Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Arthritis, Rheumatoid; Healthy People; Disorders of Synovium, Multiple Sites; Disorders of Subchondral Bone, Multiple Sites; Disorders of Cartilage, Hand Joints

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 190

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy; normal, healthy people
RA; rheumatoid arthritis patients

Collaborators and Investigators

• Sponsor: Federal University of São Paulo
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo
• Investigators: Study Chair: Rita NV Furtado, PhD, Federal University of São Paulo; Study Chair: Jamil Natour, professor, Federal University of São Paulo; Principal Investigator: Flávia S Machado, master, Federal University of São Paulo

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 18, 2011
• First Submitted That Met QC Criteria: November 18, 2011
• First Posted (Estimate): November 22, 2011

Study Record Updates

• Last Update Posted (Estimate): November 22, 2011
• Last Update Submitted That Met QC Criteria: November 18, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Disease; Cartilage Diseases
• Other Study ID Numbers: 1295/09