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

Hanyang University

Status: Unknown

Conditions: Interstitial Lung Disease; Rheumatoid Arthritis

Treatments: Other: ILD

Study type: Observational

Funder types: Other

Identifiers

NCT03099525

HUHRD-SPE-16-08

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

600 participants in 2 patient groups

RA-ILD

Description:

Patients who are diagnosed with ILD. No intervention in this study.

Treatment:

Other: ILD

RA-non ILD

Description:

Patients who are not diagnosed with ILD. No intervention in this study.

Treatment:

Other: ILD