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

NCT ID: NCT03099525

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-10-31

Study Completion Date

2022-03-31

Brief Summary

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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

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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.

Conditions

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Rheumatoid Arthritis Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RA-ILD

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

ILD

Intervention Type OTHER

This is an observational study without any intervention.

RA-non ILD

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

ILD

Intervention Type OTHER

This is an observational study without any intervention.

Interventions

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ILD

This is an observational study without any intervention.

Intervention Type OTHER

Eligibility Criteria

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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

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Yoon-Kyoung Sung

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoon-Kyoung Sung, MD,PhD,MPH

Role: PRINCIPAL_INVESTIGATOR

Hanyang University Hospital for Rheumatic Diseases

Locations

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Hanyang University

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yoon-Kyoung Sung, MD,PhD,MPH

Role: CONTACT

82-2-2290-9250

Facility Contacts

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Yoon-kyoung Sung, MD, PhD, MPH

Role: primary

82-2-2290-9250

References

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Kim H, Cho SK, Song YJ, Kang J, Jeong SA, Kim HW, Choi CB, Kim TH, Jun JB, Bae SC, Yoo DH, Lee H, Park DW, Sohn JW, Yoon HJ, Hong SJ, Yoo SJ, Choi YW, Lee Y, Kim SH, Sung YK. Clinical characteristics of rheumatoid arthritis patients with interstitial lung disease: baseline data of a single-center prospective cohort. Arthritis Res Ther. 2023 Mar 17;25(1):43. doi: 10.1186/s13075-023-03024-8.

Reference Type DERIVED
PMID: 36932433 (View on PubMed)

Other Identifiers

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HUHRD-SPE-16-08

Identifier Type: -

Identifier Source: org_study_id

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