Spondyloarthritis, AxialSPAIRNCT06077604
Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment
An observational study of Spondyloarthritis, Axial, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spondyloarthritis, Axial
- What is being tested?
- Assessment of exposure to air pollution
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2024to 15 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Besançon University Hospital
Besançon, Bourgogne-Franche-Comté, 25000
About this study
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.
- Conditions
- Spondyloarthritis, Axial
- Being tested
- Assessment of exposure to air pollution
- Keywords
- Air pollution
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of exposure to air pollutionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Assessment of exposure to air pollution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2023
- Study start1 Mar 2024
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spondyloarthritis, AxialStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06077604
- Sponsor's protocol ID
- 2023/811
- Acronym
- SPAIR
- Status last verified
- Jul 2025
- First submitted
- 5 Oct 2023
- Last updated
- 9 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Air Pollution on SPondyloarthritis Flare-ups and Resistance to Treatment
- ClinicalTrials.gov ID
- NCT06077604
- Acronym / sponsor ID
- SPAIR / 2023/811
- Conditions
- Spondyloarthritis, Axial
- Keywords
- Air pollution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 11 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a diagnosis of Axial Spondyloarthritis | – | Other: Assessment of exposure to air pollutionPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Assessment of exposure to air pollutionFor 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. | Other | Patients with a diagnosis of Axial Spondyloarthritis |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2025.
- Individual participant dataSharing planned: No
Related trials for Spondyloarthritis, Axial
Active, not recruiting
Effects of Resistance Exercise on Enthesitis in Patients With Spondyloarthritis
Spondyloarthritis (SpA), Axial Spondylarthritis (axSpA)
RecruitingPhase 1
A Study of HB0017 Injection in Healthy Volunteers to Evaluate Safety and Tolerability of a Single Subcutaneous Injection in Low-Body-Weight Subjects; and Pharmacokinetics at Different Subcutaneous Injection Sites at the Same Dose
Psoriasis, Ankylosing Spondylitis
RecruitingPhase 1
A Study to Learn if Bimekizumab Given in Different Ways is Safe and Moves Similarly Throughout the Body Over Time in Adults
Psoriatic Arthritis, Axial Spondyloarthritis
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
Identification of Serum Level of Glutathione Peroxidase 4
Spondyloarthropathy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spondyloarthritis, Axial, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of a SpA flare-up (time frame: 6 to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2025.