National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

Condition(s) studied

Investigational drug(s) / intervention(s)

Blood test: A total of 90 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.

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

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

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

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

Hair and nails sampling: Hair and nails samples will be collected.

Schirmer test: To assess of tear secretion

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

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

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.

Dental panoramic X-ray: Performed as part of routine care to assess dental health

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

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).

Behavioral: semi-structured psychological interview (1 h, teleconsultation): At W0 on V1 an affective touch perception test (15 min), self-assessment of perceived RA risk, satisfaction and impact questionnaire. at week 26, optionally completed by an in-person session (self-drawing, Rorschach test, Thematic Apperception Test; 1 h)

Study 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.

Eligibility

Primary outcome measure(s)

• Risk of developing clinical arthritis — From the baseline to the end of the follow-up at 2 years
  To analyze the factors associated with the risk of developing clinical arthritis confirmed by ultrasound among exposures or combinations of exposures in patients at high risk of RA.

Trial sites (1)

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