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Articular Sonography: Healthy Subjects Versus Rheumatoid Arthritis Patients

NCT ID: NCT01476865

Last Updated: 2011-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

190 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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

Study Design

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Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Healthy

normal, healthy people

No interventions assigned to this group

RA

rheumatoid arthritis patients

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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FLAVIA SOARES MACHADO

Flávia Soares Machado

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamil Natour, professor

Role: STUDY_CHAIR

Federal University of São Paulo

Rita NV Furtado, PhD

Role: STUDY_CHAIR

Federal University of São Paulo

Flávia S Machado, master

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Other Identifiers

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1295/09

Identifier Type: -

Identifier Source: org_study_id