Status:
NOT_YET_RECRUITING
National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis
Lead Sponsor:
University Hospital, Montpellier
Collaborating Sponsors:
Nantes University Hospital
Assistance Publique Hopitaux De Marseille
Conditions:
Rheumatoid Arthritis (RA)
Eligibility:
All Genders
18-80 years
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 patient...
Detailed Description
This is a multicenter interventional cohort study. The goal of this cohort is to analyze the factors associated with the risk of developing clinical arthritis, considering individual or combined expos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06876064
Start Date
October 1 2025
End Date
December 1 2027
Last Update
October 1 2025
Active Locations (1)
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1
CHU Montpellier
Montpellier, Hérault, France, 34000