Early Rheumatoid Arthritis Lung Disease Study

Rheumatoid Arthritis Clinical Trial

Official title: Early Rheumatoid Arthritis Lung Disease Study

Status Recruiting

Clinical Trial Summary

The primary goal of this study is to investigate lung disease, through pulmonary function and high resolution chest CT, in newly diagnosed rheumatoid arthritis (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.

Clinical Trial Description

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:

1. To determine whether anti-malondialdehyde-acetaldehyde (MAA) adduct antibody concentrations predict CT changes consistent with RA-lung involvement.

2. 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.

3. To characterize the prevalence and classification of lung disease in early RA patients.

4. 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 rheumatologic serum and tissue biobank (IRB#292-14-EP), which would allow future use of early RA samples. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lung Diseases
• Rheumatoid Arthritis

• NCT number: NCT03192267
• Study type: Observational [Patient Registry]
• Source: University of Nebraska
• Contact: Aimee B Schreiner, MS
• Phone: 402-559-4873
• Email: aischreiner@unmc.edu
• Status: Recruiting
• Start date: February 1, 2017
• Completion date: December 2027