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Impact of Air Pollution on the Course of Inflammatory Rheumatism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05862584
Recruitment Status : Active, not recruiting
First Posted : May 17, 2023
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nice

Study Description
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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
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis Other: Questionnaires Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 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
Actual Study Start Date : May 26, 2023
Estimated Primary Completion Date : July 30, 2024
Estimated Study Completion Date : July 30, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Air Pollution

Arms and Interventions
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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
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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). [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 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
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05862584


Locations
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France
Nice University Hospital
Nice, France, 06200
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT05862584    
Other Study ID Numbers: 23-PP-02
First Posted: May 17, 2023    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Rheumatic Fever
Arthritis
Arthritis, Psoriatic
Spondylitis, Ankylosing
Rheumatic Diseases
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases
Spondylarthropathies
Spondylarthritis
Spinal Diseases
 Bone Diseases
Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Bone Diseases, Infectious
Infections
Axial Spondyloarthritis
Ankylosis
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses