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National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

Study acronym: PROMESS_1
StatusRecruiting
PhaseNot specified
Started2025-10-07
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 23 months later Dec 2027 → Dec 2029
See other at-risk trials from University Hospital, Montpellier

Amendment history

2026-10-02
Recruitment opened
Primary completion pushed: 2027-12 → 2029-12
Completion pushed: 2027-12 → 2029-12
Interventions modified
2025-09-25
Study Status, Oversight, Arms and Interventions, Outcome Measures v1
Primary completion date2027-08→2027-12
Completion date2027-08→2027-12
Start date2025-04→2025-10
InterventionsBlood test (Biological), Hair sampling (Other), Induced expectoration (Other), MRI Contrast (Radiation), Patient questions (Other)…→Blood test (Biological), Consultation with a psychologist in certain centers (Other), Dental panoramic X-ray (Diagnostic Test), Hair and…
Secondary endpoints59 to 61 entries
Analyzing heart rate variability as a risk factor for developing RA Analyze environmental factors associated with the risk of developing clinical arthritis.
2025-03-07
Original filing
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.
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, Université Paris Cité, Hôpital Européen Marseille, University of Montpellier - Inserm 1046 - PhyMeddExp, Aix Marseille Université
Conditions Rheumatoid Arthritis (RA)
Enrollment 150 participants
Start Date 2025-10-07
Primary Completion 2029-12 (estimated)
Study Completion 2029-12 (estimated)
Updated on ClinicalTrials.gov 2026-10-01