National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

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.

Conditions

• Rheumatoid Arthritis (RA)

Interventions

BIOLOGICAL

Blood test

A total of 60 ml of blood will be collected while fasting, using the following tubes: one PAXGene Blood RNA Tube, one PAXGene Blood DNA Tube, five 5 mL serum tubes, five 5 mL EDTA tubes and one 2 mL EDTA tube for microbiota DNA analysis.

BIOLOGICAL

Urine test

Urine will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability.

OTHER

stool collection

Stool samples will be collected either at the hospital or at home using a dedicated kit.

OTHER

saliva collection

5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit.

OTHER

Induced expectoration

inhalation of salbutamol, measurement of peak expiratory flow by screening spirometry (15 min later), inhalation of a hypertonic aerosol for 3 periods of 7 min. At the end of each inhalation period, the induced sputum is collected and the peak expiratory flow is measured to prevent possible bronchospasms

OTHER

Hair and nails sampling

Hair and nails samples will be collected.

OTHER

Schirmer test

To assess of tear secretion

RADIATION

Ultrasound of hands and feet

To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis.

RADIATION

MRI Contrast

MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects.

OTHER

Patient questions

Self-questionnaires will assess factors such as ethnic origin, family history of RA, diet, physical activity, exposure to toxic substances, pollution, occupational exposures, psychological and clinical factors.

DIAGNOSTIC_TEST

Dental panoramic X-ray

Performed as part of routine care to assess dental health

OTHER

Consultation with a psychologist in certain centers

The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist.

OTHER

Measurement of heart rate variability.

The patient will wear a belt throughout the visit 1. At the end of the day, the heart rate variability data measured by the belt will be recorded in the CRF (RR interval, heart rate variability SDNN, RMSSD, and LF/HF sympathovagal balance).

Sponsors & Collaborators

• Nantes University Hospital

  collaborator OTHER

• Assistance Publique Hopitaux De Marseille

  collaborator OTHER

• UNIVERSITY HOSPITAL, ORLEANS

  collaborator UNKNOWN

• Bicetre Hospital

  collaborator OTHER

• Saint Antoine University Hospital

  collaborator OTHER

• Groupe Hospitalier Pitie-Salpetriere

  collaborator OTHER

• University Hospital, Brest

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  collaborator OTHER

• University Hospital, Bordeaux

  collaborator OTHER

• Hôpital Cochin

  collaborator OTHER

• University Hospital, Montpellier

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-10-31

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• France

Study Locations