Clinical trial NCT03004651: BMI and Ultrasound/Clinical Assessments of RA Disease Activity
Official title: Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obsessional Erotomania
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Pitié-Salpêtrière Hospital
name: Hospital Ambroise Paré Paris
name: Nantes University Hospital
name: Rennes University Hospital
name: University Hospital, Grenoble
name: CHU Brest Hôpital La Cavale Blanche
name: Hospital Purpan
name: Centre Hospitalier Lyon Sud
name: Central Hospital, Nancy, France
name: Centre Hospitalier de la côte Basque
First posted: 2016-12-29
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of the level of agreement between the number of abnormal joints and clinical evaluation
timeFrame: 18 months
Secondary outcomes:
measure: Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight
timeFrame: 18 months
measure: Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam
timeFrame: 18 months
measure: Reproducibility of the comparison between Ultrasound and clinical examination
timeFrame: 18 months
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University Regional Hospital Lapeyronie
state: Languedoc-Roussillon
Study officials:
affiliation: CHU de Montpellier
name: Gaël MOUTERDE, PH
role: PRINCIPAL_INVESTIGATOR
References: