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Early Rheumatoid Arthritis Lung Disease Study

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University of Nebraska

Status

Enrolling

Conditions

Rheumatoid Arthritis

Study type

Observational

Funder types

Other

Identifiers

NCT03192267
0282-16-FB

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

19 to 90 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

No treatment
Description:
No treatment

Trial contacts and locations

1

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Central trial contact

Bridget Kramer, RN; Aimee B Schreiner, MS

Data sourced from clinicaltrials.gov

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