BMI and Ultrasound/Clinical Assessments of RA Disease Activity

Obsessional Erotomania Clinical Trial

— RABODI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03004651
• Other study ID #: 9742
• Status: Completed
• Start date: March 3, 2017
• Est. completion date: February 20, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obsessional Erotomania

Intervention

Other:
• Power Doppler ultrasound
Mesure of synovitis (= grade 1 synovitis on a semi-quantitative scale)
• Clinical evaluation
swollen joint count (SJC) as componant of SDAI

Locations

Country	Name	City	State
France	University Regional Hospital Lapeyronie	Montpellier	Languedoc-Roussillon

Sponsors (11)

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

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the level of agreement between the number of abnormal joints and clinical evaluation	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	18 months
Secondary	Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight	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	18 months
Secondary	Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam	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	18 months
Secondary	Reproducibility of the comparison between Ultrasound and clinical examination	Reliability between Ultrasound and clinical examination across the different investigation centers	18 months