National Cohort of Subjects At Risk of Developing Rheumatoid Arthritis

Not yet recruiting

• Conditions: Rheumatoid Arthritis (RA)
• Interventions: Biological: Blood test; Biological: Urine test; Other: stool collection; Other: saliva collection; Other: Induced expectoration; Other: Hair sampling; Other: Schirmer test; Radiation: Ultrasound of hands and feet; Radiation: MRI Contrast; Other: Patient questions

• Registration Number: NCT06876064
• Lead Sponsor: University Hospital, Montpellier

Brief 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.

Detailed Description

This is a multicenter interventional cohort study. The goal of this cohort is to analyze the factors associated with the risk of developing clinical arthritis, considering individual or combined exposures, in patients at high risk of rheumatoid arthritis (RA).

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.

Study Timeline

• Study First Submitted: 2024-12-24
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-07
• Last Update Submitted: 2025-03-07
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14
• Study Start: 2025-04
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 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).
• Group 4: Newly diagnosed untreated RA patients (ACPA ≥ 2N or ACPA ≥ N and rheumatoid factor ≥ 2N) (positive controls).

Exclusion Criteria

• Groupe1-2-3:

  • 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Blood test	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.
Group 1	Urine test	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.
Group 1	stool collection	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.
Group 1	saliva collection	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.
Group 1	Induced expectoration	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.
Group 1	Hair sampling	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.
Group 1	Schirmer test	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.
Group 1	Ultrasound of hands and feet	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.
Group 1	MRI Contrast	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.
Group 1	Patient questions	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.
Group 2	Blood test	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.
Group 2	Urine test	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.
Group 2	stool collection	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.
Group 2	saliva collection	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.
Group 2	Induced expectoration	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.
Group 2	Hair sampling	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.
Group 2	Schirmer test	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.
Group 2	Ultrasound of hands and feet	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.
Group 2	MRI Contrast	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.
Group 2	Patient questions	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.
Group 3	Blood test	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).
Group 3	Urine test	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).
Group 3	stool collection	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).
Group 3	saliva collection	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).
Group 3	Induced expectoration	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).
Group 3	Hair sampling	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).
Group 3	Schirmer test	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).
Group 3	Ultrasound of hands and feet	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).
Group 3	MRI Contrast	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).
Group 3	Patient questions	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).
Group 4	Blood test	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).
Group 4	Urine test	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).
Group 4	stool collection	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).
Group 4	saliva collection	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).
Group 4	Induced expectoration	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).
Group 4	Hair sampling	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).
Group 4	Schirmer test	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).
Group 4	Ultrasound of hands and feet	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).
Group 4	MRI Contrast	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).
Group 4	Patient questions	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).

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Quantitative difference in Fagerström Test for Nicotine Dependence (FTND) score between the 4 groups of subjects included.	At baseline	The score varies from 1 to 6 with higher score indicate greater nicotine dependence.
Quantitative difference in patient-reported Francis score for Irritable Bowel Syndrome (IBS) between the 4 groups of subjects included.	At baseline	The score varies from 0 to 100 with higher score means severe IBS.
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.	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.	At baseline
Compare the exposure to pollution between the 4 groups of subjects included. "Exposure to pollution will be assessed by cross-referencing residential addresses with the Chimère database.	At baseline
Qualitative difference in a self-report integrated questionnaire for diagnosis of all functional gastrointestinal disorders in adults between the 4 groups of subjects included.	At baseline
Quantitative difference in patient-reported exposure outcome Alcohol and Substance Involvement Screening Test (ASSIST) score between the 4 groups of subjects included.	At baseline	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.
Qualitative difference in patient-reported clinical outcome of Sleep Apnea (Berlin questionnaire) between the 4 groups of subjects included.	At baseline	It is composed of 3 categories of questions, if 2 or more categories are positive it means a high risk of apnea.
Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the 4 groups of subjects included.	At baseline	The score varies from 0 to 100 with higher score means worst pain possible.
Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the 4 groups of subjects included.	At baseline	The score varies from 0 to 100 with higher score means extreme fatigue.
Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the 4 groups of subjects included.	At baseline	The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity).
Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the 4 groups of subjects included.	At baseline	The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity).
Quantitative difference in Pichot Fatigue Scale score between the 4 groups of subjects included.	At baseline	The score varies from 0 to 32 with higher score means severe fatigue.
Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the 4 groups of subjects included.	At baseline	The score varies from 20 to 80 with higher score means high anxiety.
Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the 4 groups of subjects included,	At baseline	The score varies from 0 to 80 with higher score means very severe symptoms (Likely posttraumatic stress disorder (PTSD)).
Quantitative difference in patient-reported outcome heath survey Short Form-12 (SF-12) version 2 with Physical Component Summary (PCS) and Mental Component Summary (MCS) scores between the 4 groups of subjects included	At baseline	The mean is 50 for each score with a standard deviation of 10, a higher score means better health status.
Quantitative difference in Insomnia Severity Index (ISI) score between the 4 groups of subjects included	At baseline	The score varies from 0 to 28 with higher score means Severe insomnia.
Quantitative difference in Pain Catastrophizing Scale (PCS) score between the 4 groups of subjects included	At baseline	The score varies from 0 to 52 with higher score means High pain catastrophizing.
Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the 4 groups of subjects included.	At baseline	Expressed in IU/ml (International Units per Milliliter)
Quantitative difference Anti-Citrullinated Peptide Antibodies (ACPA) level between the 4 groups of subjects included.	At baseline	Expressed in IU/ml (International Units per Milliliter).
Quantitative difference in C-reactive protein (CRP) level between the 4 groups of subjects included.	At baseline	Expressed in mg/L (milligram per liter)
Quantitative difference in Neutrophils values between the 4 groups of subjects included.	At baseline	Expressed in cells/µL (microliter)
Quantitative difference in lymphocytes values between the 4 groups of subjects included.	At baseline	Expressed in cells/µL (microliter)
Quantitative difference in Platelets (PLT) between the 4 groups of subjects included.	At baseline	Expressed in platelets/µL (microliter)
Clinical arthritis and Clinically Suspected Arthralgias (CSA).	Baseline, week 26; week 52 and week 104 visit	Assess the incidence of clinical arthritis in high-risk RA patients overall (group 1 and 2) and in subgroups according to the presence or absence of CSA and the auto-antibody profile at inclusion. The clinical arthritis is detected by the presence of joints swelling in at least 1 of the 44 joints swelling and confirmed by ultrasound.
Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 100 with higher score means worst pain possible. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 100 with higher score means extreme fatigue. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Pichot Fatigue Scale score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 32 with higher score means severe fatigue. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 20 to 80 with higher score means high anxiety. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 80 with higher score means very severe symptoms (Likely posttraumatic stress disorder (PTSD). Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in patient-reported outcome heath survey Short Form-12 (SF-12) version 2 with Physical Component Summary (PCS) and Mental Component Summary (MCS) scores between the patients who developed clinical arthritis during the 2-year f	Baseline, week 26; week 52 and week 104 visit	The mean is 50 for each score and a standard deviation of 10, a higher score means better health status. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Insomnia Severity Index (ISI) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 28 with higher score means Severe insomnia. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Pain Catastrophizing Scale (PCS) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26; week 52 and week 104 visit	The score varies from 0 to 52 with higher score means High pain catastrophizing. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in tender joints count between the patients who developed clinical arthritis during the 2-year follow-up and those who did not, among 44 joints across the body.	Baseline, week 26, week 52 and week 104 visit	The score varies from 0 to 44 with higher score means more active inflammatory joint disease. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in tenosynovitis count between the patients who developed clinical arthritis during the 2-year follow-up and those who did not, among 16 flexor and extensor finger's tendons.	Baseline, week 26, week 52 and week 104 visit	The score varies from 0 to 44 with higher score means more active inflammatory joint disease. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in difficulties of making a fist between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis.	Baseline, week 26, week 52 and week 104 visit
Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not detected by ultrasound. Relate this outcome to the risk of developing clinical arthritis	Baseline, week 26; week 52 and week 104 visit
Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26, week 52 and week 104 visit	Expressed in IU/ml (International Units per Milliliter).Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Anti-Citrullinated Peptide Antibodies (ACPA) level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26, week 52 and week 104 visit	Expressed in IU/ml (International Units per Milliliter) Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in C-reactive protein (CRP) level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26, week 52 and week 104 visit	Expressed in mg/L (milligram per liter) Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Neutrophils values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26, week 52 and week 104 visit	Expressed in cells/µL (microliter).Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in lymphocytes values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26, week 52 and week 104 visit	Expressed in cells/µL (microliter). Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in Platelets (PLT) between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline, week 26, week 52 and week 104 visit	Expressed in platelets/µL (microliter), Relate this outcome to the risk of developing clinical arthritis.
Proportion of patients with ultrasound synovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).	Baseline, week 26, week 52 and week 104 visit	Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations, between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis.
Proportion of patients with ultrasound tenosynovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).	Baseline, week 26, week 52 and week 104 visit	Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations, between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis.
Proportion of patients with ultrasound synovitis in the 4 groups of subjects included.	Baseline	Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations. Relate this outcome to the risk of developing clinical arthritis.
Proportion of patients with ultrasound tenosynovitis in the 4 groups of subjects included.	Baseline	Detected by ultrasound in mode B and Doppler on the hand's and feet's articulations with semi-quantitative gradation according to Outcome Measures in Rheumatology (OMERACT) recommendations. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in synovitis between the 4 groups of subjects included.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in bone oedemes between the 4 groups of subjects included.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in pinch between the 4 groups of subjects included.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in erosion between the 4 groups of subjects included.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in tenosynovitis between the 4 groups of subjects included, between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in synovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in bone oedemes between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in pinch between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in erosion between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.
Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.	Baseline	Detected by Magnetic Resonance Imaging (MRI) on the dominant hand or the most painful hand. Relate this outcome to the risk of developing clinical arthritis.

Trial Locations

Locations (1)

CHU Montpellier; 🇫🇷 Montpellier, Hérault, France