SpondylarthropathyEchoSpANCT00794404
Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy
An observational study of Spondylarthropathy and Ankylosing Spondyloarthitis, run by Dr Maria-Atonietta D'AGOSTINO at 6 sites in France.
Trial summary
The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondylarthropathy, Ankylosing Spondyloarthitis, Spondyloarthritis
- How many people
- 489 participants
- Where
- 6 sitesFrance
- Study dates
- Dec 2004to Dec 2010
- 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: Patients with a symptomatology which can lead to a SPA diagnosis but with no confirmed diagnosis yet for any rheumatic didease.
Who may be able to join
- patients < 50 years old, consulting for spinal inflammatory symptoms > 3 months duration
- patients consulting for arthritis or tenderness joints > 3 months duration
- patients < 50 years old consulting for enthesitis or dactylitis > 3 months duration
- patients with uveitis and HLA-B27 positivity
- relatives of SpA patients consulting for symptoms suggestive of SpA
Who cannot join
- patient with confirmed diagnosis of rheumatic disease (included SpA)
- patient protected by law (patient <18 years old, pregnant woman)
- patient who can't atempt the RMI
- patient who will have difficulties to complete the two years of follow-up
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Ambroise Paré Hospital
Boulogne-Billancourt, 92100
Cavale Blanche Hospital
Brest, 29200
Cote de Nacre Hospital
Caen, 14033
South Hospital of Grenoble
Échirolles, 38434
Conception Hospital
Marseille, 13005
Nancy Brabois Hospital
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy
The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis
Read the detailed description
Spondylarthritis (SPA) are the second most frequent inflammatory rheumatic disorders and, because it starts early in life and has a chronic progressive course, the impact of this disease on health resources and patient's life quality can be important. Because the characteritic signs of SPA, like radiological evidence of sacro-iliitis, appear late in time, the lag time between the onset first signs of SPA for the patient and the confirmed diagnosis can be very long (up to 8 years). Previous studies proved that patients who are affected by SPA are showing abnormal vascularization of peripheral enthesis more frequently than patients affected by other rheumatic diseases. Ultrasonography in B mode combined with power Doppler (PDUS) is a non invasive and highly sensitive toll which can detect enthesitis and abnormal vsacularization even for the patients who are not showing yet the evidence of SPA's symptomatology. Using PDUS as a early diagnosis tool could lead to the improvement of diagnostic procedures and therapeutic management of SpA and reduce the cost of diagnosis for patient and health insurances.
- Medical subject headings
- Spondylarthropathies, Spondylarthritis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startDec 2004
- Primary completionMar 2010
- Study completionDec 2010
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 SpondylarthropathyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 489 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Maria-Atonietta D'AGOSTINO
- Sponsor type
- University, hospital or other
- Collaborators
- Groupe Français d'Etude Génétique des Spondylarthropathies, French Society of Rheumatology
- Responsible party
- Sponsor-investigator, Dr Maria-Atonietta D'AGOSTINO, Groupe Français d'Etude Génétique des Spondylarthropathies
- Investigators
- D'AGOSTINO Maria-Antonietta, MCUPH, Principal investigator, Ambroise Paré Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794404
- Sponsor's protocol ID
- GESPA
- Acronym
- EchoSpA
- Status last verified
- Nov 2008
- First submitted
- 19 Nov 2008
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Devauchelle-Pensec V, D'Agostino MA, Marion J, Lapierre M, Jousse-Joulin S, Colin D, Chary-Valckenaere I, Marcelli C, Loeuille D, Aegerter P, Guis S, Gaudin P, Breban M, Saraux A; Study Group of Spondylarthritis. Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: results of a prospective multicenter French cohort study. Arthritis Rheum. 2012 May;64(5):1412-9. doi: 10.1002/art.33466.
PubMed 22081446
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Power Doppler US Technique for the Diagnosis of Spondylarthropathy in Patients With Uncertain Diagnosis Consulting for Clinical Symptoms Suggestive of Spondylarthropathy
- ClinicalTrials.gov ID
- NCT00794404
- Acronym / sponsor ID
- EchoSpA / GESPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 489 participants (actual)
- Lead sponsor
- Dr Maria-Atonietta D'AGOSTINOUniversity, hospital or other
- Collaborators
- Groupe Français d'Etude Génétique des Spondylarthropathies, French Society of Rheumatology
- Study start
- Dec 2004
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 20 Nov 2008 (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.
The purpose of this study is to evaluate the interest of enthesis sonography for the diagnosis of spondylarthritis, in patients with uncertain diagnosis consulting for clinical symptoms suggestive of spondylarthritis
Detailed description
Spondylarthritis (SPA) are the second most frequent inflammatory rheumatic disorders and, because it starts early in life and has a chronic progressive course, the impact of this disease on health resources and patient's life quality can be important. Because the characteritic signs of SPA, like radiological evidence of sacro-iliitis, appear late in time, the lag time between the onset first signs of SPA for the patient and the confirmed diagnosis can be very long (up to 8 years). Previous studies proved that patients who are affected by SPA are showing abnormal vascularization of peripheral enthesis more frequently than patients affected by other rheumatic diseases. Ultrasonography in B mode combined with power Doppler (PDUS) is a non invasive and highly sensitive toll which can detect enthesitis and abnormal vsacularization even for the patients who are not showing yet the evidence of SPA's symptomatology. Using PDUS as a early diagnosis tool could lead to the improvement of diagnostic procedures and therapeutic management of SpA and reduce the cost of diagnosis for patient and health insurances.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a symptomatology which can lead to a SPA diagnosis but with no confirmed diagnosis yet for any rheumatic didease.
Key inclusion criteria (5 listed)
- patients < 50 years old, consulting for spinal inflammatory symptoms > 3 months duration
- patients consulting for arthritis or tenderness joints > 3 months duration
- patients < 50 years old consulting for enthesitis or dactylitis > 3 months duration
- patients with uveitis and HLA-B27 positivity
- relatives of SpA patients consulting for symptoms suggestive of SpA
Key exclusion criteria (4 listed)
- patient with confirmed diagnosis of rheumatic disease (included SpA)
- patient protected by law (patient <18 years old, pregnant woman)
- patient who can't atempt the RMI
- patient who will have difficulties to complete the two years of follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 31 Oct 2016.
- Derived from this study: PubMed 22081446Devauchelle-Pensec V, D'Agostino MA, Marion J, Lapierre M, Jousse-Joulin S, Colin D, Chary-Valckenaere I, Marcelli C, Loeuille D, Aegerter P, Guis S, Gaudin P, Breban M, Saraux A; Study Group of Spondylarthritis. Computed tomography scanning facilitates the diagnosis of sacroiliitis in patients with suspected spondylarthritis: results of a prospective multicenter French cohort study. Arthritis Rheum. 2012 May;64(5):1412-9. doi: 10.1002/art.33466.
- Individual participant dataSharing planned: No
Related trials for Spondylarthropathy
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Not yet recruitingPhase 2
Phase 2 Trial of FT2109 for the Treatment of Psoriatic Arthritis
Psoriatic Arthritis (PsA)
Active, not recruiting
Employment and Arthritis: Making it Work
Rheumatoid Arthritis, Ankylosing Spondylitis
Recruiting
Evolution of Intestinal Microbiota in Patients With Juvenile Spondylarthropathy According to Typology of Treatment
Spondylarthropathies
RecruitingObservational study
Molecular Inflammation Board at the Center for Personalized Medicine
Psoriasis (PsO), Psoriasis Arthritis
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.
D'AGOSTINO Maria-Antonietta, MCUPH principal investigator
Ambroise Paré Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondylarthropathy and Ankylosing Spondyloarthitis, run by Dr Maria-Atonietta D'AGOSTINO at 6 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 4 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 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794404, 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 31 Oct 2016; AzTrials last refreshed its copy on 7 Nov 2026.