Early Rheumatoid Arthritis Lung Disease Study

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis

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

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Bart C Hamilton, MPH; Phone Number: 402-559-9036; Email: bchamilton@unmc.edu
• Study Contact Backup: Name: Aimee B Schreiner, MS; Phone Number: 402-559-4873; Email: aischreiner@unmc.edu

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: Aimee B Schreiner, MS; Phone Number: 402-559-4873; Email: aischreiner@unmc.edu
      • Sub-Investigator: Tina A Mahajan, MD
      • Principal Investigator: Bryant R England, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The project is designed to study adult rheumatoid arthritis patients. While new onset RA is more likely to occur in young to middle age adults, we would also like to study those patients with more long standing disease. In particular, older RA patients with cardiovascular disease are of interest. Therefore, we are including a wide age range.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
High resolution CT chest results in early RA patients	These will be done at study visit 1.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Study Chair: Tina D Mahajan, MD, University of Nebraska; Principal Investigator: Bryant R England, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: June 16, 2017
• First Posted (Actual): June 20, 2017

Study Record Updates

• Last Update Posted (Actual): October 3, 2023
• Last Update Submitted That Met QC Criteria: September 29, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: lung disease; newly diagnosed rheumatoid arthritis
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lung Diseases
• Other Study ID Numbers: 0282-16-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No