deltatrials
Completed OBSERVATIONAL NCT03004651

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

Sponsor: CHU Brest Hôpital La Cavale Blanche

Updated 9 times since 2017 Last updated: May 7, 2018 Started: Mar 3, 2017 Primary completion: Feb 20, 2018 Completion: Feb 20, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A observational or N/A phase clinical study on Obsessional Erotomania, this trial is completed. The trial is conducted by CHU Brest Hôpital La Cavale Blanche and has accumulated 9 data snapshots since 2017. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Study Description(click to expand)

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...

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

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotNot Yet Recruiting~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshotNot Yet Recruiting~Apr 2017 – ~Apr 2018 · 12 months · monthly snapshotRecruiting~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshotRecruiting~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed

  2. Sep 2024 — Present [monthly]

    Completed

  3. Jul 2024 — Sep 2024 [monthly]

    Completed

  4. Jan 2021 — Jul 2024 [monthly]

    Completed

  5. Jun 2018 — Jan 2021 [monthly]

    Completed

    Status: RecruitingCompleted

Show 4 earlier versions
  1. Apr 2018 — Jun 2018 [monthly]

    Recruiting

    Phase: NANone

  2. Apr 2017 — Apr 2018 [monthly]

    Recruiting NA

    Status: Not Yet RecruitingRecruiting

  3. Feb 2017 — Apr 2017 [monthly]

    Not Yet Recruiting NA

  4. Jan 2017 — Feb 2017 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • 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
  • University Hospital, Montpellier
Data source: University Hospital, Montpellier

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations