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

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

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

Study Overview

• Status: Unknown
• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease
• Intervention / Treatment: Other: ILD

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 Type: Observational
• Enrollment (Anticipated): 600

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 04763
    • Recruiting
    • Hanyang University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Korean patients diagnosed with RA with normal chest CT result within 2 years of clinical visit.

Korean patients diagnosed with RA-ILD with chest CT results indicating ILD within 2 years of clinical visit.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RA-ILD; Patients who are diagnosed with ILD. No intervention in this study.	Other: ILD; This is an observational study without any intervention.
RA-non ILD; Patients who are not diagnosed with ILD. No intervention in this study.	Other: ILD; This is an observational study without any intervention.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hanyang University
• Investigators: Principal Investigator: Yoon-Kyoung Sung, MD,PhD,MPH, Hanyang University Hospital for Rheumatic Diseases

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): March 1, 2022

Study Registration Dates

• First Submitted: January 26, 2017
• First Submitted That Met QC Criteria: March 28, 2017
• First Posted (Actual): April 4, 2017

Study Record Updates

• Last Update Posted (Actual): June 17, 2020
• Last Update Submitted That Met QC Criteria: June 16, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: HUHRD-SPE-16-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No