Rheumatoid ArthritisNCT01641705
Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2010to Jul 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Volunteers with Rheumatoid Arthritis for Patients Group;
- Volunteers without any respiratory disease for the control group.
Who cannot join
- Smokers
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Laboratório de Instrumentação Biomédica
Rio de Janeiro, Rio de Janeiro, 21550-013
Alvaro Camilo D Faria, (5521)78201688, acdffisio@gmail.com
Alvaro Camilo D Faria
About this study
Official title: Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis: Effect of Duration of Disease
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.
Read more
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.
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, respiratory mechanics, time of disease
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJul 2010
- Primary completionDec 2012 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Pedro Ernesto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alvaro Camilo Dias Faria, Hospital Universitario Pedro Ernesto
- Investigators
- Pedro L de Melo, Study director, State University of Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641705
- Sponsor's protocol ID
- AR-01
- Status last verified
- Jul 2012
- First submitted
- 13 Mar 2012
- Last updated
- 17 Jul 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21097117Faria 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.
PubMed 23018292
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Respiratory Mechanics in Patients With Rheumatoid Arthritis: Effect of Duration of Disease
- ClinicalTrials.gov ID
- NCT01641705
- Acronym / sponsor ID
- AR-01
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, respiratory mechanics, time of disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Hospital Universitario Pedro ErnestoUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Volunteers with Rheumatoid Arthritis for Patients Group;
- Volunteers without any respiratory disease for the control group.
Key exclusion criteria (1 listed)
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2012.
- Results publication: PubMed 21097117Faria 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.
- Derived from this study: PubMed 23018292Faria 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.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pedro L de Melo study director
State University of Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Hospital Universitario Pedro Ernesto at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Camilo D Faria ((5521)2334-0705, acdffisio@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01641705, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2012.