Cohorte nacional de sujetos en riesgo de desarrollar artritis reumatoide (PROMESS_1)
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
- Biológico: Blood test
- Biológico: Urine test
- Otro: stool collection
- Otro: saliva collection
- Otro: Induced expectoration
- Otro: Hair and nails sampling
- Otro: Schirmer test
- Radiación: Ultrasound of hands and feet
- Radiación: MRI Contrast
- Otro: Patient questions
- Prueba de diagnóstico: Dental panoramic X-ray
- Otro: Consultation with a psychologist in certain centers
- Otro: Measurement of heart rate variability.
- Conductual: Behavioral: semi-structured psychological interview (1 h, teleconsultation)
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: CLAIRE IMMEDIATO DAIEN, PROFESSOR
- Número de teléfono: 00 33 6 85 40 27 87
- Correo electrónico: c-daien@chu-montpellier.fr
Ubicaciones de estudio
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-
Hérault
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Montpellier, Hérault, Francia, 34000
- Reclutamiento
- CHU Montpellier
-
Contacto:
- CLAIRE DAIEN, Professor
- Número de teléfono: +33 6 85 40 27 87
- Correo electrónico: c-daien@chu-montpellier.fr
-
Investigador principal:
- CLAIRE DAIEN, PROFESSOR
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
The patients will be recruted during consultation or hospitalization.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Group 1
A total of 50 subjects will be recruited: individuals with ACPA≥2 N and clinically suspect arthralgia (CSA criteria ≥4) or those with ACPA≥N and rheumatoid factor≥2N along with clinically suspect arthralgia (CSA criteria ≥4). These subjects have an estimated 50% risk of progression to RA within 2 years. |
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 will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability. Stool samples will be collected either at the hospital or at home using a dedicated kit. 5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit. 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 samples will be collected. To assess of tear secretion To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis. MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects. 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. Performed as part of routine care to assess dental health The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist. 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). 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) |
|
Group 2
A total of 50 subjects will be recruited: individuals with ACPA≥2 N who do not meet the criteria for clinically suspect arthralgia (CSA criteria <4) or those with ACPA≥N and rheumatoid factor≥2N who also do not meet the criteria for clinically suspect arthralgia (CSA criteria <4). These subjects have an estimated 30% risk of progression to RA within 2 years. |
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 will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability. Stool samples will be collected either at the hospital or at home using a dedicated kit. 5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit. 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 samples will be collected. To assess of tear secretion To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis. MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects. 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. Performed as part of routine care to assess dental health The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist. 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). 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) |
|
Group 3
A total 25 subjects will be recruited: asymptomatic subjects (CSA criteria <4) with a family history of RA in a first-degree relative (negative controls). |
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 will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability. Stool samples will be collected either at the hospital or at home using a dedicated kit. 5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit. 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 samples will be collected. To assess of tear secretion To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis. MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects. 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. The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist. The patient will wear a belt throughout the visit 1. At the end of the day, the heart rate variability data measured by the belt will be recorded in the CRF (RR interval, heart rate variability SDNN, RMSSD, and LF/HF sympathovagal balance). |
|
Group 4
A total of 25 subjects will be recruited: individuals with RA diagnosed at polyarthritis onset (diagnosis <6 months) who have not yet been treated, with ACPA≥2 N or ACPA≥N and rheumatoid factor≥2N (positive controls). |
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 will be collected, while fasting and after the administration of lactulose/ mannitol to assess intestinal permeability. Stool samples will be collected either at the hospital or at home using a dedicated kit. 5 ml of saliva will be collected and saliva microbiome DNA will be collected using an OMNIgene Oral kit. 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 samples will be collected. To assess of tear secretion To assess the risk of RA in high-risk subjects by evaluating for synovitis, tenosynovitis, or intermetatarsal-phalangeal bursitis. MRI of the dominant or painful hand will be performed to assess the risk of RA in high-risk subjects. 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. Performed as part of routine care to assess dental health The short-CTQ will be completed during this consultation, only in centers offering consultations with a psychologist. 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). |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Risk of developing clinical arthritis
Periodo de tiempo: 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. |
From the baseline to the end of the follow-up at 2 years
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Diferencia cuantitativa en el cuestionario de frecuencia alimentaria (FFQ) entre los 4 grupos de sujetos incluidos, que varían de nunca o raramente a diario o varias veces al día.
Periodo de tiempo: Al inicio
|
Al inicio
|
|
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Diferencia cuantitativa en el Observatorio Nacional para la Actividad Física y el Cuestionario de Actividad Física Sedentariedad (ONAPS -PAQ) expresado en Met (equivalente metabólico de la tarea) por semana entre los 4 grupos de sujetos incluidos.
Periodo de tiempo: Al inicio
|
Al inicio
|
|
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Compare la exposición a la contaminación entre los 4 grupos de sujetos incluidos. "La exposición a la contaminación se evaluará mediante direcciones residenciales de referencia cruzada con la base de datos Chimère.
Periodo de tiempo: Al inicio
|
Al inicio
|
|
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Diferencia cualitativa en un cuestionario integrado de autoinforme para el diagnóstico de todos los trastornos gastrointestinales funcionales en adultos entre los 4 grupos de sujetos incluidos.
Periodo de tiempo: Al inicio
|
Al inicio
|
|
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Diferencia cuantitativa en las dificultades de hacer un puño entre los pacientes que desarrollaron artritis clínica durante el seguimiento de 2 años y los que no lo hicieron. Relacione este resultado con el riesgo de desarrollar artritis clínica.
Periodo de tiempo: Basación, Semana 26, Semana 52 y Semana 104 Visita
|
Basación, Semana 26, Semana 52 y Semana 104 Visita
|
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Diferencia cuantitativa en la tenosinovitis entre los pacientes que desarrollaron artritis clínica durante el seguimiento de 2 años y aquellos que no detectaron por ultrasonido. Relacionar este resultado con el riesgo de desarrollar artritis clínica
Periodo de tiempo: Línea de base, semana 26; Semana 52 y semana 104 Visita
|
Línea de base, semana 26; Semana 52 y semana 104 Visita
|
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Quantitative difference in patient-reported exposure outcome Alcohol and Substance Involvement Screening Test (ASSIST) score between the 4 groups of subjects included.
Periodo de tiempo: 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. |
At baseline
|
|
Quantitative difference in Fagerström Test for Nicotine Dependence (FTND) score between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 1 to 6 with higher score indicate greater nicotine dependence. |
At baseline
|
|
Quantitative difference in patient-reported Francis score for Irritable Bowel Syndrome (IBS) between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 0 to 100 with higher score means severe IBS. |
At baseline
|
|
Qualitative difference in patient-reported clinical outcome of Sleep Apnea (Berlin questionnaire) between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
It is composed of 3 categories of questions, if 2 or more categories are positive it means a high risk of apnea. |
At baseline
|
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Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 0 to 100 with higher score means worst pain possible. |
At baseline
|
|
Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 0 to 100 with higher score means extreme fatigue. |
At baseline
|
|
Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). |
At baseline
|
|
Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 0 to 100 with higher score means complete Limitation (Unable to Perform Any Activity). |
At baseline
|
|
Quantitative difference in Pichot Fatigue Scale score between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 0 to 32 with higher score means severe fatigue. |
At baseline
|
|
Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
The score varies from 20 to 80 with higher score means high anxiety. |
At baseline
|
|
Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the 4 groups of subjects included,
Periodo de tiempo: At baseline
|
The score varies from 0 to 80 with higher score means very severe symptoms (Likely posttraumatic stress disorder (PTSD)). |
At baseline
|
|
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
Periodo de tiempo: At baseline
|
The mean is 50 for each score with a standard deviation of 10, a higher score means better health status. |
At baseline
|
|
Quantitative difference in Insomnia Severity Index (ISI) score between the 4 groups of subjects included
Periodo de tiempo: At baseline
|
The score varies from 0 to 28 with higher score means Severe insomnia. |
At baseline
|
|
Quantitative difference in Pain Catastrophizing Scale (PCS) score between the 4 groups of subjects included
Periodo de tiempo: At baseline
|
The score varies from 0 to 52 with higher score means High pain catastrophizing. |
At baseline
|
|
Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
Expressed in IU/ml (International Units per Milliliter) |
At baseline
|
|
Quantitative difference Anti-Citrullinated Peptide Antibodies (ACPA) level between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
Expressed in IU/ml (International Units per Milliliter). |
At baseline
|
|
Quantitative difference in C-reactive protein (CRP) level between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
Expressed in mg/L (milligram per liter) |
At baseline
|
|
Quantitative difference in Neutrophils values between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
Expressed in cells/µL (microliter) |
At baseline
|
|
Quantitative difference in lymphocytes values between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
Expressed in cells/µL (microliter) |
At baseline
|
|
Quantitative difference in Platelets (PLT) between the 4 groups of subjects included.
Periodo de tiempo: At baseline
|
Expressed in platelets/µL (microliter) |
At baseline
|
|
Clinical arthritis and Clinically Suspected Arthralgias (CSA).
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
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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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
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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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26; week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26, week 52 and week 104 visit
|
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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.
Periodo de tiempo: 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. |
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.
Periodo de tiempo: 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. |
Baseline, week 26, week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26, week 52 and week 104 visit
|
|
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.
Periodo de tiempo: 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. |
Baseline, week 26, week 52 and week 104 visit
|
|
Quantitative difference in Neutrophils values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: Baseline, week 26, week 52 and week 104 visit
|
Expressed in cells/µL (microliter).Relate this outcome to the risk of developing clinical arthritis. |
Baseline, week 26, week 52 and week 104 visit
|
|
Quantitative difference in lymphocytes values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: Baseline, week 26, week 52 and week 104 visit
|
Expressed in cells/µL (microliter). Relate this outcome to the risk of developing clinical arthritis. |
Baseline, week 26, week 52 and week 104 visit
|
|
Quantitative difference in Platelets (PLT) between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: Baseline, week 26, week 52 and week 104 visit
|
Expressed in platelets/µL (microliter), Relate this outcome to the risk of developing clinical arthritis. |
Baseline, week 26, week 52 and week 104 visit
|
|
Proportion of patients with ultrasound synovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).
Periodo de tiempo: 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. |
Baseline, week 26, week 52 and week 104 visit
|
|
Proportion of patients with ultrasound tenosynovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).
Periodo de tiempo: 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. |
Baseline, week 26, week 52 and week 104 visit
|
|
Proportion of patients with ultrasound synovitis in the 4 groups of subjects included.
Periodo de tiempo: 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. |
Baseline
|
|
Proportion of patients with ultrasound tenosynovitis in the 4 groups of subjects included.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in synovitis between the 4 groups of subjects included.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in bone oedemes between the 4 groups of subjects included.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in pinch between the 4 groups of subjects included.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in erosion between the 4 groups of subjects included.
Periodo de tiempo: 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. |
Baseline
|
|
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.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in synovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in bone oedemes between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in pinch between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in erosion between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: 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. |
Baseline
|
|
Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.
Periodo de tiempo: 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. |
Baseline
|
|
Analyzing heart rate variability as a risk factor for developing RA
Periodo de tiempo: Baseline
|
Measurement of heart rate variability in high-risk patients (group 1 + group 2) for RA |
Baseline
|
|
Analyze environmental factors associated with the risk of developing clinical arthritis.
Periodo de tiempo: Baseline, week 26, week 52 and week 104 visit
|
Exposure will be assessed using partial addresses |
Baseline, week 26, week 52 and week 104 visit
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Association between comorbidities and medical history
Periodo de tiempo: From the baseline to the end of the follow-up at 2 years
|
(CNAM pathology mapping) and drug exposure (SNDS dispensing data) and the risk of clinical arthritis in Groups 1 and 2." Time frame: SNDS linkage at end of study. |
From the baseline to the end of the follow-up at 2 years
|
|
Association between psychological, psychiatric and psychosomatic factors
Periodo de tiempo: baseline, week 26, week 52 and week 104, depending on the instrument.
|
(BDI, MAIA, QSSP, TAS-20, Cambridge Depersonalization Scale, DES, psychological pain VAS, RFQ-B, affective touch perception test) and the risk of clinical arthritis in Groups 1 and 2, and comparison between groups. |
baseline, week 26, week 52 and week 104, depending on the instrument.
|
|
Association between blood and pulmonary immunobiological characteristics
Periodo de tiempo: baseline
|
(immunophenotyping on fresh blood, induced sputum) and the risk of clinical arthritis in Groups 1 and 2 |
baseline
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades Articulares
- Enfermedades reumáticas
- Enfermedades del tejido conectivo
- Enfermedades autoinmunes
- Enfermedades del sistema inmunológico
- Enfermedades de la piel y del tejido conectivo
- Artritis Reumatoide
- Práctica profesional
- Organización y administración
- Administración de Servicios de Salud
- Prestación de atención médica
- Técnicas de investigación
- Técnicas de laboratorio clínico
- Técnicas y procedimientos de diagnóstico
- Diagnóstico
- Imágenes de diagnóstico
- Fenómenos químicos
- Telemedicina
- Gestión de atención al paciente
- Radiografía
- Técnicas de diagnóstico, urológicos
- Odontología
- Pruebas de química clínica
- Interacciones hidrofóbicas e hidrofílicas
- Propiedades superficiales
- Radiografía, dental
- Diagnóstico, oral
- Referencia y consulta
- Pruebas hematológicas
- Consulta remota
- Análisis de orina
- Humectación
- Radiografía, panorámica
Otros números de identificación del estudio
- RECHMPL24_0015
- Eudra CT/ID-RCB (Otro identificador: 2024-A01176-41)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .