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

Sponsor

Centre Hospitalier Universitaire de Besancon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06077604

Collaborator

(none)

175

Enrollment

Location

Anticipated Duration (Months)

7.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Spondyloarthritis, Axial	Other: Assessment of exposure to air pollution

Study Design

Study Type:

Observational

Anticipated Enrollment :

175 participants

Observational Model:

Case-Crossover

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Oct 15, 2023

Anticipated Primary Completion Date :

Oct 15, 2025

Anticipated Study Completion Date :

Oct 15, 2025

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Occurrence of a SpA flare-up [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Besançon University Hospital	Besançon	Bourgogne Franche Comté	France	25000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Besancon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Besancon

ClinicalTrials.gov Identifier:

NCT06077604

Other Study ID Numbers:

2023/811

First Posted:

Oct 11, 2023

Last Update Posted:

Oct 11, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Besancon

Air pollution

Additional relevant MeSH terms:

Spondylitis

Spondylarthritis

Axial Spondyloarthritis

Study Results

No Results Posted as of Oct 11, 2023