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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01476865
Other study ID # 1295/09
Secondary ID
Status Completed
Phase N/A
First received November 18, 2011
Last updated November 18, 2011
Start date March 2010
Est. completion date June 2011

Study information

Verified date November 2011
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial Summary

The purpose of this study is to establish the normality of sonographic synovial measures in joints more affected in rheumatoid arthritis patients and establish, in those joints, a sonographic value of synovium predictive of rheumatoid arthritis.


Description:

Rheumatoid arthritis (RA) is a chronic inflammatory, systemic and auto-imune disorder affecting primarily the joints. In RA, inflammatory synovium causes destruction of cartilage, erosion of the adjacent bone and ultimately loss of function of the affected joint. Newer imaging techniques, such as ultrasound (US), have shown promise in evaluation of RA. Many US scoring system have been used to classify and quantify the synovium, effusion, erosion and cartilage for assessing and monitoring AR. However, its use is considered problematical because there are very few data on normal joints and, at this point, there is no clear definition of excess amount of synovium in normal people.


Recruitment information / eligibility

Status Completed
Enrollment 190
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- no articular disease (healthy group)

- establish rheumatoid arthritis (RA group)

Exclusion Criteria:

- diabetes

- hypothyroidism- hemophilia

- pregnancy

- previous septic arthritis

- previous articular surgery

- symptomatic osteoarthritis

- no superimposed collagenoses (RA group)

Study Design

Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Federal University of São Paulo Fundação de Amparo à Pesquisa do Estado de São Paulo
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