Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment (SPAIR)

October 5, 2023 updated by: Centre Hospitalier Universitaire de Besancon

The relationship between exposure to air pollution and spondyloarthritis (SpA) has been poorly studied. Based on data from the literature on other inflammatory pathologies such as rheumatoid arthritis, we hypothesize that there is a relationship between exposure to air pollution and the risk of presenting a flare-up in SpA patients following and living in Franche-Comté (France).

Primary objective:The potential relationship between exposure to air pollution (nitrogen dioxide, fine particles with a diameter of less than 10 or 2.5 microns and Ozone) and the onset of a spondyloarthritis flare-up will be explored in patients with this pathology.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

175

Contacts and Locations

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

Study Contact

Study Locations

  • France
    • Bourgogne Franche Comté
      • Besançon, Bourgogne Franche Comté, France, 25000
        • Besançon University Hospital
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of Axial Spondyloarthritis, received in rheumatology consultation/hospitalization over the period 2019-2022 and living in Franche-Comté over the same period.

Description

Inclusion Criteria:

  • Diagnosis of Axial Spondyloarthritis (radiographic or non-radiographic) according to Assessment of SpondyloArthritis international Society (ASAS) criteria
  • Patient having received a consultation / hospitalization during the period 2019-2022
  • Patient enrolled in the MISTIC cohort
  • Having lived in Franche-Comté during the 2019-2022 period.

Exclusion Criteria:

  • Other chronic inflammatory rheumatism (rheumatoid arthritis according to ACR 2010 criteria or psoriatic arthritis according to ClASsification criteria for Psoriatic ARthritis criteria)
  • No inflammatory rheumatic disease

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with a diagnosis of Axial Spondyloarthritis
Patients with a diagnosis of Axial Spondyloarthritis, received in rheumatology consultation/hospitalization over the period 2019-2022 and living in Franche-Comté over the same period
Other: Assessment of exposure to air pollution
For each patient, exposure to air pollution will be assessed over a period immediately prior to any flare-up and over four periods at a distance from the flare-up.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of a SpA flare-up
Time Frame: 6 to 24 months
The occurrence of a SpA flare-up measured by disease activity, defined according to the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) and/or ASDAS-CRP (Ankylosing Spondylitis Disease Activity Score - C reactive protein) scores (BASDAI score ≥4/10 and/or ASDAS-CRP score ≥2.1) according to ASAS group
6 to 24 months

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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 (Estimated)

October 15, 2023

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

October 15, 2025

Study Registration Dates

First Submitted

October 5, 2023

First Submitted That Met QC Criteria

October 5, 2023

First Posted (Actual)

October 11, 2023

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 5, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023/811

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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