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Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus

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.
ClinicalTrials.gov Identifier: NCT01471301
Recruitment Status : Unknown
Verified November 2011 by Ana Leticia Pirozzi Buosi, Federal University of São Paulo.
Recruitment status was:  Recruiting
First Posted : November 15, 2011
Last Update Posted : November 15, 2011
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate ultrasound hands in patients with systemic lupus erythematosus.

Condition or disease
Lupus Erythematosus, Systemic Arthritis, Rheumatoid

Detailed Description:

Introduction: The systemic lupus erythematosus (SLE) is a disease with a common articular involvement. Approximately 1-2% of patients with SLE have joint inflammation similar to rheumatoid arthritis (RA). There are no well-designed studies of lupus arthropathy.

Primary objectives: To evaluate the ultrasonographic examination of the hands in patients with systemic lupus erythematosus and make its correlation with examination of patients with rheumatoid arthritis (RA) established and with clinical, serological, radiological and functional.

Material and methods: a transversal study will be carried out on patients diagnosed with with SLE and RA.

Clinical Instruments: count of swollen and tender joints, visual analogue scale (VAS) for pain (0-10 cm), edema and for disease activity; disease activity (DAS 28 and SLEDAI), hand grip strength and pinch (Jamar dynamometer and Preston Pinch Gauge); functional questionnaires (HAQ and DASH). It will be observed the presence of "puffy hands", Raynaud's phenomenon and presence of autoantibodies.

Radiographic instruments: evaluation of radiographs of hands and wrists according to the Sharp score modified by van der Heijde. Ultrasonographic Instruments (quantitative and semi-quantitative measures): synovial hyperplasia, synovial blood flow (Power Doppler), bone erosions and cartilage. The joints that will be evaluated: radiocarpal, distal radioulnar, first to fifth metacarpophalangeal and proximal interphalangeal. Ultrasonographic interobserver reproducibility will be carried out in 10% of the patients. All the examinators will be blind for each other findings. Rheumatoid factor and anti-CCP will be investigated in RA patients. Statistical significance will be set at 5%.

Study Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Ultrasound Evaluation of Hands in Patients With Systemic Lupus Erythematosus
Study Start Date : June 2011
Estimated Primary Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus Ultrasound
U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Biospecimen Retention:   Samples With DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
ambulatory rheumatology

Inclusion Criteria:

  • age between 18 and 60 years;
  • female and male;
  • patients with SLE, according to the revised classification criteria of the ACR (Arthritis Rheum, 1997) with current or previous joint activity (arthritis or arthralgia;
  • patients with established RA according to ACR classification criteria (Arthritis Rheum, 1988)

Exclusion Criteria:

  • changing the dose or drug-based immunosuppression in the last 3 months.
  • corticosteroid pulse therapy in the last 30 days;
  • infiltration with corticosteroids at hand in the last 3 months;
  • previous surgery in the joints studied;
  • irreducible deformity of the joints studied;
  • overlap with other joint diseases or collagen;
  • chiropractic diabetic;
  • hypothyroidism
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01471301

Contact: Ana Leticia Pirozzi Buosi 551181352131 ana_buosi@yahoo.com.br

Unifesp Recruiting
Sao Paulo, Brazil
Contact: Ana Leticia Piirozzi Buosi    551181352131      
Sponsors and Collaborators
Federal University of São Paulo
Principal Investigator: Ana Letícia Pirozzi Buosi Outros
More Information

Responsible Party: Ana Leticia Pirozzi Buosi, Ultrasound evaluation of hands in patients with Systemic Lupus Erythematosus, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01471301     History of Changes
Other Study ID Numbers: ABuosi
First Posted: November 15, 2011    Key Record Dates
Last Update Posted: November 15, 2011
Last Verified: November 2011

Keywords provided by Ana Leticia Pirozzi Buosi, Federal University of São Paulo:
systemic lupus erythematosus
rheumatoid arthritis

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