BMI and Ultrasound/Clinical Assessments of RA Disease Activity
NCT ID: NCT03004651
Last Updated: 2018-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
121 participants
OBSERVATIONAL
2017-03-03
2018-02-20
Brief Summary
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Detailed Description
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Objectives:
Primary end point: Comparison of the level of agreement between the number of joints considered abnormal by Power Doppler ultrasound synovitis (≥ grade 1 on a semi-quantitative scale) and clinical examination (swollen joint count (SJC) as componant of SDAI) in obese (i.e. BMI\>30) versus normally weighted RA patients.
Secondary end points :
* Comparison of the level of agreement between clinical and ultrasound findings in overweighted versus normally weighted patients, when joint count evaluation is based on another composite index ((DAS28-CRP et DAS44-CRP), based on the number of tender joints, and based on a joint by joint evaluation
* Comparison of agreement between obese and non obese
* Evaluation of the impact of other factors than BMI on the level of agreement between Power Doppler ultrasound defined number of synovitis and clinically defined swollen joint count
* Reliability between Ultrasound and clinical examination across the different investigation centers Study design: prospective multicenter observational study Inclusion criteria: RA patients fulfilling ACR/EULAR 2010 criteria Exclusion criteria: patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients Outcome measure : Level of agreement between SJC and power Doppler US synovitis
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Obese Patients
Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
Power Doppler ultrasound
Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)
Clinical evaluation
swollen joint count (SJC) as componant of SDAI
Non obese patients
Power Doppler ultrasound on non obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
Power Doppler ultrasound
Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)
Clinical evaluation
swollen joint count (SJC) as componant of SDAI
Interventions
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Power Doppler ultrasound
Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)
Clinical evaluation
swollen joint count (SJC) as componant of SDAI
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
80 Years
ALL
No
Sponsors
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Pitié-Salpêtrière Hospital
OTHER
Hospital Ambroise Paré Paris
OTHER
Nantes University Hospital
OTHER
Rennes University Hospital
OTHER
University Hospital, Grenoble
OTHER
CHU Brest Hôpital La Cavale Blanche
UNKNOWN
Hospital Purpan
OTHER
Centre Hospitalier Lyon Sud
OTHER
Central Hospital, Nancy, France
OTHER
Centre Hospitalier de la côte Basque
OTHER
University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Gaël MOUTERDE, PH
Role: PRINCIPAL_INVESTIGATOR
CHU de Montpellier
Locations
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University Regional Hospital Lapeyronie
Montpellier, Languedoc-Roussillon, France
Countries
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Other Identifiers
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9742
Identifier Type: -
Identifier Source: org_study_id
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