National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis
NCT ID: NCT06876064
Last Updated: 2025-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
150 participants
OBSERVATIONAL
2025-10-31
2027-12-31
Brief Summary
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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.
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Detailed Description
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Four groups of adults will be included:
* Group 1: 50 subjects at very high risk of RA: ACPA≥2 N or (ACPA\>N and rheumatoid factor≥2 N) + presence of clinically suspicious arthralgia (CSA criteria ≥4)
* Group 2: 50 subjects at high risk of RA: ACPA≥2 N or (ACPA\>N and rheumatoid factor≥2 N) without clinically suspicious arthralgia (CSA criteria \<4)
* Group 3: 25 asymptomatic subjects, 1st degree relatives of subjects with RA (negative controls)
* Group 4: 25 patients with early RA prior to any disease-modifying therapy (positive controls) Patients in the control groups will be included based on the same age and sex as patients in the risk groups (1 \& 2) in the recruiting center.
The primary endpoint is the occurrence of clinical arthritis, confirmed by ultrasound, after two years of follow-up in the at-risk RA groups (Groups 1 \& 2).
This may be explained by the following exposures or their combinations: smoking, occupational exposure, physical activity, diet, hormonal exposure, drug exposure, trauma and psychological stress...
Other factors that may contribute to the occurrence of clinical arthritis include:
* Clinical elements and questionnaires assessing the other symptoms of the individuals (PRO) (subjective clinical suspicion of arthralgia CSA, painful joints at inclusion, BMI, stool consistency, functional respiratory signs, etc.)
* Comorbidities and antecedents via CNAM pathology mapping and drug exposure via data on dispensing in towns from the SNDS
* Current biology: ACPA levels, rheumatoid factor levels and isotypes, CRP levels at baseline, etc.
* Ultrasound and MRI abnormalities.
The controls groups (groups 3\&4) will allow for a cross-sectional analysis, comparing at-risk RA subjects with healthy individuals who share the same genetic background. They will have a single visit at baseline without follow-up.
However, the at-risk RA groups (groups 1 \& 2) will have four visits (M0, M6, M12 et M24). In addition to routine care examinations performed in RA risk situations, subjects will undergo blood and stool sample collection at baseline and at one year.
All subjects regardless of group, will undergo the following baseline assessments: MRI of the dominant hand or painful hand, a lactulose absorption test (to assess intestinal permeability), hair and saliva collection, a Schirmer test, and, in some centers, an induced sputum test (to assess pulmonary mucosa). Ultrasound of the hands and feet, as well as specific questionnaires assessing the exposome, will be conducted at all visits.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group 1
A total of 50 subjects will be recruited: individuals with ACPA≥2 N and clinically suspect arthralgia (CSA criteria ≥4) or those with ACPA≥N and rheumatoid factor≥2N along with clinically suspect arthralgia (CSA criteria ≥4). These subjects have an estimated 50% risk of progression to RA within 2 years.
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.
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).
Group 2
A total of 50 subjects will be recruited: individuals with ACPA≥2 N who do not meet the criteria for clinically suspect arthralgia (CSA criteria \<4) or those with ACPA≥N and rheumatoid factor≥2N who also do not meet the criteria for clinically suspect arthralgia (CSA criteria \<4). These subjects have an estimated 30% risk of progression to RA within 2 years.
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.
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).
Group 3
A total 25 subjects will be recruited: asymptomatic subjects (CSA criteria \<4) with a family history of RA in a first-degree relative (negative controls).
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.
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.
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).
Group 4
A total of 25 subjects will be recruited: individuals with RA diagnosed at polyarthritis onset (diagnosis \<6 months) who have not yet been treated, with ACPA≥2 N or ACPA≥N and rheumatoid factor≥2N (positive controls).
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.
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).
Interventions
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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.
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).
Eligibility Criteria
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Inclusion Criteria
* 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
• 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
18 Years
80 Years
ALL
Yes
Sponsors
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Nantes University Hospital
OTHER
Assistance Publique Hopitaux De Marseille
OTHER
UNIVERSITY HOSPITAL, ORLEANS
UNKNOWN
Bicetre Hospital
OTHER
Saint Antoine University Hospital
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
University Hospital, Brest
OTHER
Assistance Publique - Hôpitaux de Paris
OTHER
University Hospital, Bordeaux
OTHER
Hôpital Cochin
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Locations
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CHU Montpellier
Montpellier, Hérault, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Eudra CT/ID-RCB
Identifier Type: OTHER
Identifier Source: secondary_id
RECHMPL24_0015
Identifier Type: -
Identifier Source: org_study_id
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