Obsessional Erotomania Clinical Trial
— RABODIOfficial title:
Impact of Body Mass Index on the Agreement Between Ultrasound- and Clinical Assessments of Disease Activity in RA : Cross-sectionnal Study
NCT number | NCT03004651 |
Other study ID # | 9742 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 3, 2017 |
Est. completion date | February 20, 2018 |
Verified date | May 2018 |
Source | University Hospital, Montpellier |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 121 |
Est. completion date | February 20, 2018 |
Est. primary completion date | February 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
France | University Regional Hospital Lapeyronie | Montpellier | Languedoc-Roussillon |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier | Central Hospital, Nancy, France, Centre Hospitalier de la côte Basque, Centre Hospitalier Lyon Sud, CHU Brest Hôpital La Cavale Blanche, Hospital Ambroise Paré Paris, Hospital Purpan, Nantes University Hospital, Pitié-Salpêtrière Hospital, Rennes University Hospital, University Hospital, Grenoble |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Reproducibility of the comparison between Ultrasound and clinical examination | Reliability between Ultrasound and clinical examination across the different investigation centers | 18 months |