Pulmonary FibrosisNCT00001876
Lung Disease Associated With Rheumatoid Arthritis
An observational study of Pulmonary Fibrosis, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pulmonary Fibrosis
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 1999to 11 Dec 2007
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects will include individuals with (1) rheumatoid arthritis and biopsy-proven pulmonary fibrosis, (2) rheumatoid arthritis-only, and (3) biopsy-proven idiopathic pulmonary fibrosis-only.@@@
Who may be able to join
- Non-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of age or older with any of the following:
- Rheumatoid arthritis with biopsy-proven pulmonary fibrosis or;
- Rheumatoid arthritis only, or;
- Biopsy-proven idiopathic pulmonary fibrosis.
Who cannot join
- Forced expiratory volume in one second (FEV1) less than 1L.
- Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).
- Chronic cardiopulmonary disorders other than pulmonary fibrosis.
- Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).
- Non-rheumatoid arthritis.
- Viral infections associated with pulmonary fibrosis (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).
- Uncorrectable bleeding diathesis.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease
Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.
Patients participating in this study will undergo a series of tests and examinations before and throughout the study. The tests include blood and urine tests, electrical measures of heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests, exercise tests, and fiberoptic bronchoscopy.
Read more
The goals of this study are to:
- Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,
- Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,
- Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and
- Learn more about the factors that contribute to the development or progression fibrotic lung disease....
Read the detailed description
Pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology remains uncertain. Although the clinical course of many individuals with this disorder can mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. It is the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic, radiologic, and biochemical markers that predict the development or progression of fibrotic lung disease.
- Conditions
- Pulmonary Fibrosis
- Keywords
- Interstitial Lung Disease, Collagen Vascular Disease, Extracellular Matrix, Pulmonary Function, DTPA Lung Clearance Scan, Natural History
- Medical subject headings
- Pulmonary Fibrosis, Lung Diseases, Interstitial, Collagen Diseases
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 |
|---|---|---|
| Combo | Patients with rheumatoid arthritis and biopsy-proven pulmonary fibrosis. | |
| pulmonary fibrosis | Patients with biobsy-proven idiopathic pulmonary fibrosis only. | |
| rheumatoid arthritis | Patients with rheumatoid arthritis only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence
To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.
Measured: Ongoing
Natural History
To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start5 Apr 1999
- Primary completion9 Nov 2005
- Study completion11 Dec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary FibrosisStudies 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Bernadette R Gochuico, M.D., Principal investigator, National Human Genome Research Institute (NHGRI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001876
- Sponsor's protocol ID
- 990056
- Other IDs
- 99-HG-0056
- Status last verified
- Sep 2022
- First submitted
- 3 Nov 1999
- Last updated
- 29 Sep 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease
- ClinicalTrials.gov ID
- NCT00001876
- Acronym / sponsor ID
- 990056
- Conditions
- Pulmonary Fibrosis
- Keywords
- Interstitial Lung Disease, Collagen Vascular Disease, Extracellular Matrix, Pulmonary Function, DTPA Lung Clearance Scan, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 5 Apr 1999 (actual)
- Primary completion
- 9 Nov 2005 (actual)
- Study completion
- 11 Dec 2007 (actual)
- First posted
- 4 Nov 1999 (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.
Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.
Patients participating in this study will undergo a series of tests and examinations before and throughout the study. The tests include blood and urine tests, electrical measures of heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests, exercise tests, and fiberoptic bronchoscopy.
The goals of this study are to:
- Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis,
- Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis,
- Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and
- Learn more about the factors that contribute to the development or progression fibrotic lung disease....
Detailed description
Pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology remains uncertain. Although the clinical course of many individuals with this disorder can mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. It is the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic, radiologic, and biochemical markers that predict the development or progression of fibrotic lung disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Combo | – | –Patients with rheumatoid arthritis and biopsy-proven pulmonary fibrosis. |
| pulmonary fibrosis | – | –Patients with biobsy-proven idiopathic pulmonary fibrosis only. |
| rheumatoid arthritis | – | –Patients with rheumatoid arthritis only. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will include individuals with (1) rheumatoid arthritis and biopsy-proven pulmonary fibrosis, (2) rheumatoid arthritis-only, and (3) biopsy-proven idiopathic pulmonary fibrosis-only.@@@
Key inclusion criteria (4 listed)
- Non-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of age or older with any of the following:
- Rheumatoid arthritis with biopsy-proven pulmonary fibrosis or;
- Rheumatoid arthritis only, or;
- Biopsy-proven idiopathic pulmonary fibrosis.
Key exclusion criteria (8 listed)
- Forced expiratory volume in one second (FEV1) less than 1L.
- Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).
- Chronic cardiopulmonary disorders other than pulmonary fibrosis.
- Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).
- Non-rheumatoid arthritis.
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
Prevalence
Time frame: Ongoing
To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.
Natural History
Time frame: Ongoing
To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Bernadette R Gochuico, M.D. principal investigator
National Human Genome Research Institute (NHGRI)
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 Pulmonary Fibrosis, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 29 Sep 2022. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence (time frame: Ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Sep 2022.