BMI and Ultrasound/Clinical Assessments of RA Disease Activity

Completed

• Conditions: Obsessional Erotomania
• Interventions: Other: Power Doppler ultrasound; Other: Clinical evaluation

• Registration Number: NCT03004651
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2016-12-07
• Study First Submitted QC: 2016-12-22
• Study First Posted: 2016-12-29
• Study Start: 2017-03-03
• Primary Completion: 2018-02-20
• Study Completion: 2018-02-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-07
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 121

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obese Patients	Clinical evaluation	Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
Non obese patients	Clinical evaluation	Power Doppler ultrasound on non obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
Obese Patients	Power Doppler ultrasound	Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)
Non obese patients	Power Doppler ultrasound	Power Doppler ultrasound on non obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)

Primary Outcome Measures

Name	Time	Method
Comparison of the level of agreement between the number of abnormal joints and clinical evaluation	18 months	Comparison 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 Outcome Measures

Name	Time	Method
Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight	18 months	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
Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam	18 months	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
Reproducibility of the comparison between Ultrasound and clinical examination	18 months	Reliability between Ultrasound and clinical examination across the different investigation centers

Trial Locations

Locations (1)

University Regional Hospital Lapeyronie; 🇫🇷 Montpellier, Languedoc-Roussillon, France