BMI and Ultrasound/Clinical Assessments of RA Disease Activity (RABODI)

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

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.

Study Overview

• Status: Completed
• Conditions: Obsessional Erotomania
• Intervention / Treatment: Other: Power Doppler ultrasound; Other: Clinical evaluation

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 Type: Observational
• Enrollment (Actual): 121

Contacts and Locations

Study Locations

• France
  • Languedoc-Roussillon
    • Montpellier, Languedoc-Roussillon, France, 34295
      • University Regional Hospital Lapeyronie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obese Patients; Power Doppler ultrasound on obese patients with PR comparating with a clinical evaluation (swollen joint count (SJC) as componant of SDAI)	Other: Power Doppler ultrasound; Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale); Other: 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)	Other: Power Doppler ultrasound; Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale); Other: Clinical evaluation; swollen joint count (SJC) as componant of SDAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Reproducibility of the comparison between Ultrasound and clinical examination	Reliability between Ultrasound and clinical examination across the different investigation centers	18 months

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Central Hospital, Nancy, France; Centre Hospitalier de la côte Basque; University Hospital, Grenoble; Rennes University Hospital; Nantes University Hospital; Centre Hospitalier Lyon Sud; Pitié-Salpêtrière Hospital; Hospital Purpan; Hospital Ambroise Paré Paris; CHU Brest Hôpital La Cavale Blanche
• Investigators: Principal Investigator: Gaël MOUTERDE, PH, CHU de Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 3, 2017
• Primary Completion (ACTUAL): February 20, 2018
• Study Completion (ACTUAL): February 20, 2018

Study Registration Dates

• First Submitted: December 7, 2016
• First Submitted That Met QC Criteria: December 22, 2016
• First Posted (ESTIMATE): December 29, 2016

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 9742 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO