Interstitial Lung Disease in Early Rheumatoid Arthritis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Interstitial Lung Disease in Early Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis, Interstitial Lung Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 90 years 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) Able to read, speak, and understand English 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: Subjects who do not meet all inclusion criteria Pregnant women

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA with no ILD<br>Subjects diagnosed with RA less then 2 years and without a diagnosis of ILD, will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months. Study Assessments Include: Medical history and Physical exams Quality of Life Questionnaires Collection of Sputum and Blood Radiology (HRCT) Lung Function Test | |
| RA with ILD<br>Patients diagnosed with RA less than 2 years, and clinically diagnosed with interstitial lung disease (ILD), will complete 5 in-person study visits. Visits will be performed every 6 months for 18 months. Study Assessments Include: Medical history and Physical exams Quality of Life Questionnaires Collection of Sputum and Blood Radiology (HRCT) Lung Function Test Spirometry | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Interstitial Lung Disease, ILD, Pulmonary Fibrosis, Rheumatoid Arthritis, RA, Rheumatology