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

July 18, 2023 updated by: University Hospital Center of Martinique

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.

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.

Study Overview

Status

Completed

Conditions

Spondyloarthritis

Intervention / Treatment

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:

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

Enrollment (Actual)

104

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Martinique
- - Fort-de-France, Martinique, 97261
    - CHU de Martinique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	September 2018
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).	September 2018

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	September 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Center of Martinique

Investigators

Principal Investigator: Michel MD De Bandt, CHU de Martinique

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2015

Primary Completion (Actual)

November 1, 2020

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

April 19, 2017

First Submitted That Met QC Criteria

June 19, 2018

First Posted (Actual)

June 21, 2018

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 18, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

14/E/20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.