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Clinical Trials/NCT05862584
NCT05862584
Active, not recruiting
Not Applicable

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

Centre Hospitalier Universitaire de Nice1 site in 1 country86 target enrollmentMay 26, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rheumatoid Arthritis
Sponsor
Centre Hospitalier Universitaire de Nice
Enrollment
86
Locations
1
Primary Endpoint
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).
Status
Active, not recruiting
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
May 26, 2023
End Date
December 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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).

Time Frame: Every week for 6 months

Occurrence of a flare-up of less than 3 days and/or more than 3 days

Secondary Outcomes

  • Relationship between average exposure to regulated pollutants and severity of SPA/PR.(Every week for 6 months)
  • Correlations between average exposure to regulated pollutants and biological severity of SPA/PR.(Every week for 6 months)

Study Sites (1)

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