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Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
FLAVIA SOARES MACHADO, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01476865
First received: November 18, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 18, 2011
November 18, 2011
March 2010
June 2011   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
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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.

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.
Observational
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

serum
Non-Probability Sample

terciary care clinic (rheumatoid arthritis patients) community sample (healthy people)
  • Disorders of Synovium, Multiple Sites
  • Disorders of Subchondral Bone, Multiple Sites
  • Disorders of Cartilage, Hand Joints
  • Arthritis, Rheumatoid
  • Healthy People
Not Provided
  • Healthy
    normal, healthy people
  • RA
    rheumatoid arthritis patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
190
June 2011
June 2011   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01476865
1295/09
No
FLAVIA SOARES MACHADO, Federal University of São Paulo
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
Federal University of São Paulo
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP