Early Rheumatoid Arthritis Lung Disease Study

  • End date
    Dec 27, 2027
  • participants needed
  • sponsor
    University of Nebraska
Updated on 27 October 2022


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.


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

Condition Rheumatoid Arthritis
Clinical Study IdentifierNCT03192267
SponsorUniversity of Nebraska
Last Modified on27 October 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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