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NCT Number: NCT03192267

Early Rheumatoid Arthritis Lung Disease Study

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Lung Diseases Musculoskeletal Diseases Respiratory Tract Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

19 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

Location status: Recruiting

Location contact

Bridget Kramer, RN

CONTACT

[email protected]

402-559-4510

Bryant R England, MD

PRINCIPAL_INVESTIGATOR

Tina A Mahajan, MD

SUB_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. High Resolution Computed Tomography Chest Scan Results

    Time frame: 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 outcomes

  1. Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Vital Capacity

    Time frame: 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).

  2. Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Expiratory Volume

    Time frame: 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).

  3. Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Diffusion Lung Capacity of Carbon Monoxide

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Aimee B Schreiner, MS

CONTACT

[email protected]

402-559-4873

Bridget Kramer, RN

CONTACT

[email protected]

402-559-7288

Sponsors and collaborators

Lead sponsor

University of Nebraska

Other

Registry information

Important dates

Study start
2017
Primary completion
2029
Study completion
2030
First posted
Jun 20, 2017
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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