Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Rheumatoid Arthritis Lung Disease Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date March 31, 2017
First Posted Date June 20, 2017
Last Update Posted Date June 18, 2019
Actual Study Start Date May 2, 2017
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 16, 2017)
High resolution CT chest results in early RA patients [ Time Frame: 1 year ]
These will be done at study visit 1.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03192267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 4, 2019)
  • 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.
Original Secondary Outcome Measures
 (submitted: June 16, 2017)
Determine whether anti-MAA antibody concentrations predict pulmonary function abnormalities [ Time Frame: 1 year ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early Rheumatoid Arthritis Lung Disease Study
Official Title Early Rheumatoid Arthritis Lung Disease Study
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.

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 [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Description:
serum, plasma, whole blood for RNA/DNA isolation
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.
Condition Rheumatoid Arthritis
Intervention Not Provided
Study Groups/Cohorts No treatment
No treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 16, 2017)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date November 2027
Estimated Primary Completion Date October 2026   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Sherrie Edwards, BSDH 402-559-8140 sherrie.edwards@unmc.edu
Contact: Bart C Hamilton, MPH 402-559-9036 bchamilton@unmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03192267
Other Study ID Numbers 282-16-FB
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Bryant England, University of Nebraska
Study Sponsor University of Nebraska
Collaborators Not Provided
Investigators
Study Chair: Tina D Mahajan, MD University of Nebraska
Principal Investigator: Bryant England, MD University of Nebraska
PRS Account University of Nebraska
Verification Date June 2019