Treatment Outcome and Prognostic Factors for Rheumatoid Arthritis (RA) Patients With Interstitial Lung Disease (ILD)
1 other identifier
observational
600
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 26, 2017
CompletedFirst Posted
Study publicly available on registry
April 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedJune 17, 2020
June 1, 2020
4.4 years
January 26, 2017
June 16, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality
Comparison of prognosis such as mortality between RA-ILD and RA-non ILD
5 years
Secondary Outcomes (5)
Pulmonary function test
5 years
DAS28(Disease Activity Score in 28 joint)
5 years
SDAI(Simple Disease Activity Index)
5 years
CDAI(Clinic Disease Activity Index)
5 years
Change of DAS28
5 years
Study Arms (2)
RA-ILD
Patients who are diagnosed with ILD. No intervention in this study.
RA-non ILD
Patients who are not diagnosed with ILD. No intervention in this study.
Interventions
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hanyang University
Seoul, 04763, South Korea
Related Publications (1)
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.
PMID: 36932433DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoon-Kyoung Sung, MD,PhD,MPH
Hanyang University Hospital for Rheumatic Diseases
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
January 26, 2017
First Posted
April 4, 2017
Study Start
October 1, 2016
Primary Completion
March 1, 2021
Study Completion
March 1, 2022
Last Updated
June 17, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share