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

Spondyloarthritis, Axial Clinical Trial

— SPAIR  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06077604
• Other study ID #: 2023/811
• Status: Not yet recruiting
• Start date: October 15, 2023
• Est. completion date: October 15, 2025

Study information

• Verified date: October 2023
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: Sophie Pujol, PhD
• Phone: +33381219049
• Email: spujol[@]chu-besancon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 175
• Est. completion date: October 15, 2025
• Est. primary completion date: October 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis
• Spondylitis
• Spondyloarthritis, Axial

Intervention

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.

Locations

Country	Name	City	State
France	Besançon University Hospital	Besançon	Bourgogne Franche Comté

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of a SpA flare-up	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