National Cohort of Subjects at Risk of Developing Rheumatoid Arthritis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Risk of developing clinical arthritis
研究概览
简要总结
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.
详细描述
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...
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Blood test (Biological)
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.
干预措施: Urine test (Biological)
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.
干预措施: stool collection (Other)
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.
干预措施: saliva collection (Other)
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.
干预措施: Induced expectoration (Other)
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.
干预措施: Hair and nails sampling (Other)
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.
干预措施: Schirmer test (Other)
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.
干预措施: Ultrasound of hands and feet (Radiation)
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.
干预措施: MRI Contrast (Radiation)
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.
干预措施: Patient questions (Other)
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.
干预措施: Dental panoramic X-ray (Diagnostic Test)
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.
干预措施: Consultation with a psychologist in certain centers (Other)
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.
干预措施: Measurement of heart rate variability. (Other)
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.
干预措施: Blood test (Biological)
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.
干预措施: Urine test (Biological)
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.
干预措施: stool collection (Other)
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.
干预措施: saliva collection (Other)
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.
干预措施: Induced expectoration (Other)
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.
干预措施: Hair and nails sampling (Other)
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.
干预措施: Schirmer test (Other)
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.
干预措施: Ultrasound of hands and feet (Radiation)
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.
干预措施: MRI Contrast (Radiation)
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.
干预措施: Patient questions (Other)
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.
干预措施: Dental panoramic X-ray (Diagnostic Test)
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.
干预措施: Consultation with a psychologist in certain centers (Other)
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.
干预措施: Measurement of heart rate variability. (Other)
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).
干预措施: Blood test (Biological)
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).
干预措施: Urine test (Biological)
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).
干预措施: stool collection (Other)
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).
干预措施: saliva collection (Other)
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).
干预措施: Induced expectoration (Other)
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).
干预措施: Hair and nails sampling (Other)
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).
干预措施: Schirmer test (Other)
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).
干预措施: Ultrasound of hands and feet (Radiation)
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).
干预措施: MRI Contrast (Radiation)
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).
干预措施: Patient questions (Other)
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).
干预措施: Consultation with a psychologist in certain centers (Other)
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).
干预措施: Measurement of heart rate variability. (Other)
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).
干预措施: Blood test (Biological)
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).
干预措施: Urine test (Biological)
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).
干预措施: stool collection (Other)
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).
干预措施: saliva collection (Other)
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).
干预措施: Induced expectoration (Other)
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).
干预措施: Hair and nails sampling (Other)
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).
干预措施: Schirmer test (Other)
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).
干预措施: Ultrasound of hands and feet (Radiation)
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).
干预措施: MRI Contrast (Radiation)
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).
干预措施: Patient questions (Other)
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).
干预措施: Dental panoramic X-ray (Diagnostic Test)
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).
干预措施: Consultation with a psychologist in certain centers (Other)
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).
干预措施: Measurement of heart rate variability. (Other)
结局指标
主要结局
Risk of developing clinical arthritis
时间窗: 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.
次要结局
- Quantitative difference in Food Frequency Questionnaire (FFQ) between the 4 groups of subjects included, varying from never or rarely to daily or multiple times per day.(At baseline)
- Quantitative difference in National Observatory for Physical Activity and Sedentariness -Physical Activity Questionnaire (ONAPS-PAQ) expressed in MET (Metabolic Equivalent of Task) per week between the 4 groups of subjects included.(At baseline)
- Quantitative difference in patient-reported exposure outcome Alcohol and Substance Involvement Screening Test (ASSIST) score between the 4 groups of subjects included.(At baseline)
- Quantitative difference in Fagerström Test for Nicotine Dependence (FTND) score between the 4 groups of subjects included.(At baseline)
- Compare the exposure to pollution between the 4 groups of subjects included. "Exposure to pollution will be assessed by cross-referencing residential addresses with the Chimère database.(At baseline)
- Qualitative difference in a self-report integrated questionnaire for diagnosis of all functional gastrointestinal disorders in adults between the 4 groups of subjects included.(At baseline)
- Quantitative difference in patient-reported Francis score for Irritable Bowel Syndrome (IBS) between the 4 groups of subjects included.(At baseline)
- Qualitative difference in patient-reported clinical outcome of Sleep Apnea (Berlin questionnaire) between the 4 groups of subjects included.(At baseline)
- Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the 4 groups of subjects included.(At baseline)
- Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the 4 groups of subjects included.(At baseline)
- Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the 4 groups of subjects included.(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.(At baseline)
- Quantitative difference in Pichot Fatigue Scale score between the 4 groups of subjects included.(At baseline)
- Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the 4 groups of subjects included.(At baseline)
- Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the 4 groups of subjects included,(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(At baseline)
- Quantitative difference in Insomnia Severity Index (ISI) score between the 4 groups of subjects included(At baseline)
- Quantitative difference in Pain Catastrophizing Scale (PCS) score between the 4 groups of subjects included(At baseline)
- Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the 4 groups of subjects included.(At baseline)
- Quantitative difference Anti-Citrullinated Peptide Antibodies (ACPA) level between the 4 groups of subjects included.(At baseline)
- Quantitative difference in C-reactive protein (CRP) level between the 4 groups of subjects included.(At baseline)
- Quantitative difference in Neutrophils values between the 4 groups of subjects included.(At baseline)
- Quantitative difference in lymphocytes values between the 4 groups of subjects included.(At baseline)
- Quantitative difference in Platelets (PLT) between the 4 groups of subjects included.(At baseline)
- Clinical arthritis and Clinically Suspected Arthralgias (CSA).(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Visual Analog Scale (VAS) score for patient's pain between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Visual Analog Scale (VAS) score for patient's fatigue between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Visual Analog Scale (VAS) score for patient's disease activity between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Visual Analog Scale (VAS) score for disease activity on the opinion of the physician between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Pichot Fatigue Scale score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in State-Trait Anxiety Inventory (STAI) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in patient-reported outcome Posttraumatic Stress Disorder Checklist (PCL-5) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in patient-reported outcome heath survey Short Form-12 (SF-12) version 2 with Physical Component Summary (PCS) and Mental Component Summary (MCS) scores between the patients who developed clinical arthritis during the 2-year f(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Insomnia Severity Index (ISI) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Pain Catastrophizing Scale (PCS) score between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in tender joints count between the patients who developed clinical arthritis during the 2-year follow-up and those who did not, among 44 joints across the body.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in tenosynovitis count between the patients who developed clinical arthritis during the 2-year follow-up and those who did not, among 16 flexor and extensor finger's tendons.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in difficulties of making a fist between the patients who developed clinical arthritis during the 2-year follow-up and those who did not. Relate this outcome to the risk of developing clinical arthritis.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not detected by ultrasound. Relate this outcome to the risk of developing clinical arthritis(Baseline, week 26; week 52 and week 104 visit)
- Quantitative difference in Rheumatoid factor (FR) auto-antibody level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in Anti-Citrullinated Peptide Antibodies (ACPA) level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in C-reactive protein (CRP) level between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in Neutrophils values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in lymphocytes values between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26, week 52 and week 104 visit)
- Quantitative difference in Platelets (PLT) between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline, week 26, week 52 and week 104 visit)
- Proportion of patients with ultrasound synovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).(Baseline, week 26, week 52 and week 104 visit)
- Proportion of patients with ultrasound tenosynovitis in the 2 groups at high-risk of rheumatoid factor (RA) (group 1 and 2).(Baseline, week 26, week 52 and week 104 visit)
- Proportion of patients with ultrasound synovitis in the 4 groups of subjects included.(Baseline)
- Proportion of patients with ultrasound tenosynovitis in the 4 groups of subjects included.(Baseline)
- Quantitative difference in synovitis between the 4 groups of subjects included.(Baseline)
- Quantitative difference in bone oedemes between the 4 groups of subjects included.(Baseline)
- Quantitative difference in pinch between the 4 groups of subjects included.(Baseline)
- Quantitative difference in erosion between the 4 groups of subjects included.(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.(Baseline)
- Quantitative difference in synovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline)
- Quantitative difference in bone oedemes between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline)
- Quantitative difference in pinch between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline)
- Quantitative difference in erosion between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline)
- Quantitative difference in tenosynovitis between the patients who developed clinical arthritis during the 2-year follow-up and those who did not.(Baseline)
- Analyzing heart rate variability as a risk factor for developing RA(Baseline)
- Analyze environmental factors associated with the risk of developing clinical arthritis.(Baseline, week 26, week 52 and week 104 visit)