National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

ConditionRheumatoid Arthritis (RA)

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-80

SponsorUniversity Hospital, Montpellier

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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

Trial population

The patients will be recruted during consultation or hospitalization.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Blood test
Biological/Vaccine
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
Biological/Vaccine
Urine will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability.
stool collection
Other intervention
Stool samples will be collected either at the hospital or at home using a dedicated kit.
saliva collection
Other intervention
5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit.
Induced expectoration
Other intervention
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
Other intervention
Hair and nails samples will be collected.
Schirmer test
Other intervention
To assess of tear secretion
Ultrasound of hands and feet
Radiation
To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis.
MRI Contrast
Radiation
MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects.
Patient questions
Other intervention
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
Diagnostic test
Performed as part of routine care to assess dental health
Consultation with a psychologist in certain centers
Other intervention
The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist.
Measurement of heart rate variability.
Other intervention
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)
Behavioral
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)

Treatment groups

150 Participants

are divided into 4 treatment groups

Group A: Group 114 interventions

Group B: Group 214 interventions

Group C: Group 312 interventions

Group D: Group 413 interventions

Trial outcomes

Primary outcomes

Risk of developing clinical arthritis

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.

Time frame

From the baseline to the end of the follow-up at 2 years

Secondary outcomes

Quantitative difference in Food Frequency Questionnaire (FFQ) between the 4 groups of subjects included, varying from never or rarely to daily or multiple times per day.

Time frame

At baseline

Quantitative difference in National Observatory for Physical Activity and Sedentariness -Physical Activity Questionnaire (ONAPS-PAQ) expressed in MET (Metabolic Equivalent of Task) per week between the 4 groups of subjects included.

Time frame

At baseline

Quantitative difference in patient-reported exposure outcome Alcohol and Substance Involvement Screening Test (ASSIST) score between the 4 groups of subjects included.

The score varies from 0 to 36 to each substance with higher score indicates greater substance-related risk and the need for stronger intervention strategies.

Time frame

At baseline

Quantitative difference in Fagerström Test for Nicotine Dependence (FTND) score between the 4 groups of subjects included.

The score varies from 1 to 6 with higher score indicate greater nicotine dependence.

Time frame

At baseline

Other outcomes

Association between comorbidities and medical history

(CNAM pathology mapping) and drug exposure (SNDS dispensing data) and the risk of clinical arthritis in Groups 1 and 2." Time frame: SNDS linkage at end of study.

Time frame

From the baseline to the end of the follow-up at 2 years

Association between psychological, psychiatric and psychosomatic factors

(BDI, MAIA, QSSP, TAS-20, Cambridge Depersonalization Scale, DES, psychological pain VAS, RFQ-B, affective touch perception test) and the risk of clinical arthritis in Groups 1 and 2, and comparison between groups.

Time frame

baseline, week 26, week 52 and week 104, depending on the instrument.

Association between blood and pulmonary immunobiological characteristics

(immunophenotyping on fresh blood, induced sputum) and the risk of clinical arthritis in Groups 1 and 2

Time frame

baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Nantes University Hospital

Collaborator

Assistance Publique Hopitaux De Marseille

Collaborator

University of New Orleans

Collaborator

Bicetre Hospital

Collaborator

Saint Antoine University Hospital

Collaborator

Groupe Hospitalier Pitie-Salpetriere

Collaborator

University Hospital, Brest

Collaborator

Assistance Publique - Hôpitaux de Paris

Collaborator

University Hospital, Bordeaux

Collaborator

Hôpital Cochin

Collaborator

Université Paris Cité

Collaborator

Hôpital Européen Marseille

Collaborator

University of Montpellier - Inserm 1046 - PhyMeddExp

Collaborator

Aix Marseille Université

Collaborator

Source ClinicalTrials.gov

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