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Rheumatoid Arthritis (RA)PROMESS_1NCT06876064

National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

An observational study of Rheumatoid Arthritis (RA), run by University Hospital, Montpellier at 1 site in France.

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Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Rheumatoid Arthritis (RA)
What is being tested?
Blood test, Urine test and stool collection
How many people
150 participants
Where
1 siteFrance
Study dates
7 Oct 2025to Dec 2029
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The patients will be recruted during consultation or hospitalization.

Who may be able to join

  • 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).

Who cannot join

  • 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.)
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

CLAIRE IMMEDIATO DAIEN, PROFESSOR contact

00 33 6 85 40 27 87

c-daien@chu-montpellier.fr

France1 site, 1 recruiting

  • CHU Montpellier

    Montpellier, Hérault, 34000

    CLAIRE DAIEN, Professor, +33 6 85 40 27 87, c-daien@chu-montpellier.fr

    CLAIRE DAIEN, PROFESSOR

    Recruiting

Other trials in France

About this study

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.

Read more

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.
Read the 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), plus an additional visit in case of suspected arthritis. 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-mannitol 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.

Exploratory objectives: blood and pulmonary immunobiological characteristics (immunophenotyping on fresh blood in selected centers); environmental exposure assessed with partial addresses (street and city names of homes and workplaces); psychological, psychiatric and psychosomatic factors. Exploratory predictive modelling (penalized regression, random forest, gradient boosting) will complement the confirmatory analyses after database lock.

Being tested
Blood test, Urine test, stool collection, saliva collection, Induced expectoration
Keywords
at-risk, ACPA, Rheumatoid arthritis, Exposome, Prediction
Medical subject headings
Arthritis, Rheumatoid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood testBiological

    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 testBiological

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

  • stool collectionOther

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

  • saliva collectionOther

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

  • Induced expectorationOther

    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 samplingOther

    Hair and nails samples will be collected.

  • Schirmer testOther

    To assess of tear secretion

  • Ultrasound of hands and feetRadiation

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

  • MRI ContrastRadiation

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

  • Patient questionsOther

    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-rayDiagnostic test

    Performed as part of routine care to assess dental health

  • Consultation with a psychologist in certain centersOther

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

  • Measurement of heart rate variability.Other

    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)Behavioural

    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 groups in NCT06876064
Study groupRoleWhat they receive
Group 1A 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.
Receives: Biological: Blood test; Biological: Urine test; Other: stool collection; Other: saliva collection; Other: Induced expectoration; Other: Hair and nails sampling; Other: Schirmer test; Radiation: Ultrasound of hands and feet; Radiation: MRI Contrast; Other: Patient questions; Diagnostic Test: Dental panoramic X-ray; Other: Consultation with a psychologist in certain centers; Other: Measurement of heart rate variability.; Behavioral: Behavioral: semi-structured psychological interview (1 h, teleconsultation)
Group 2A 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.
Receives: Biological: Blood test; Biological: Urine test; Other: stool collection; Other: saliva collection; Other: Induced expectoration; Other: Hair and nails sampling; Other: Schirmer test; Radiation: Ultrasound of hands and feet; Radiation: MRI Contrast; Other: Patient questions; Diagnostic Test: Dental panoramic X-ray; Other: Consultation with a psychologist in certain centers; Other: Measurement of heart rate variability.; Behavioral: Behavioral: semi-structured psychological interview (1 h, teleconsultation)
Group 3A total 25 subjects will be recruited: asymptomatic subjects (CSA criteria <4) with a family history of RA in a first-degree relative (negative controls).
Receives: Biological: Blood test; Biological: Urine test; Other: stool collection; Other: saliva collection; Other: Induced expectoration; Other: Hair and nails sampling; Other: Schirmer test; Radiation: Ultrasound of hands and feet; Radiation: MRI Contrast; Other: Patient questions; Other: Consultation with a psychologist in certain centers; Other: Measurement of heart rate variability.
Group 4A 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).
Receives: Biological: Blood test; Biological: Urine test; Other: stool collection; Other: saliva collection; Other: Induced expectoration; Other: Hair and nails sampling; Other: Schirmer test; Radiation: Ultrasound of hands and feet; Radiation: MRI Contrast; Other: Patient questions; Diagnostic Test: Dental panoramic X-ray; Other: Consultation with a psychologist in certain centers; Other: Measurement of heart rate variability.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (61)

  1. 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.

    Measured: At baseline

  2. 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.

    Measured: At baseline

  3. 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.

    Measured: At baseline

  4. 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.

    Measured: At baseline

  5. 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.

    Measured: At baseline

  6. Qualitative difference in a self-report integrated questionnaire for diagnosis of all functional gastrointestinal disorders in adults between the 4 groups of subjects included.

    Measured: At baseline

  7. Quantitative difference in patient-reported Francis score for Irritable Bowel Syndrome (IBS) between the 4 groups of subjects included.

    The score varies from 0 to 100 with higher score means severe IBS.

    Measured: At baseline

  8. Qualitative difference in patient-reported clinical outcome of Sleep Apnea (Berlin questionnaire) between the 4 groups of subjects included.

    It is composed of 3 categories of questions, if 2 or more categories are positive it means a high risk of apnea.

    Measured: At baseline

  9. Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the 4 groups of subjects included.

    The score varies from 0 to 100 with higher score means worst pain possible.

    Measured: At baseline

  10. Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the 4 groups of subjects included.

    The score varies from 0 to 100 with higher score means extreme fatigue.

    Measured: At baseline

  11. Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the 4 groups of subjects included.

    The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity).

    Measured: At baseline

  12. Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the 4 groups of subjects included.

    The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity).

    Measured: At baseline

  13. Quantitative difference in Pichot Fatigue Scale score between the 4 groups of subjects included.

    The score varies from 0 to 32 with higher score means severe fatigue.

    Measured: At baseline

  14. Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the 4 groups of subjects included.

    The score varies from 20 to 80 with higher score means high anxiety.

    Measured: At baseline

  15. Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the 4 groups of subjects included,

    The score varies from 0 to 80 with higher score means very severe symptoms (Likely posttraumatic stress disorder (PTSD)).

    Measured: At baseline

  16. 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

    The mean is 50 for each score with a standard deviation of 10, a higher score means better health status.

    Measured: At baseline

  17. Quantitative difference in Insomnia Severity Index (ISI) score between the 4 groups of subjects included

    The score varies from 0 to 28 with higher score means Severe insomnia.

    Measured: At baseline

  18. Quantitative difference in Pain Catastrophizing Scale (PCS) score between the 4 groups of subjects included

    The score varies from 0 to 52 with higher score means High pain catastrophizing.

    Measured: At baseline

  19. Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the 4 groups of subjects included.

    Expressed in IU/ml (International Units per Milliliter)

    Measured: At baseline

  20. Quantitative difference Anti-Citrullinated Peptide Antibodies (ACPA) level between the 4 groups of subjects included.

    Expressed in IU/ml (International Units per Milliliter).

    Measured: At baseline

  21. Quantitative difference in C-reactive protein (CRP) level between the 4 groups of subjects included.

    Expressed in mg/L (milligram per liter)

    Measured: At baseline

  22. Quantitative difference in Neutrophils values between the 4 groups of subjects included.

    Expressed in cells/µL (microliter)

    Measured: At baseline

  23. Quantitative difference in lymphocytes values between the 4 groups of subjects included.

    Expressed in cells/µL (microliter)

    Measured: At baseline

  24. Quantitative difference in Platelets (PLT) between the 4 groups of subjects included.

    Expressed in platelets/µL (microliter)

    Measured: At baseline

  25. Clinical arthritis and Clinically Suspected Arthralgias (CSA).

    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.

    Measured: Baseline, week 26; week 52 and week 104 visit

  26. 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.

    The score varies from 0 to 100 with higher score means worst pain possible. Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26; week 52 and week 104 visit

  27. 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.

    The score varies from 0 to 100 with higher score means extreme fatigue. Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26; week 52 and week 104 visit

  28. 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.

    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.

    Measured: Baseline, week 26; week 52 and week 104 visit

  29. 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.

    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.

    Measured: Baseline, week 26; week 52 and week 104 visit

  30. 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.

    The score varies from 0 to 32 with higher score means severe fatigue. Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26; week 52 and week 104 visit

  31. 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.

    The score varies from 20 to 80 with higher score means high anxiety. Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26; week 52 and week 104 visit

  32. 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.

    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.

    Measured: Baseline, week 26; week 52 and week 104 visit

  33. 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

    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.

    Measured: Baseline, week 26; week 52 and week 104 visit

  34. 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.

    The score varies from 0 to 28 with higher score means Severe insomnia. Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26; week 52 and week 104 visit

  35. 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.

    The score varies from 0 to 52 with higher score means High pain catastrophizing. Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26; week 52 and week 104 visit

  36. 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.

    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.

    Measured: Baseline, week 26, week 52 and week 104 visit

  37. 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.

    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.

    Measured: Baseline, week 26, week 52 and week 104 visit

  38. 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.

    Measured: Baseline, week 26, week 52 and week 104 visit

  39. 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

    Measured: Baseline, week 26; week 52 and week 104 visit

  40. 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.

    Expressed in IU/ml (International Units per Milliliter).Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26, week 52 and week 104 visit

  41. 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.

    Expressed in IU/ml (International Units per Milliliter) Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26, week 52 and week 104 visit

  42. 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.

    Expressed in mg/L (milligram per liter) Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26, week 52 and week 104 visit

  43. Quantitative difference in Neutrophils values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    Expressed in cells/µL (microliter).Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26, week 52 and week 104 visit

  44. Quantitative difference in lymphocytes values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    Expressed in cells/µL (microliter). Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26, week 52 and week 104 visit

  45. Quantitative difference in Platelets (PLT) between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    Expressed in platelets/µL (microliter), Relate this outcome to the risk of developing clinical arthritis.

    Measured: Baseline, week 26, week 52 and week 104 visit

  46. Proportion of patients with ultrasound synovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).

    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.

    Measured: Baseline, week 26, week 52 and week 104 visit

  47. Proportion of patients with ultrasound tenosynovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).

    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.

    Measured: Baseline, week 26, week 52 and week 104 visit

  48. Proportion of patients with ultrasound synovitis in the 4 groups of subjects included.

    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.

    Measured: Baseline

  49. Proportion of patients with ultrasound tenosynovitis in the 4 groups of subjects included.

    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.

    Measured: Baseline

  50. Quantitative difference in synovitis between the 4 groups of subjects included.

    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.

    Measured: Baseline

  51. Quantitative difference in bone oedemes between the 4 groups of subjects included.

    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.

    Measured: Baseline

  52. Quantitative difference in pinch between the 4 groups of subjects included.

    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.

    Measured: Baseline

  53. Quantitative difference in erosion between the 4 groups of subjects included.

    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.

    Measured: Baseline

  54. 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.

    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.

    Measured: Baseline

  55. Quantitative difference in synovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    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.

    Measured: Baseline

  56. Quantitative difference in bone oedemes between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    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.

    Measured: Baseline

  57. Quantitative difference in pinch between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    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.

    Measured: Baseline

  58. Quantitative difference in erosion between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    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.

    Measured: Baseline

  59. Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.

    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.

    Measured: Baseline

  60. Analyzing heart rate variability as a risk factor for developing RA

    Measurement of heart rate variability in high-risk patients (group 1 + group 2) for RA

    Measured: Baseline

  61. Analyze environmental factors associated with the risk of developing clinical arthritis.

    Exposure will be assessed using partial addresses

    Measured: Baseline, week 26, week 52 and week 104 visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Mar 2025
  2. Study start7 Oct 2025
  3. Primary completionDec 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06876064
Sponsor's protocol ID
RECHMPL24_0015
Other IDs
Eudra CT/ID-RCB
Acronym
PROMESS_1
Status last verified
Sep 2026
First submitted
24 Dec 2024
Last updated
1 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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