NCT01641705

Brief Summary

Rheumatoid arthritis (RA) is an autoimmune disease of unknown etiology characterized by peripheral polyarthritis, symmetric, which leads to joint destruction and deformity. It is estimated that the RA reaches about 0.5% of the population. According to data from DATASUS, was responsible for 26,671 hospitalizations, 229 deaths and cost exceeding R$ 20 million in 2005-2007. The main bodily changes are related to joint problems, however, systemic manifestations are also found in organs such as lung and heart. Although cardiovascular diseases are the most responsible of the deaths AR, pulmonary complications are common and account for 10% to 15% of all mortality. Anaya and colleagues point out that the pulmonary involvement contributes significant morbidity and mortality in these patients. Although pulmonary involvement is a frequent manifestation in RA, the prevalence and nature of rheumatoid lung disease has not yet been precisely established. Several lung disorders such as interstitial pulmonary fibrosis, pulmonary nodules and bronchiolitis may ocorrer1. Laitinen et al point out that studies of lung function appear to be a valuable helper for radiography in the evaluation of pulmonary involvement in connective tissue diseases. Previous studies indicate that patients with RA have an increased incidence of abnormal lung function, according to assessments including spirometry, lung volume tests and diffusion capacity of carbon monoxide. Thus, the main objective of this study is to analyze the respiratory mechanics of patients with RA. Specific objectives were to seek to understand whether a relationship exists between duration of rheumatoid disease and lung function in these patients. For this, the investigators used 18 subjects in the control group, free of pulmonary disease and / or heart, all nonsmokers. In the RA group, a total of 72 patients divided into 4 groups of 18 volunteers each, classified according to disease duration (0-5 years, 6-10 years, 11-15 years and\> or = 16 years). It is noteworthy that all patients in the RA group will also be non-smokers, since it is already known in the literature that smoking impairs lung function. All individuals will perform the function test with a trained technician and qualified to function. The examinations will be conducted: Forced oscillation technique and spirometry, in that order.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

July 17, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

2.4 years

First QC Date

March 13, 2012

Last Update Submit

July 16, 2012

Conditions

Keywords

rheumatoid arthritisrespiratory mechanicstime of disease

Study Arms (5)

Control Group

Group of nonsmokers individuals without respiratory disease.

RA patients 1

RA patients nonsmokers with up to five years of disease.

RA group 2

RA patients nonsmokers with six to ten years of disease.

RA group 3

RA patients nonsmokers with eleven to fifteen years of disease.

RA group 4

RA patients nonsmokers with sixteen or more years of disease

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The control group will consist of healthy subjects, nonsmokers, who had no episode of respiratory infection thirty days before the examinations. The group of patients with rheumatoid arthritis will be comprised of individuals treated at the Department of Rheumatology (Hospital Universitártio Pedro Ernesto) nonsmokers, who had no episode of respiratory infection thirty days before the examinations.

You may qualify if:

  • Volunteers with Rheumatoid Arthritis for Patients Group;
  • Volunteers without any respiratory disease for the control group.

You may not qualify if:

  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratório de Instrumentação Biomédica

Rio de Janeiro, Rio de Janeiro, 21550-013, Brazil

RECRUITING

Related Publications (2)

  • Faria AD, Lopes AJ, Jansen JM, Pinheiro GC, Melo PL. Diagnostic performance of the Forced Oscillation Technique in the detection of early respiratory changes in rheumatoid arthritis. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:6034-7. doi: 10.1109/IEMBS.2010.5627605.

  • Faria AC, Barbosa WR, Lopes AJ, Pinheiro Gda R, Melo PL. Contrasting diagnosis performance of forced oscillation and spirometry in patients with rheumatoid arthritis and respiratory symptoms. Clinics (Sao Paulo). 2012 Sep;67(9):987-94. doi: 10.6061/clinics/2012(09)01.

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Pedro L de Melo

    State University of Rio de Janeiro

    STUDY DIRECTOR

Central Study Contacts

Alvaro Camilo D Faria

CONTACT

Study Design

Study Type
observational
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2012

First Posted

July 17, 2012

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

July 1, 2013

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations