Early Rheumatoid Arthritis Lung Disease Study
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT03192267
- Lead Sponsor
- University of Nebraska
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- Inflammatory arthritis that does not meet 2010 American College of Rheumatology (ACR) criteria for rheumatoid arthritis (RA)
- Pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method High Resolution Computed Tomography Chest Scan Results Baseline (Visit 1 only) A high resolution computed tomography (CT) chest scan will be done at visit 1 to evaluate the presence of lung disease.
- Secondary Outcome Measures
Name Time Method Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Vital Capacity Baseline and 1 year follow-up Forced vital capacity (FVC), the total amount of air expelled after a deep breath, will be measured (liters) at baseline and 1-year follow-up. These values will be correlated with anti-malondialdehyde acetaldehyde (anti-MAA) antibodies, a novel biomarker for rheumatoid arthritis (RA).
Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Expiratory Volume Baseline and 1 year follow-up Forced expiratory volume in 1 second (FEV1), the amount of air exhaled in a forced breath, will be measured (liters) at baseline and 1-year follow-up. These values will be correlated with anti-malondialdehyde acetaldehyde (anti-MAA) antibodies, a novel biomarker for rheumatoid arthritis (RA).
Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Diffusion Lung Capacity of Carbon Monoxide Baseline and 1 year follow-up Diffusion lung capacity of carbon monoxide (DLCO), the efficiency of gas exchange in the lungs, will be measured (mL/min/mmHg) at baseline and 1-year follow-up. These values will be correlated with anti-malondialdehyde acetaldehyde (anti-MAA) antibodies, a novel biomarker for rheumatoid arthritis (RA).
Trial Locations
- Locations (1)
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States