Description of Spondylarthritis and Validation of ASAS Criteria in West Indian Patients Seen in Consultation of Rheumatology. (SPACA)
|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: NCT03564743|
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 23, 2019
In 2004 an ASAS for the Assessment of SpondyloArthritis International Society decided to work to improve the criteria for classification of spondyloarthropathies to allow for early diagnosis, Nuclear magnetic resonance imaging (MRI). This approach led to the publication in 2009 of the classification criteria for spondylarthritis, in particular axial spondyloarthritis, as well as a proposal to modify the classification of criteria defined by Mr. Amor (AMOR) and European Spondylarthropathy Study Group (ESSG) criteria, taking into account the potential abnormalities visible in Magnetic Resonance Imaging Nuclear (MRI).
The performance (specificity, sensitivity, positive and negative predictive values) of the ASAS criteria was then prospectively tested on a sample of the Metropolitan Caucasian population and this systematic study allowed to estimate the performance of the ASAS criteria in the usual framework Of the French Liberal Rheumatology Consultation.
Note that this approach is exposed to a criticism of "circular" approach, indeed the expert who is the gold standard for the diagnosis, uses more or less consciously "criteria" based on the presence of such and such sign, then checks in this selected population the diagnostic validity of these signs.
However, no data on the performance of ASAS criteria are available in populations of African descent.
|Condition or disease||Intervention/treatment|
|Spondyloarthritis||Diagnostic Test: Evaluation of ASAS criteria|
Historically, spondyloarthritis is considered rare in these populations in the image of human Leukocyte Antigen B27 (HLA B27) which is observed only in 0.3% of individuals. Its presence determines the appearance of sacroiliitis - the cardinal sign of the disease - which is therefore rare. The recent contribution of MRI has changed investigators point of view and makes it possible to make the diagnosis in frequent situations but more atypical clinically.
- ASAS signs are not systematically found in the West Indies (sacroiliitis, uveitis, cervicitis, urethritis, inflammatory syndrome, HLAB27 ...)
- Apart from cases associated with Chronic Inflammatory Bowel Disease (IBD), clinical panels are atypical and the ASAS criteria for little help
- MRI imaging is used to correct diagnosis. It is therefore necessary to describe these patients and to study the interest of the ASAS criteria in this population On the other hand, the validation of the ASAS criteria is part of the recommendations of treatment of the SPA (spondyloarthritis) by the French Society of Rheumatology in 2014. Clearly a patient who does not validate these criteria does not have access to anti- tumor necrosis factor (TNF) biotherapies, effective but Expensive. Thus, it is not known whether West Indian patients validate these criteria or not, but it is clear that despite the large number of local SPAs, few receive anti-TNF biotherapies.
The investigators propose to describe a population of Caribbean spondyloarthritis through a cross-sectional observational study carried out with a sample of rheumatologist doctors in three sites (Martinique, Guadeloupe, French Guyana). The methodology of the cluster survey of physicians, with a systematic evaluation of the first patients seen in consultation (chronological selection) provides the best guarantee of representativeness.
The interest of this work is to reproduce exactly the methodology of a previous work carried out in a Caucasian population, validated and published, and thus be able to compare the value of the ASAS criteria between the Caucasian and Caribbean populations.
|Study Type :||Observational|
|Estimated Enrollment :||220 participants|
|Official Title:||Clinical Description of Spondylarthritis and Validation of Assessment of SpondyloArthritis International Society (ASAS) Criteria in West Indian Patients Seen in the Routine Consultation of Rheumatology.|
|Actual Study Start Date :||September 2015|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||December 2019|
- Diagnostic Test: Evaluation of ASAS criteria
Perform ASAS criteria at the time of physician diagnosis of chronic low back pain in rheumatological practice.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: September 2018 ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0, Change From Baseline in Pain Scores on the Visual Analog Scale at 6 Weeks.
- ASAS criteria [ Time Frame: September 2018 ]Assess the performance of ASAS criteria (sensitivity, specificity, positive predictive value, negative predictive value) at the time of physician's diagnosis of chronic low back pain in rheumatological practice (Evaluation of the concept of "diagnostic criteria" and Classification criteria).
- Assessment and comparison of ASAS performance against other classifications [ Time Frame: September 2018 ]Performance calculation of other classification systems (ESSG, Amor, New York modified): sensitivity, specificity, positive and negative predictive values.
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): NCT03564743
|Contact: Michel MD De Bandt, PHD||0596 55 23 31 ext +firstname.lastname@example.org|
|Contact: Marie MB Blettery, MD||0596 55 23 31 ext +email@example.com|
|CHU de Martinique||Recruiting|
|Fort-de-France, Martinique, 97261|
|Contact: Véronique Mr ERDUAL 0596592696 ext +596 firstname.lastname@example.org|
|Principal Investigator: Michel Mr De Bandt, PHD|
|Principal Investigator:||Michel MD De Bandt||CHU de Martinique|