At-risk rheumatoid arthritis cohort to see if exposures predict early arthritis
Official title: National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis
Run by University Hospital, Montpellier · NCT06876064 · Data updated 2026-11-12
This study follows people at high risk for rheumatoid arthritis to see if factors like smoking, diet, or stress can predict the development of arthritis over two years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Locations | 1 site (Montpellier, Hérault) |
| Status | Recruiting |
| Started | October 7, 2025 |
| Main results expected | December 2029 |
| Study ends | December 2029 |
| Registry record updated | October 1, 2026 |
| Trial ID | NCT06876064 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–80 who fall into one of four groups: very high-risk with arthralgia, high-risk without arthralgia, first-degree relatives without symptoms, or newly diagnosed untreated RA patients (controls).
✕Probably not a fit
Individuals who do not develop clinical arthritis within two years or who do not have the specified risk profiles may receive no direct benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter observational cohort study enrolls adults at varying risk levels for RA to identify factors associated with progression to clinical arthritis confirmed by ultrasound over two years. Participants are grouped as very high risk, high risk, asymptomatic first-degree relatives, and untreated early RA controls, with data collected on exposures, symptoms, biology, and imaging. The study analyzes how combinations of exposures—such as smoking, occupational factors, physical activity, hormones, medications, trauma, and psychological stress—relate to arthritis onset, alongside baseline ACPA, rheumatoid factor, CRP, ultrasound, and MRI findings. Interventions are limited to non-pharmacologic samples and tests (blood, urine, stool, saliva) rather than disease treatment. The primary endpoint is ultrasound-confirmed clinical arthritis at two years in the at-risk groups.
Why it matters
Potential benefit: If successful, the study could improve understanding of who will develop RA, potentially guiding earlier monitoring or preventive strategies.
How similar studies have gone: Prior approaches using biomarkers and imaging have shown promise in predicting RA risk, but this specific risk-exposure cohort approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
CHU Montpellier
Montpellier, Hérault, France Recruiting
Study contacts
- Study coordinator: Claire Immediato Daien, Professor
- Email: c-daien@chu-montpellier.fr
- Phone: 00 33 6 85 40 27 87
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.