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National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

Status: Recruiting
Location: See location...
Intervention Type: Other, Radiation, Biological, Behavioral, Diagnostic test
Study Type: Observational
SUMMARY

PROMESS 1 is a multicenter cohort interventional study aiming at analyzing the factors associated with the risk of developing clinical arthritis among exposures or combinations of exposures in patients at risk of rheumatoid arthritis (RA), as they have high levels of anti-citrullinated peptides autoantibodies (ACPA ≥2 N). The primary endpoint is the occurrence of clinical arthritis confirmed by ultrasound at two years of following for the subject's groups at risk of RA. This may be explained by the following exposures or combinations of exposures: smoking, occupational exposure, physical activity, diet, hormonal exposure, drug exposure, trauma and psychological stress. Other factors may also explain the occurrence of clinical arthritis: * Other symptoms * Comorbidities, medical history, drug exposures * Current biology: ACPA levels, rheumatoid factor levels and isotypes, CRP levels at baseline, etc. * Ultrasound and MRI abnormalities.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• Age between 18 and 80 years old

• Group 1: Individuals with high risk of RA (ACPA ≥ 2N or ACPA ≥ N and rheumatoid factor ≥ 2N) and clinical signs of arthralgia (CSA criteria ≥ 4).

• Group 2: High-risk individuals (ACPA ≥ 2N or ACPA ≥ N and rheumatoid factor ≥ 2N) without clinical arthralgia (CSA criteria \< 4).

• Group 3: First-degree relatives of RA patients (no symptoms, negative controls).

• Group 4: Newly diagnosed untreated RA patients (ACPA ≥ 2N or ACPA ≥ N and rheumatoid factor ≥ 2N) (positive controls).

Locations
Other Locations
France
CHU Montpellier
RECRUITING
Montpellier
Contact Information
Primary
CLAIRE IMMEDIATO DAIEN, PROFESSOR
c-daien@chu-montpellier.fr
00 33 6 85 40 27 87
Time Frame
Start Date: 2025-10-07
Estimated Completion Date: 2029-12
Participants
Target number of participants: 150
Treatments
Group 1
A total of 50 subjects will be recruited: individuals with ACPA≥2 N and clinically suspect arthralgia (CSA criteria ≥4) or those with ACPA≥N and rheumatoid factor≥2N along with clinically suspect arthralgia (CSA criteria ≥4). These subjects have an estimated 50% risk of progression to RA within 2 years.
Group 2
A total of 50 subjects will be recruited: individuals with ACPA≥2 N who do not meet the criteria for clinically suspect arthralgia (CSA criteria \<4) or those with ACPA≥N and rheumatoid factor≥2N who also do not meet the criteria for clinically suspect arthralgia (CSA criteria \<4). These subjects have an estimated 30% risk of progression to RA within 2 years.
Group 3
A total 25 subjects will be recruited: asymptomatic subjects (CSA criteria \<4) with a family history of RA in a first-degree relative (negative controls).
Group 4
A total of 25 subjects will be recruited: individuals with RA diagnosed at polyarthritis onset (diagnosis \<6 months) who have not yet been treated, with ACPA≥2 N or ACPA≥N and rheumatoid factor≥2N (positive controls).
Sponsors
Collaborators: Hôpital Cochin, Assistance Publique Hopitaux De Marseille, Hôpital Européen Marseille, Bicetre Hospital, Nantes University Hospital, Saint Antoine University Hospital, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Brest, University of Montpellier - Inserm 1046 - PhyMeddExp, Assistance Publique - Hôpitaux de Paris, Université Paris Cité, University Hospital, Bordeaux, University of New Orleans, Aix Marseille Université
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov