NCT06876064 National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

Eligibility & Interventions

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What to Expect as a Participant

This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.

This trial targets 150 participants in total. It began in 2025-10-07 with a primary completion date of 2029-12.

Brief 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 Criteria

Inclusion Criteria: * 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). Exclusion Criteria: * Groupe1-2-3: • Presence of clinical joint swelling (synovitis) at the time of inclusion and previously noted by a doctor * All groups: * Taking current or past background treatment for RA, even for another indication * Corticosteroid therapy ≥10 mg at baseline and in the previous week * Presence of another connective tissue disease (Sjögren's, dermatomyositis, scleroderma, Sharp syndrome, etc.) * Subject unable to read and/or write * Inability to follow the patient during the study period * Failure to obtain consent * Non-affiliation to a social security scheme, * Persons placed under legal protection, under curatorship or under guardianship * Pregnant or breastfeeding women * Person participating in another intervention research including an * exclusion period still in progress

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