Early Rheumatoid Arthritis Lung Disease Study

Study Overview
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Brief Summary
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The primary goal of this study is to investigate lung disease, through pulmonary function and high resolution chest CT, in newly diagnosed RA patients. Extra-articular disease occurs in approximately 50% of RA patients, with the lung being a common site of involvement. Investigators goal is to understand the prevalence of lung disease in early RA patients and to better characterize it through questionnaires, imaging, and serum studies. Additionally, the goal is to find novel biomarkers to predict lung disease in RA patients.

Detailed Description
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The purpose of this study is to gather, in a prospective manner, information on patients with newly diagnosed rheumatoid arthritis and their disease course. Specific aims of the study are: To determine whether anti-malondialdehyde-acetaldehyde (MAA) adduct antibody concentrations predict CT changes consistent with RA-lung involvement. To 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) and decline in these parameters at 1 year follow-up. To characterize the prevalence and classification of lung disease in early RA patients. To develop a cohort of newly diagnosed RA patients who can be followed long-term through electronic medical record (EMR) surveys, and biobank samples This study would be the first to look at the correlation of anti-MAA antibody with lung disease. The long-term goal of this study is to create an inception cohort of RA patients that can be followed for many years to come. This would be done through electronic medical records (EMR) and obtaining consent to contact patients in the future if needed. Subjects will be separately consented for UNMC rheumatologic serum and tissue biobank (IRB#292-14-EP), which would allow future use of early RA samples.

Official Title
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Early Rheumatoid Arthritis Lung Disease Study

Conditions
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Rheumatoid Arthritis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients 19-90 years old with the ability to give informed consent. Diagnosis of RA established by a Rheumatologist using the 2010 ACR criteria within the past 2 years. Exclusion Criteria: Patients will be excluded if they have inflammatory arthritis that does not meet 2010 ACR criteria for RA. Patients will be excluded if they are pregnant.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>No treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High resolution CT chest results in early RA patients | These will be done at study visit 1. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine whether anti-MAA antibody concentrations predict abnormalities in forced vital capacity. | Pulmonary function abnormalities in forced vital capacity (FVC measured in Liters) and decline in this parameter at 1 year follow-up. | 1 year | 
| Determine whether anti-MAA antibody concentrations predict abnormalities in forced expiratory volume. | Pulmonary function abnormalities in forced expiratory volume in 1 second (FEV1 measured in Liters) and decline in this parameter at 1 year follow-up. | 1 year | 
| Determine whether anti-MAA antibody concentrations predict abnormalities in diffusion lung capacity of carbon monoxide. | Pulmonary function abnormalities in diffusion lung capacity of carbon monoxide (DLCO measured as mL/min/mmHg) and decline in this parameter at 1 year follow-up. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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newly diagnosed rheumatoid arthritis, lung disease