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Early Rheumatoid Arthritis Lung Disease Study

NCT03192267 · University of Nebraska
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study
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 purpose of this study is to characterize the prevalence and classification of lung disease in participants with newly diagnosed rheumatoid arthritis by prospectively gathering information on lung imaging and function, comorbidities and novel biomarkers, such as anti-malondialdehyde-acetaldehyde (MAA). Specifically, the study would determine whether (MAA) adduct antibody concentrations predict computed tomography (CT) changes consistent with RA-lung involvement and determine whether anti-MAA antibody concentrations predict pulmonary function abnormalities in forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1), and diffusion lung capacity of carbon monoxide (DLCO). An additional goal is to develop a cohort of newly diagnosed RA patients who can be followed long-term through electronic medical record (EMR) surveys, and biobank samples.
Eligibility criteria
Inclusion Criteria: * 19-90 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 Exclusion Criteria: * Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA) * Pregnant
Study design
Enrollment target: 100 participants
Age groups: adult, older_adult
Timeline
Starts: 2017-03-31
Estimated completion: 2029-03
Last updated: 2025-08-08
Primary outcomes
  • High Resolution Computed Tomography Chest Scan Results (Baseline (Visit 1 only))
Sponsor
University of Nebraska · other
Contacts & investigators
ContactAimee B Schreiner, MS · contact · aischreiner@unmc.edu · 402-559-4873
ContactBridget Kramer, RN · contact · bridget.kramer@unmc.edu · 402-559-7288
InvestigatorTina D Mahajan, MD · study_chair, University of Nebraska
InvestigatorBryant R England, MD · principal_investigator, University of Nebraska
All locations (1)
University of Nebraska Medical CenterRecruiting
Omaha, Nebraska, United States
Early Rheumatoid Arthritis Lung Disease Study · TrialPath