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Trial record 2 of 4 for:    1930310 [PUBMED-IDS]

Description of Spondylarthritis and Validation of ASAS Criteria in West Indian Patients Seen in Consultation of Rheumatology. (SPACA)

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ClinicalTrials.gov Identifier: NCT03564743
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital Center of Martinique

Brief Summary:

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

Detailed Description:

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.

In practice:

  1. ASAS signs are not systematically found in the West Indies (sacroiliitis, uveitis, cervicitis, urethritis, inflammatory syndrome, HLAB27 ...)
  2. Apart from cases associated with Chronic Inflammatory Bowel Disease (IBD), clinical panels are atypical and the ASAS criteria for little help
  3. 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.


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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Intervention Details:
  • Diagnostic Test: Evaluation of ASAS criteria
    Perform ASAS criteria at the time of physician diagnosis of chronic low back pain in rheumatological practice.


Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient with presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005
Criteria

Inclusion Criteria:

  • Patient over 18 years of age
  • Patient seen in the usual framework of the consultation of rheumatology
  • Patients consulting with:
  • Presence or history of chronic low back pain (≥ 3 months) that started before the age of 45 with an onset of low back pain after 2005:
  • Or with known sacroiliitis or asymmetric inflammatory rheumatism
  • Or with chronic inflammatory bowel disease (Crohn, ulcerative colitis (RCH) ...) and associated inflammatory rheumatism
  • Patients who received a lumbosacral MRI after 2005
  • Patient not participating in a clinical trial

Exclusion criteria:

  • Patient under 18 years of age
  • Patient participating in another clinical trial

Information from the National Library of Medicine

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


Contacts
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Contact: Michel MD De Bandt, PHD 0596 55 23 31 ext +596 micheldebandt@gmail.com
Contact: Marie MB Blettery, MD 0596 55 23 31 ext +596 marie.blettery@chu-martinique.fr

Locations
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Martinique
CHU de Martinique Recruiting
Fort-de-France, Martinique, 97261
Contact: Véronique Mr ERDUAL    0596592696 ext +596    veronique.erdual@chu-martinique.com   
Principal Investigator: Michel Mr De Bandt, PHD         
Sponsors and Collaborators
University Hospital Center of Martinique
Investigators
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Principal Investigator: Michel MD De Bandt CHU de Martinique

Publications:

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Responsible Party: University Hospital Center of Martinique
ClinicalTrials.gov Identifier: NCT03564743     History of Changes
Other Study ID Numbers: 14/E/20
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital Center of Martinique:
Spondyloarthritis
ASAS criteria
Diagnosis criteria
Classification criteria
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases