BMI and Ultrasound/Clinical Assessments of RA Disease Activity
Condition: Obsessional Erotomania
Study type: Observational

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
    

Intervention name(s): Power Doppler ultrasound; Clinical evaluation
Intervention type(s): Other; Other
Intervention description(s): Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale); swollen joint count (SJC) as componant of SDAI
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.