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

• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease
• Interventions: Other: ILD

• Registration Number: NCT03099525
• Lead Sponsor: Hanyang University

Brief 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

Detailed 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 Timeline

• Study Start: 2016-10
• Study First Submitted: 2017-01-26
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-04-04
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17
• Primary Completion: 2021-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RA-ILD	ILD	Patients who are diagnosed with ILD. No intervention in this study.
RA-non ILD	ILD	Patients who are not diagnosed with ILD. No intervention in this study.

Primary Outcome Measures

Name	Time	Method
Mortality	5 years	Comparison of prognosis such as mortality between RA-ILD and RA-non ILD

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hanyang University; 🇰🇷 Seoul, Korea, Republic of