Impact of Air Pollution on the Course of Inflammatory Rheumatism

Rheumatoid Arthritis Clinical Trial

Official title:

Impact of Air Pollution on the Course of Inflammatory Rheumatism: a Prospective, Single-center Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05862584
• Other study ID #: 23-PP-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 26, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to see if there is a link between air pollution and inflammatory rheumatism (rheumatoid arthritis and ankylosing spondylitis)

To do this, the investigators are going to follow a cohort of about 200-400 patients for 6 months by means of a self-questionnaire, which the investigators ask the patient to fill in once a week on a fixed day, and opposite the corresponding week to put the letter corresponding to the question concerning the activity of your disease: 3 possible answers: A: no flare-up, B: short flare-up of 1 to 3 days, C: persistent flare-up of more than 3 days

Then the investigators will collect the questionnaire at the end of these 6 months and at each visit to the consultation or day hospital (on average every 4 to 6 weeks), and they will look to see if any relapses have occurred. At the same time the investigators will calculate the disease activity score (DAS or BASDAI) to have an objective score. Then in parallel they will look at the level of exposure to air pollution according to the place of residence and work of each patient.

The hypothesis is that air pollution has an influence on the activity of inflammatory rheumatism.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 86
• Est. completion date: July 30, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with RA according to ACR/EULAR 2010 criteria, or spondyloarthritis according to ASAS criteria.

• Patients older than 18 years of age

• Patients with RA or spondyloarthritis considered stable (no change in background or biological therapy for at least 3 months) and in low activity (SAR 28 CRP < 3.2 for RA and BASDAI < 4 for 3 months).

• Patient treated with biological therapy

Exclusion Criteria:

• Patient with no fixed abode

• Patient planning to move within 6 months.

• Patient unable to read or understand the non-opposition notice.

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis
• Arthritis, Psoriatic
• Psoriatic Arthritis
• Rheumatic Diseases
• Rheumatic Fever
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing

Intervention

Other:
• Questionnaires
Distribution of questionnaires to patients to be completed on a weekly basis.

Locations

Country	Name	City	State
France	Nice University Hospital	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Show that there is a difference in average exposure to regulated pollutants according to the occurrence or non-occurrence of inflammatory rheumatism (RA or APS).	Occurrence of a flare-up of less than 3 days and/or more than 3 days	Every week for 6 months
Secondary	Relationship between average exposure to regulated pollutants and severity of SPA/PR.	The relationship between average exposure to regulated pollutants and severity (duration of flare) of SPA/PR data of flare-up of less than 3 days and/or more than 3 days will be collected with questionnaires.	Every week for 6 months
Secondary	Correlations between average exposure to regulated pollutants and biological severity of SPA/PR.	Correlations between average exposure to regulated polluants and biological severity data of flare-up of less than 3 days and/or more than 3 days will be collected with questionnaires.	Every week for 6 months