Thinking of joining a study?

Register your interest

NCT03192267 | RECRUITING | Rheumatoid Arthritis


Early Rheumatoid Arthritis Lung Disease Study
Sponsor:

University of Nebraska

Brief 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.

Condition or disease

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

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Early Rheumatoid Arthritis Lung Disease Study
Actual Study Start Date : 2017-03-31
Estimated Primary Completion Date : 2028-03
Estimated Study Completion Date : 2029-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 19 Years to 90 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.

Early Rheumatoid Arthritis Lung Disease Study

Location Details

NCT03192267


Please Choose a site



How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, Nebraska

University of Nebraska Medical Center

Omaha, Nebraska, United States, 68198

Loading...