Impact of Air Pollution on the Course of Inflammatory Rheumatism

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05862584
Collaborator
(none)
400
1
1
14
28.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Questionnaires
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
400 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Impact of Air Pollution on the Course of Inflammatory Rheumatism: a Prospective, Single-center Study
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Jul 30, 2024
Anticipated Study Completion Date :
Jul 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Main Cohort

Cohort of patients with inflammatory rheumatism (rheumatoid arthritis or spondyloarthritis diagnosed according to ACR/EULAR 2010 or ASAS), over 18 years of age, and with stable chronic inflammatory rheumatism under biological treatment

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

Outcome Measures

Primary Outcome Measures

  1. 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). [Every week for 6 months]

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

Secondary Outcome Measures

  1. Relationship between average exposure to regulated pollutants and severity of SPA/PR. [Every week for 6 months]

    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.

  2. Correlations between average exposure to regulated pollutants and biological severity of SPA/PR. [Every week for 6 months]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nice University Hospital Nice France 06200

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05862584
Other Study ID Numbers:
  • 23-PP-02
First Posted:
May 17, 2023
Last Update Posted:
May 17, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2023