Early Rheumatoid Arthritis Lung Disease Study
1 other identifier
observational
100
1 country
1
Brief Summary
Extra-articular (outside of joints) disease occurs in approximately 50% of rheumatoid arthritis (RA) patients, with the lung being a common site of involvement. The goals of this study are to investigate and characterize lung disease and its prevalence in early RA participants. This will be done through pulmonary function and high resolution chest computed tomography (CT), questionnaires, and serum studies. Another goal is to find novel biomarkers, such anti-malondialdehyde-acetaldehyde (MAA) antibodies, as predictors of lung disease in RA participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 31, 2017
CompletedStudy Start
First participant enrolled
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2029
August 8, 2025
August 1, 2025
10.9 years
March 31, 2017
August 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
High Resolution Computed Tomography Chest Scan Results
A high resolution computed tomography (CT) chest scan will be done at visit 1 to evaluate the presence of lung disease.
Baseline (Visit 1 only)
Secondary Outcomes (3)
Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Vital Capacity
Baseline and 1 year follow-up
Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Expiratory Volume
Baseline and 1 year follow-up
Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Diffusion Lung Capacity of Carbon Monoxide
Baseline and 1 year follow-up
Study Arms (1)
No treatment
No treatment
Eligibility Criteria
While new onset RA is more likely to occur in young to middle age adults, investigators would also like to study those with more long standing disease. In particular, older RA participants with cardiovascular disease.
You may qualify if:
- years of age
- Able to give informed consent
- Diagnosis of RA by a Rheumatologist using 2010 American College of Rheumatology (ACR) criteria within the past 2 years
You may not qualify if:
- Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA)
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Biospecimen
Serum, plasma, and whole blood for RNA/DNA isolation will be obtained.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tina D Mahajan, MD
University of Nebraska
- PRINCIPAL INVESTIGATOR
Bryant R England, MD
University of Nebraska
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2017
First Posted
June 20, 2017
Study Start
March 31, 2017
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
March 1, 2029
Last Updated
August 8, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share