search
Back to results

Impact of Air Pollution on the Course of Inflammatory Rheumatism

Primary Purpose

Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaires
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nice University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Main Cohort

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
April 24, 2023
Last Updated
May 15, 2023
Sponsor
Centre Hospitalier Universitaire de Nice
search

1. Study Identification

Unique Protocol Identification Number
NCT05862584
Brief Title
Impact of Air Pollution on the Course of Inflammatory Rheumatism
Official Title
Impact of Air Pollution on the Course of Inflammatory Rheumatism: a Prospective, Single-center Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Main Cohort
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
Distribution of questionnaires to patients to be completed on a weekly basis.
Primary Outcome Measure Information:
Title
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).
Description
Occurrence of a flare-up of less than 3 days and/or more than 3 days
Time Frame
Every week for 6 months
Secondary Outcome Measure Information:
Title
Relationship between average exposure to regulated pollutants and severity of SPA/PR.
Description
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.
Time Frame
Every week for 6 months
Title
Correlations between average exposure to regulated pollutants and biological severity of SPA/PR.
Description
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.
Time Frame
Every week for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ROUX Christian
Phone
0492035491
Email
roux.c2@chu-nice.fr
Facility Information:
Facility Name
Nice University Hospital
City
Nice
ZIP/Postal Code
06200
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROUX Christian
Phone
0492035491
Email
roux.c2@chu-nice.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Impact of Air Pollution on the Course of Inflammatory Rheumatism

We'll reach out to this number within 24 hrs