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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
  Purpose

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

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Articular Sonography: Findings in Healthy Subjects Compared With Rheumatoid Arthritis Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Federal University of São Paulo:

Biospecimen Retention:   Samples With DNA

serum


Enrollment: 190
Study Start Date: March 2010
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Healthy
normal, healthy people
RA
rheumatoid arthritis patients

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01476865

Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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
  More Information

No publications provided

Responsible Party: FLAVIA SOARES MACHADO, Flávia Soares Machado, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01476865     History of Changes
Other Study ID Numbers: 1295/09
Study First Received: November 18, 2011
Last Updated: November 18, 2011
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on May 16, 2013