Clinical Trial

National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

Study acronym: PROMESS_1
Not Yet Recruiting
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-03-07.
Trial Details
NCT Number NCT06876064
Lead Sponsor University Hospital, Montpellier
Collaborators: Nantes University Hospital, Assistance Publique Hopitaux De Marseille, University of New Orleans, Bicetre Hospital, Saint Antoine University Hospital, Groupe Hospitalier Pitie-Salpetriere, University Hospital, Brest, Assistance Publique - Hôpitaux de Paris, University Hospital, Bordeaux, Hôpital Cochin
Conditions Rheumatoid Arthritis (RA)
Enrollment 150 participants
Start Date 2025-10
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2025-10-01