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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03099525
• Other study ID #: HUHRD-SPE-16-08
• Status: Recruiting
• Start date: October 2016
• Est. completion date: March 2022

Study information

• Verified date: June 2020
• Source: Hanyang University
• Contact: Yoon-Kyoung Sung, MD,PhD,MPH
• Phone: 82-2-2290-9250
• Email: sungyk[@]hanyang.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: March 2022
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Intervention

Other:
• ILD
This is an observational study without any intervention.

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Comparison of prognosis such as mortality between RA-ILD and RA-non ILD	5 years
Secondary	Pulmonary function test	Identify aggravation factors for RA-ILD	5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Change of DAS28	Comparison of biologic and non-biologic DMARDs treatment response in RA patients	5 years