Early Rheumatoid Arthritis Lung Disease Study
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|ClinicalTrials.gov Identifier: NCT03192267|
Recruitment Status : Recruiting
First Posted : June 20, 2017
Last Update Posted : June 18, 2019
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.
|Condition or disease|
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:
- To determine whether anti-malondialdehyde-acetaldehyde (MAA) adduct antibody concentrations predict CT changes consistent with RA-lung involvement.
- 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.
- To characterize the prevalence and classification of lung disease in early RA patients.
- 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 [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Early Rheumatoid Arthritis Lung Disease Study|
|Actual Study Start Date :||May 2, 2017|
|Estimated Primary Completion Date :||October 2026|
|Estimated Study Completion Date :||November 2027|
- High resolution CT chest results in early RA patients [ Time Frame: 1 year ]These will be done at study visit 1.
- Determine whether anti-MAA antibody concentrations predict abnormalities in forced vital capacity. [ Time Frame: 1 year ]Pulmonary function abnormalities in forced vital capacity (FVC measured in Liters) and decline in this parameter at 1 year follow-up.
- Determine whether anti-MAA antibody concentrations predict abnormalities in forced expiratory volume. [ Time Frame: 1 year ]Pulmonary function abnormalities in forced expiratory volume in 1 second (FEV1 measured in Liters) and decline in this parameter at 1 year follow-up.
- Determine whether anti-MAA antibody concentrations predict abnormalities in diffusion lung capacity of carbon monoxide. [ Time Frame: 1 year ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03192267
|Contact: Sherrie Edwards, BSDHfirstname.lastname@example.org|
|Contact: Bart C Hamilton, MPHemail@example.com|
|United States, Nebraska|
|University of Nebraska Medical Center||Recruiting|
|Omaha, Nebraska, United States, 68198-3025|
|Contact: Sherrie Edwards 402-559-8140 firstname.lastname@example.org|
|Sub-Investigator: Tina Mahajan, MD|
|Principal Investigator: Bryant England, MD|
|Study Chair:||Tina D Mahajan, MD||University of Nebraska|
|Principal Investigator:||Bryant England, MD||University of Nebraska|