Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01476865
Recruitment Status : Completed
First Posted : November 22, 2011
Last Update Posted : November 22, 2011
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
FLAVIA SOARES MACHADO, Federal University of São Paulo

Brief 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.

Condition or disease
Disorders of Synovium, Multiple Sites Disorders of Subchondral Bone, Multiple Sites Disorders of Cartilage, Hand Joints Arthritis, Rheumatoid Healthy People

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
Actual Enrollment : 190 participants
Time Perspective: Cross-Sectional
Official Title: Articular Sonography: Findings in Healthy Subjects Compared With Rheumatoid Arthritis Patients
Study Start Date : March 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

normal, healthy people
rheumatoid arthritis patients

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01476865

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

Responsible Party: FLAVIA SOARES MACHADO, Flávia Soares Machado, Federal University of São Paulo Identifier: NCT01476865     History of Changes
Other Study ID Numbers: 1295/09
First Posted: November 22, 2011    Key Record Dates
Last Update Posted: November 22, 2011
Last Verified: November 2011

Additional relevant MeSH terms:
Arthritis, Rheumatoid
Cartilage Diseases
Pathologic Processes
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases