Early Rheumatoid Arthritis Lung Disease Study

Rheumatoid Arthritis Clinical Trial

Official title:

Early Rheumatoid Arthritis Lung Disease Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03192267
• Other study ID #: 0282-16-FB
• Status: Recruiting
• Start date: February 1, 2017
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: University of Nebraska
• Contact: Aimee B Schreiner, MS
• Phone: 402-559-4873
• Email: aischreiner[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 90 Years

Eligibility

Inclusion Criteria:

• Patients 19-90 years old with the ability to give informed consent.

• Diagnosis of RA established by a Rheumatologist using the 2010 American College of Rheumatology 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.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	High resolution CT chest results in early RA patients	These will be done at study visit 1.	1 year
Secondary	Determine whether anti-MAA antibody concentrations predict abnormalities in forced vital capacity.	Pulmonary function abnormalities in forced vital capacity (FVC measured in Liters) and decline in this parameter at 1 year follow-up.	1 year
Secondary	Determine whether anti-MAA antibody concentrations predict abnormalities in forced expiratory volume.	Pulmonary function abnormalities in forced expiratory volume in 1 second (FEV1 measured in Liters) and decline in this parameter at 1 year follow-up.	1 year
Secondary	Determine whether anti-MAA antibody concentrations predict abnormalities in diffusion lung capacity of carbon monoxide.	Pulmonary function abnormalities in diffusion lung capacity of carbon monoxide (DLCO measured as mL/min/mmHg) and decline in this parameter at 1 year follow-up.	1 year