Impact of Air Pollution on the Course of Inflammatory Rheumatism

NCT ID: NCT05862584

Last Updated: 2024-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-26

Study Completion Date

2024-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Questionnaires

Intervention Type OTHER

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

Interventions

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Questionnaires

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nice University Hospital

Nice, , France

Site Status

Countries

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France

Other Identifiers

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23-PP-02

Identifier Type: -

Identifier Source: org_study_id

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