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BMI and Ultrasound/Clinical Assessments of RA Disease Activity

Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03004651
Acronym
RABODI
Enrollment
121
Registered
2016-12-29
Start date
2017-03-03
Completion date
2018-02-20
Last updated
2018-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obsessional Erotomania

Brief summary

Comparison of the level of agreement between Power Doppler ultrasound measured number of synovitis (≥ grade 1 on a semi-quantitative scale) and clinically defined number of swollen joints in obese (i.e. BMI\>30) versus normally weighted RA patients.

Detailed description

Clinical evaluation of synovitis in rheumatoid arthritis (RA) is difficult in obese and overweighted patients, due to the fat pad located around the joint, that can over- or under estimate the number of joints regarded as swollen by clinical examination. RA in obese and overweighted patients has several distinctive characteristics as compared to the disease observed in normally weighted subjects: diease activity (assessed by composites scores such as Disease Activity Score (DAS28) or Simple Disease Activity Index (SDAI)) is higher, while response to treatment and severity (asessed by radiographic progression) are lower. 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

Interventions

OTHERPower Doppler ultrasound

Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)

OTHERClinical evaluation

swollen joint count (SJC) as componant of SDAI

Sponsors

Pitié-Salpêtrière Hospital
CollaboratorOTHER
Hospital Ambroise Paré Paris
CollaboratorOTHER
Nantes University Hospital
CollaboratorOTHER
Rennes University Hospital
CollaboratorOTHER
University Hospital, Grenoble
CollaboratorOTHER
CHU Brest Hôpital La Cavale Blanche
CollaboratorUNKNOWN
Hospital Purpan
CollaboratorOTHER
Centre Hospitalier Lyon Sud
CollaboratorOTHER
Central Hospital, Nancy, France
CollaboratorOTHER
Centre Hospitalier de la côte Basque
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* RA patients fulfilling ACR/EULAR 2010 criteria

Exclusion criteria

* Patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients, pregnancy.

Design outcomes

Primary

MeasureTime frameDescription
Comparison of the level of agreement between the number of abnormal joints and clinical evaluation18 monthsComparison of the level of agreement between the number of abnormal joints as defined by Power Doppler ultrasound (≥ grade 1 synovitis on a semi-quantitative scale) and clinical evaluation (swollen joint count (SJC) as componant of SDAI) in obese

Secondary

MeasureTime frameDescription
Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight18 monthsComparison 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
Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam18 monthsEvaluation 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
Reproducibility of the comparison between Ultrasound and clinical examination18 monthsReliability between Ultrasound and clinical examination across the different investigation centers

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026