treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with rheumatoid arthritis meeting ACR criteria.
- Justifying anti-TNF alpha treatment (switch or first administration).
- To have at least 6 synovitis at the clinical examination necessary for the DAS evaluation
- To accept to participate in this study (informed consent signed).
Key exclusion criteria (3 listed)
- Minor patients.
- Pregnancy.
- Breastfeeding.
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 |
|---|---|---|
| ultra-sonographyAlso: scanners:, ESAOTE Technos MPX, TOSHIBA APLIO, ESAOTE MyLabo The ultrasonographic evaluation was performed on 38 joints: the 28 joints included in DAS28 (e.g. shoulderx2, elbowx2, wristx2, metacarpo-phalangeal (MCP)x10, proximal inter phalangeal (PIP)x10, kneex2) and also the metatarso-phalangeal (MTPx10). Systematic multiplanar gray-scale (mode B) and Power Doppler examination was carried out with commercially available real-time scanners using multi-frequency linear transducers (7-12 MHz). The ultrasonographic evaluation was performed at baseline and 1, 2, 3, and 4 months after baseline. | Device | – |
Primary outcome
joint score evaluated by clinical examination
Time frame: baseline and 1, 2, 3 and 4 months after baseline
joint score evaluated by ultra-sonography
Time frame: baseline and 1, 2, 3 and 4 months after baseline
2 secondary outcomes
DAS28 Synovial index
Time frame: baseline and 1, 2, 3 and 4 months after baseline
ACR Synovial index (66 sites)
Time frame: baseline and 1, 2, 3 and 4 months after baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2009.
- Derived from this study: PubMed 27042336Cheung PP, Mari K, Devauchelle-Pensec V, Jousse-Joulin S, D'Agostino MA, Chales G, Gaudin P, Mariette X, Saraux A, Dougados M. Predictive value of tender joints compared to synovitis for structural damage in rheumatoid arthritis. RMD Open. 2016 Mar 17;2(1):e000205. doi: 10.1136/rmdopen-2015-000205. eCollection 2016.
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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.
Maxime DOUGADOS, Professor principal investigator
ARCR
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ultra-sonography in people with Rheumatoid Arthritis, run by Association de Recherche Clinique en Rhumatologie at 10 sites in 2 countries.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, Belgium. 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?
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?
joint score evaluated by clinical examination (time frame: baseline and 1, 2, 3 and 4 months after baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00444691, which also lists 1 linked publication.
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 26 Aug 2009.