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Completed

NCT Number: NCT03004651

BMI and Ultrasound/Clinical Assessments of RA Disease Activity

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.

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Key information

Conditions

Obsessional Erotomania

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Regional Hospital Lapeyronie

Montpellier, Languedoc-Roussillon, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Power Doppler ultrasound

Other

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

Clinical evaluation

Other

swollen joint count (SJC) as componant of SDAI

Primary outcomes

  1. Comparison of the level of agreement between the number of abnormal joints and clinical evaluation

    Time frame: 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 outcomes

  1. Comparison of the level of agreement between clinical and ultrasound findings on function of patient's weight

    Time frame: 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

  2. Impact of other factors on the level of agreement between Power Doppler ultrasound and clinical exam

    Time frame: 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

  3. Reproducibility of the comparison between Ultrasound and clinical examination

    Time frame: 18 months

    Reliability between Ultrasound and clinical examination across the different investigation centers

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

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

Registry information

Official study title

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

Acronym: RABODI

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 29, 2016
Registry last updated
May 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.