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Clinical Trial Summary

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


Clinical Trial Description

Primary objective

: Comparison of prognosis between RA-ILD and RA-non ILD patients

Secondary objectives

1. Identification of the prognostic factors or aggravation factors of ILD in RA-ILD patients

2. Identification of the association between ILD and autoantibody profiles in RA-ILD patients

3. 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)

4. 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03099525
Study type Observational [Patient Registry]
Source Hanyang University
Contact Yoon-Kyoung Sung, MD,PhD,MPH
Phone 82-2-2290-9250
Email sungyk@hanyang.ac.kr
Status Recruiting
Phase
Start date October 2016
Completion date March 2022

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