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Painless Synovitis in Patients With Longstanding Rheumatoid Arthritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Federal University of São Paulo.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Daniele Freitas Pereira, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01639287
First received: July 10, 2012
Last updated: July 11, 2012
Last verified: July 2012
  Purpose

There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands.

The objective of this study is to compare painless synovitis with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings.

A sonographic examination (Gray-scale and power Doppler) will be done to evaluate metacarpophalangeal joints of patients without local painful and will be a comparison with patients with local painful.


Condition
- Rheumatoid Arthritis

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Correlation of "Painless" Synovitis With Clinical, Laboratory and Radiological (X-ray, Sonography) Finds in Patients With Longstanding Rheumatoid Arthritis (RA).

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sonographic power Doppler [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Sonographic Gray Scale [ Time Frame: baseline ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

Serum


Estimated Enrollment: 60
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Painless
Painless synovitis group(called "cold" synovitis)
Painful
Painful synovitis group

Detailed Description:

Introduction/Objectives:

There is a group of patients with rheumatoid arthritis (RA) that suffer from chronically painless synovitis in the hands. The mean of this is still unknown and does not exist studies in the literature that assessing the predictors of this behavior or synovial potential to cause bone erosion.

The objective of this study is to compare painless synovitis (called "cold" synovitis) with painful synovitis according to the sonographic (Gray-scale and power Doppler) findings, articular damage (x-Ray and sonography), clinical, laboratory and demographic variables in RA patients.

Methods: Cross-sectional study with RA patients, which will be evaluated metacarpophalangeal joints of patients without local painful. Sixty RA patients will be selected in the Federal University of São Paulo ambulatory (Unifesp). The patients will be divided in two groups of thirty patients each: "painless synovitis" Group and "painful synovitis" Group. All patients will be measured through clinical evaluation, hands ultrasound and laboratory parameters (erythrocyte sedimentation rate, ESR; rheumatoid factor, RF; anti-cyclic-citrullinated peptide antibodies, CCP) on the same day. The clinical evaluation will be measured by a trained rheumatologist with experience in joint physical examination (synovitis). This measure will be done before the sonography examination and the assessment tools will be: painful joint count; swollen joint count; painful visual analogue scale (VAS 0-10); swollen VAS; activity disease VAS; measurement of grip strength and pinch with Jamar dynamometer and Preston Pinch Gauge; 28 joint Disease Activity Score (DAS 28); Stanford Health Assessment Questionnaire (HAQ); Cochin Hand Functional Scale (CHFS) and patient clinical evaluation. The level of statistical significance will be 5%.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Federal University of São Paulo ambulatory (Unifesp) and basic helth unit

Criteria

Inclusion Criteria:

  • longstanding rheumatoid arthritis
  • chronically painless synovitis in the hands or painful

Exclusion Criteria:

  • uncompensated systemic disease, e.g. diabetes mellitus, hypothyroidism
  • change of basic drug in the last 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01639287

Contacts
Contact: Daniele F Pereira +55 11 96088607 danisfreits22@yahoo.com.br

Locations
Brazil
Universidade Federal de Sao Paulo Recruiting
Sao Paulo, SP, Brazil, 04023900
Contact: Daniele Pereira    55 11 96088707    danisfreitas22@yahoo.com.br   
Sponsors and Collaborators
Federal University of São Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Daniele F Pereira, Dr Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Daniele Freitas Pereira, Dr, Principal Investigator, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01639287     History of Changes
Other Study ID Numbers: USG-3131-AR
Study First Received: July 10, 2012
Last Updated: July 11, 2012
Health Authority: Brazil: Ethics Committee

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

ClinicalTrials.gov processed this record on November 23, 2014