National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

Not yet recruitingOBSERVATIONAL
Enrollment

150

Participants

Timeline

Start Date

October 31, 2025

Primary Completion Date

December 31, 2027

Study Completion Date

December 31, 2027

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).

Trial Locations (1)

34000

CHU Montpellier, Montpellier

All Listed Sponsors
collaborator

Nantes University Hospital

OTHER

collaborator

Assistance Publique Hopitaux De Marseille

OTHER

collaborator

UNIVERSITY HOSPITAL, ORLEANS

UNKNOWN

collaborator

Bicetre Hospital

OTHER

collaborator

Saint Antoine University Hospital

OTHER

collaborator

Groupe Hospitalier Pitie-Salpetriere

OTHER

collaborator

University Hospital, Brest

OTHER

collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

collaborator

University Hospital, Bordeaux

OTHER

collaborator

Hôpital Cochin

OTHER

lead

University Hospital, Montpellier

OTHER

NCT06876064 - National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis | Biotech Hunter | Biotech Hunter