Interstitial Lung Disease in Early Rheumatoid Arthritis

• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

• Registration Number: NCT03977415
• Lead Sponsor: National Jewish Health

Brief Summary

The purpose of this study is to determine how interstitial lung disease can be predicted over time in early rheumatoid arthritis. The investigators will study blood and phlegm samples from participants, along with quality of life questionnaires to determine if and how the presence of ILD may impact the participants quality of life over time.

Detailed Description

Participation involves 5 study visits over an 18 month timeframe. During each of these visits, a recent medical history and physical exam will take place, blood and phlegm will be collected, quality of life questionnaires will be administered, and a CT-scan of the chest and pulmonary function testing may be performed.

Study Timeline

• Study Start: 2018-03-27
• Study First Submitted: 2018-07-26
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-05
• Last Update Submitted: 2019-06-05
• Study First Posted: 2019-06-06
• Last Update Posted: 2019-06-06
• Primary Completion: 2020-02-01
• Study Completion: 2021-08-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 76

Inclusion Criteria

1. Age 18 - 90 years
2. Diagnosis of "early RA" with or without ILD as defined by ACR/EULAR 2010 criteria and confirmed by a member of the ILD or Rheumatology programs at National Jewish Health (NJH)
3. Able to read, speak, and understand English
4. Able and willing to perform all study related tasks, including returning to NJH every 6 months for an 18 month period of time

Exclusion Criteria

1. Subjects who do not meet all inclusion criteria
2. Pregnant women

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change from baseline for Multi-Dimensional Health Assessment questionnaire (MDHAQ)	18 months
Change from baseline for Leicester Cough questionnaire-Acute (LCQ_Acute)	18 months
Change in lung antigen targets in RA-ILD using induced sputum	18 months
Change from baseline for UCSD Medical Center Pulmonary Rehabilitations Program Shortness-of-Breath questionnaire	18 months
Change in anti-CCP antibody test to identify the presence or development of RA in patients with or without ILD	18 months
Change from baseline for Short Form (SF_36) questionnaire	18 months

Trial Locations

Locations (1)

National Jewish Health; 🇺🇸 Denver, Colorado, United States