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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
Sponsor:
Information provided by (Responsible Party):
Bryant England, 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 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 UNMC rheumatologic serum and tissue biobank (IRB#292-14-EP), which would allow future use of early RA samples.


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Group/Cohort
No treatment
No treatment



Primary Outcome Measures :
  1. High resolution CT chest results in early RA patients [ Time Frame: 1 year ]
    These will be done at study visit 1.


Secondary Outcome Measures :
  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.

  2. 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.

  3. 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
serum, plasma, whole blood for RNA/DNA isolation


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Ages Eligible for Study:   19 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 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.

Information from the National Library of Medicine

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


Contacts
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Contact: Sherrie Edwards, BSDH 402-559-8140 sherrie.edwards@unmc.edu
Contact: Bart C Hamilton, MPH 402-559-9036 bchamilton@unmc.edu

Locations
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United States, Nebraska
University of Nebraska Medical Center Recruiting
Omaha, Nebraska, United States, 68198-3025
Contact: Sherrie Edwards    402-559-8140    sherrie.edwards@unmc.edu   
Sub-Investigator: Tina Mahajan, MD         
Principal Investigator: Bryant England, MD         
Sponsors and Collaborators
University of Nebraska
Investigators
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Study Chair: Tina D Mahajan, MD University of Nebraska
Principal Investigator: Bryant England, MD University of Nebraska

Additional Information:

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Responsible Party: Bryant England, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT03192267     History of Changes
Other Study ID Numbers: 282-16-FB
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 18, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bryant England, University of Nebraska:
newly diagnosed rheumatoid arthritis
lung disease
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Lung Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases