Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time (RA-LD)

June 5, 2019 updated by: National Jewish Health

Change in Serum and Sputum Biomarkers Over Time in the Development of Rheumatoid Arthritis-associated Lung Disease

The purpose of this study is to investigate the link between the lungs and rheumatoid arthritis (RA). Additionally, to understand why RA patients get lung disease, how to treat, and prevent the disease.

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is to learn more about the risk factors for the development of lung disease among patients with rheumatoid arthritis (RA), an auto-immune disease. Additionally, those at heightened risk of developing RA such as in the pre-RA period. This is a prospective and retrospective study, which 420 patients will be enrolled into the study. In-person participation will be up to 4 years, completing different standard of care assessments yearly. Additionally, quality of life questionnaires will be completed every 6 months at 4 time points. Lastly, an extended follow-up will be performed yearly for an additional 6 years, an overall 10 year participation.

Study Type

Observational

Enrollment (Anticipated)

340

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health
        • Contact:
        • Sub-Investigator:
          • Kristen M Demoruelle, MD
        • Sub-Investigator:
          • Michael Mohning, MD
        • Sub-Investigator:
          • Isabelle Amigues, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects are selected for participation in the study because they are diagnosed with or without rheumatoid arthritis and lung disease.

Description

Inclusion Criteria:

1. Age 18 - 80 years

Exclusion Criteria:

  1. Subjects who do not speak English
  2. Subjects without the capacity to sign the informed consent form (ICF)
  3. Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pre-RA

Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and positive antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

In-person Study Assessments Include:

  1. Medical History and Physical Exams
  2. Quality of Life Questionnaires
  3. Collection of blood
  4. Radiology
  5. Lung Function Test
  6. 6 Minute Walk Test
  7. Bronchoscopy (Clinically indicated)
  8. Sputum (Optional)
  9. Musculoskeletal ultrasound (Optional)
RA without LD

Subjects with rheumatoid arthritis (RA), and no interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

In-person Study Assessments Include:

  1. Medical History and Physical Exams
  2. Quality of Life Questionnaires
  3. Collection of blood
  4. Radiology
  5. Lung Function Test
  6. 6 Minute Walk Test
  7. Bronchoscopy (Clinically indicated)
  8. Sputum (Optional)
  9. Musculoskeletal ultrasound (Optional)
RA-LD

Subjects with rheumatoid arthritis (RA) and interstitial lung disease (ILD) or airways disease, will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

In-person Study Assessments Include:

  1. Medical History and Physical Exams
  2. Quality of Life Questionnaires
  3. Collection of blood
  4. Radiology
  5. Lung Function Test
  6. 6 Minute Walk Test
  7. Bronchoscopy (Clinically indicated)
  8. Sputum (Optional)
  9. Musculoskeletal ultrasound (Optional)
LD Controls

Subjects with interstitial lung disease (ILD) or airways disease, no rheumatoid arthritis (RA), and negative antibodies will participate in 5 in-person study visits. Additionally, quality of life questionnaires will be mailed/emailed and completed at home every 6 months, at 4 different time points. Overall participation will take place over a 4 year time frame and an additional 6 years of survival follow-up.

In-person Study Assessments Include:

  1. Medical History and Physical Exams
  2. Quality of Life Questionnaires
  3. Collection of blood
  4. Radiology
  5. Lung Function Test
  6. 6 Minute Walk Test
  7. Bronchoscopy (Clinically indicated)
  8. Sputum (Optional)
  9. Musculoskeletal ultrasound (Optional)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Jewish Health

Collaborators

Pfizer

Investigators

  • Principal Investigator: Joshua Solomon, MD, National Jewish Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2018

Primary Completion (Anticipated)

May 10, 2023

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

July 31, 2018

First Submitted That Met QC Criteria

August 3, 2018

First Posted (Actual)

August 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 6, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-3161

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe