Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients

Arthritis, Rheumatoid Clinical Trial

Official title:

Articular Sonography: Findings in Healthy Subjects Compared With Rheumatoid Arthritis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01476865
• Other study ID #: 1295/09
• 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

• Arthritis
• Arthritis, Rheumatoid
• Cartilage Diseases
• Disease
• Disorders of Cartilage, Hand Joints
• Disorders of Subchondral Bone, Multiple Sites
• Disorders of Synovium, Multiple Sites
• Healthy People

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