Investigate the Development and Progression of Lung Disease in Rheumatoid Arthritis Over Time

Rheumatoid Arthritis Clinical Trial

— RA-LD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03616158
• Other study ID #: HS-3161
• Status: Recruiting
• Start date: May 10, 2018
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2019
• Source: National Jewish Health
• Contact: Faduma Ahmed, MPH
• Phone: 303-398-1285
• Email: ahmedf[@]NJHealth.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 340
• Est. completion date: December 1, 2024
• Est. primary completion date: May 10, 2023
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Lung Diseases
• Rheumatoid Arthritis

Locations

Country	Name	City	State
United States	National Jewish Health	Denver	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
National Jewish Health	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Define which patients with RA (or pre-RA) are at greatest risk for developing RA-related lung disease (LD).		10 years