Clinical trial NCT03099525: Treatment Outcome and Prognostic Factors for Rheumatoid Arthritis (RA) Patients With Interstitial Lung Disease (ILD)
Official title: Treatment Outcome and Prognostic Factors for RA Patients With Interstitial Lung Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Arthritis
Interstitial Lung Disease
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 600
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: 5 years
Secondary outcomes:
measure: Pulmonary function test
timeFrame: 5 years
measure: DAS28(Disease Activity Score in 28 joint)
timeFrame: 5 years
measure: SDAI(Simple Disease Activity Index)
timeFrame: 5 years
measure: CDAI(Clinic Disease Activity Index)
timeFrame: 5 years
measure: Change of DAS28
timeFrame: 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
affiliation: Hanyang University Hospital for Rheumatic Diseases
name: Yoon-Kyoung Sung, MD,PhD,MPH
role: PRINCIPAL_INVESTIGATOR
References: