Treatment Outcome and Prognostic Factors for Rheumatoid Arthritis (RA) Patients With Interstitial Lung Disease (ILD)

Study Overview
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Brief Summary
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The objectives of this single center, prospective, non-interventional cohort is to understand patient characteristics, general treatment patterns, effectiveness/safety of conventional disease modifying antirheumatic drug (DMARD) and biologic DMARD treatments in rheumatoid arthritis patients with ILD in the real-world setting

Detailed Description
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Primary objective : Comparison of prognosis between RA-ILD and RA-non ILD patients Secondary objectives Identification of the prognostic factors or aggravation factors of ILD in RA-ILD patients Identification of the association between ILD and autoantibody profiles in RA-ILD patients Comparison of RA disease activity control between RA-ILD and RA-non ILD patients using disease activity score (DAS)28-erythrocyte sedimentation ratio (ESR), DAS28 C-reactive protein (CRP), simple disease activity index (SDAI) and clinical disease activity index (CDAI) Comparison of biologic and non-biologic DMARD treatment response in RA-ILD patients using disease activity parameters The study population will be adult RA patients who have checked a chest computed tomography (CT) scan within 2 years of enrollment. No additional visits or laboratory tests will be done outside the routine clinical practice for RA-non ILD patients. For RA-ILD patients, high resolution computed tomography (HRCT), pulmonary function test (PFT) and 6-min walk test will be examined annually to identify the progression of ILD. Selection of medication including conventional DMARDs, biologic DMARDs, glucocorticoid, and inhaler, dosing and treatment duration are at the discretion of the investigator.

Official Title
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Treatment Outcome and Prognostic Factors for RA Patients With Interstitial Lung Disease

Conditions
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Rheumatoid Arthritis, Interstitial Lung Disease

Intervention / Treatment
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* Other: ILD


Participation Criteria
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Eligibility Criteria
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A. Inclusion Criteria: Patients who satisfy the 1987 American college of rheumatology (ACR) or 2010 ACR/EULAR classification criteria for RA adult patients Patients who are more than 19 years old Patients who have checked chest CT scanning within 2 years Patients who provide a written consent of participating in this study B. Exclusion Criteria: Patients who are aged under 19 years old Patients who are pregnant Patients who dose not provide a written consent of participating in this study

Ages Eligible for Study
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Minimum Age: 19 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-ILD<br>Patients who are diagnosed with ILD. No intervention in this study. | Other: ILD<br>* This is an observational study without any intervention.<br>|
| RA-non ILD<br>Patients who are not diagnosed with ILD. No intervention in this study. | Other: ILD<br>* This is an observational study without any intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Comparison of prognosis such as mortality between RA-ILD and RA-non ILD | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function test | Identify aggravation factors for RA-ILD | 5 years | 
| DAS28(Disease Activity Score in 28 joint) | Comparison of RA disease activity control between RA-ILD and RA-non ILD using Disease Activity Score(DAS28) | 5 years | 
| SDAI(Simple Disease Activity Index) | Comparison of RA disease activity control between RA-ILD and RA-non ILD using Simple Disease Activity Index(SDAI) | 5 years | 
| CDAI(Clinic Disease Activity Index) | Comparison of RA disease activity control between RA-ILD and RA-non ILD using Clinic Disease Activity Index(CDAI) | 5 years | 
| Change of DAS28 | Comparison of biologic and non-biologic DMARDs treatment response in RA patients | 5 years |