Rheumatoid ArthritisNCT03099525
Treatment Outcome and Prognostic Factors for Rheumatoid Arthritis (RA) Patients With Interstitial Lung Disease (ILD)
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by Hanyang University at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Interstitial Lung Disease
- What is being tested?
- ILD
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2016to Mar 2022
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University
Seoul, 04763
Yoon-kyoung Sung, MD, PhD, MPH, 82-2-2290-9250, sungyk@hanyang.ac.kr
About this study
Official title: Treatment Outcome and Prognostic Factors for RA Patients With Interstitial Lung Disease
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
Read the detailed description
Primary objective
: Comparison of prognosis between RA-ILD and RA-non ILD patients
Secondary objectives
- Identification of the prognostic factors or aggravation factors of ILD in RA-ILD patients
- Identification of the association between ILD and autoantibody profiles in RA-ILD patients
- 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)
- 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
- Rheumatoid Arthritis, Interstitial Lung Disease
- Being tested
- ILD
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILDOther
This is an observational study without any intervention.
| Study group | Role | What they receive |
|---|---|---|
| RA-ILD | Patients who are diagnosed with ILD. No intervention in this study. Receives: Other: ILD | |
| RA-non ILD | Patients who are not diagnosed with ILD. No intervention in this study. Receives: Other: ILD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Comparison of prognosis such as mortality between RA-ILD and RA-non ILD
Measured: 5 years
Secondary outcomes (5)
Pulmonary function test
Identify aggravation factors for RA-ILD
Measured: 5 years
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)
Measured: 5 years
SDAI(Simple Disease Activity Index)
Comparison of RA disease activity control between RA-ILD and RA-non ILD using Simple Disease Activity Index(SDAI)
Measured: 5 years
CDAI(Clinic Disease Activity Index)
Comparison of RA disease activity control between RA-ILD and RA-non ILD using Clinic Disease Activity Index(CDAI)
Measured: 5 years
Change of DAS28
Comparison of biologic and non-biologic DMARDs treatment response in RA patients
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2017
- Study startOct 2016
- Primary completionMar 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoon-Kyoung Sung, Hanyang University
- Investigators
- Yoon-Kyoung Sung, MD,PhD,MPH, Principal investigator, Hanyang University Hospital for Rheumatic Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03099525
- Sponsor's protocol ID
- HUHRD-SPE-16-08
- Status last verified
- Jun 2020
- First submitted
- 26 Jan 2017
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36932433
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome and Prognostic Factors for RA Patients With Interstitial Lung Disease
- ClinicalTrials.gov ID
- NCT03099525
- Acronym / sponsor ID
- HUHRD-SPE-16-08
- Conditions
- Rheumatoid Arthritis, Interstitial Lung Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 4 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Identification of the prognostic factors or aggravation factors of ILD in RA-ILD patients
- Identification of the association between ILD and autoantibody profiles in RA-ILD patients
- 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)
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RA-ILD | – | Other: ILDPatients who are diagnosed with ILD. No intervention in this study. |
| RA-non ILD | – | Other: ILDPatients who are not diagnosed with ILD. No intervention in this study. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ILDThis is an observational study without any intervention. | Other | RA-ILD, RA-non ILD |
Primary outcome
Mortality
Time frame: 5 years
Comparison of prognosis such as mortality between RA-ILD and RA-non ILD
5 secondary outcomes
Pulmonary function test
Time frame: 5 years
DAS28(Disease Activity Score in 28 joint)
Time frame: 5 years
SDAI(Simple Disease Activity Index)
Time frame: 5 years
CDAI(Clinic Disease Activity Index)
Time frame: 5 years
Change of DAS28
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
- Derived from this study: PubMed 36932433Kim 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-Kyoung Sung, MD,PhD,MPH principal investigator
Hanyang University Hospital for Rheumatic Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yoon-Kyoung Sung, MD,PhD,MPH (82-2-2290-9250, sungyk@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03099525, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2020.