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NCT Number: NCT06876064

National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis

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.

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Key information

Conditions

Rheumatoid Arthritis (RA) Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Montpellier

Montpellier, Hérault, 34000, France

Location contact

CLAIRE DAIEN, PROFESSOR

PRINCIPAL_INVESTIGATOR

CLAIRE DAIEN, Professor

CONTACT

[email protected]

+33 6 85 40 27 87

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

blood test

Biological

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

Biological

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

Stool collection

Other

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

Saliva Collection

Other

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

Induced expectoration

Other

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

Hair and nails samples will be collected.

Schirmer test

Other

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

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

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).

Primary outcomes

  1. Risk of developing clinical arthritis

    Time frame: 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 outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

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

    Time frame: At baseline

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

  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.

    Time frame: 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.

    Time frame: At baseline

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

  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.

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

  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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

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

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

    Time frame: At baseline

    Expressed in IU/ml (International Units per Milliliter)

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

    Time frame: At baseline

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

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

    Time frame: At baseline

    Expressed in mg/L (milligram per liter)

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

    Time frame: At baseline

    Expressed in cells/µL (microliter)

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

    Time frame: At baseline

    Expressed in cells/µL (microliter)

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

    Time frame: At baseline

    Expressed in platelets/µL (microliter)

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

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

  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.

    Time frame: 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.

  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.

    Time frame: 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.

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

    Time frame: Baseline, week 26, week 52 and week 104 visit

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

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

    Time frame: Baseline, week 26, week 52 and week 104 visit

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

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

    Time frame: Baseline, week 26, week 52 and week 104 visit

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

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

  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.

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Baseline

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

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

    Time frame: Baseline, week 26, week 52 and week 104 visit

    Exposure will be assessed using partial addresses

Study contacts

Contact information is provided by the study sponsor or research team.

CLAIRE DAIEN, PROFESSOR

CONTACT

[email protected]

00 33 6 85 40 27 87

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Assistance Publique - Hôpitaux de Paris
  • Assistance Publique Hopitaux De Marseille
  • Bicetre Hospital
  • Groupe Hospitalier Pitie-Salpetriere
  • Hôpital Cochin
  • Nantes University Hospital
  • Saint Antoine University Hospital
  • University Hospital, Bordeaux
  • University Hospital, Brest
  • University of New Orleans

Registry information

Acronym: PROMESS_1

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 14, 2025
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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