NCT05862584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
9 days until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 23, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2024

Completed
Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

8 months

First QC Date

April 24, 2023

Last Update Submit

May 21, 2026

Conditions

Outcome Measures

Primary Outcomes (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).

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

    Every week for 6 months

Secondary Outcomes (2)

  • 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 Arms (1)

Main Cohort

EXPERIMENTAL

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

Interventions

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

Main Cohort

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patient with no fixed abode
  • Patient planning to move within 6 months.
  • Patient unable to read or understand the non-opposition notice.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nice University Hospital

Nice, 06200, France

Location

MeSH Terms

Conditions

Arthritis, RheumatoidSpondylitis, AnkylosingArthritis, Psoriatic

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesAxial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesAnkylosisPsoriasisSkin Diseases, PapulosquamousSkin Diseases

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 24, 2023

First Posted

May 17, 2023

Study Start

May 26, 2023

Primary Completion

January 23, 2024

Study Completion

June 23, 2024

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations