National Cohort of Subjects At Risk of Developing Rheumatoid Arthritis

Launched by UNIVERSITY HOSPITAL, MONTPELLIER · Mar 7, 2025

Keywords

ClinConnect Summary

The PROMESS 1 trial is a research study looking at people who might be at risk of developing rheumatoid arthritis (RA). Researchers want to understand what factors, like smoking, diet, and stress, could lead to the development of arthritis in individuals who have high levels of certain antibodies in their blood. The main goal of the study is to see if participants develop clinical arthritis over a two-year period, using ultrasound to confirm any findings.

To be eligible for this study, participants should be between 18 and 80 years old. There are different groups: one group consists of people with high antibody levels and joint pain, another group has high antibody levels but no pain, a third includes relatives of RA patients, and the fourth group includes newly diagnosed RA patients. Participants will be closely monitored over the study period, and they need to meet certain criteria to join, such as not having any current joint swelling or other autoimmune diseases. This trial is not yet recruiting, but once it starts, it will provide important insights into the risk factors for developing RA.

Gender

ALL

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