Clinical trial NCT03192267: Early Rheumatoid Arthritis Lung Disease Study
Official title: Early Rheumatoid Arthritis Lung Disease Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis
Keywords: newly diagnosed rheumatoid arthritis
lung disease
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 100
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: While new onset RA is more likely to occur in young to middle age adults, investigators would also like to study those with more long standing disease. In particular, older RA participants with cardiovascular disease.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: High Resolution Computed Tomography Chest Scan Results
timeFrame: Baseline (Visit 1 only)
Secondary outcomes:
measure: Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Vital Capacity
timeFrame: Baseline and 1 year follow-up
measure: Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Forced Expiratory Volume
timeFrame: Baseline and 1 year follow-up
measure: Anti-malondialdehyde acetaldehyde Antibody Concentrations as Abnormality Predictors in Diffusion Lung Capacity of Carbon Monoxide
timeFrame: Baseline and 1 year follow-up
Other outcomes:
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Tina D Mahajan, MD
role: STUDY_CHAIR
affiliation: University of Nebraska
name: Bryant R England, MD
role: PRINCIPAL_INVESTIGATOR
References: