BMI and Ultrasound/Clinical Assessments of RA Disease Activity

NCT03004651 | Completed

• 1 other identifier: 9742
• Study Type: observational
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Obsessional Erotomania

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

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

  18 months

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

  18 months

• Reproducibility of the comparison between Ultrasound and clinical examination

  18 months

Study Arms (2)

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; Other: Clinical evaluation

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; Other: Clinical evaluation

Interventions

Power Doppler ultrasound OTHER

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

Non obese patients; Obese Patients

Clinical evaluation OTHER

swollen joint count (SJC) as componant of SDAI

Non obese patients; Obese Patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• RA patients fulfilling ACR/EULAR 2010 criteria

You may not qualify if:

• Patient simultaneously included in another study with blinded treatment; Steinbrocker class IV patients, pregnancy.

Sponsors & Collaborators

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

Study Sites (1)

University Regional Hospital Lapeyronie

Montpellier, Languedoc-Roussillon, 34295, France

Location

Study Officials

• Gaël MOUTERDE, PH

  CHU de Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2016
• First Posted: December 29, 2016
• Study Start: March 3, 2017
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: May 14, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)