Impact of Air Pollution on the Course of Inflammatory Rheumatism

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis
• Intervention / Treatment: Other: Questionnaires

• Study Type: Interventional
• Enrollment (Actual): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ROUX Christian; Phone Number: 0492035491; Email: roux.c2@chu-nice.fr

Study Locations

• France
  • Nice, France, 06200
    • Nice University Hospital
    • Contact: ROUX Christian; Phone Number: 0492035491; Email: roux.c2@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2023
• Primary Completion (Estimated): July 30, 2024
• Study Completion (Estimated): July 30, 2024

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: May 15, 2023
• First Posted (Actual): May 17, 2023

Study Record Updates

• Last Update Posted (Actual): March 18, 2024
• Last Update Submitted That Met QC Criteria: March 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Skin Diseases, Papulosquamous; Spinal Diseases; Bone Diseases; Spondylarthropathies; Spondylarthritis; Psoriasis; Bone Diseases, Infectious; Ankylosis; Axial Spondyloarthritis; Arthritis; Arthritis, Psoriatic; Rheumatic Diseases; Spondylitis; Spondylitis, Ankylosing; Rheumatic Fever
• Other Study ID Numbers: 23-PP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No