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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	19 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03099525
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Hanyang University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yoon-Kyoung Sung, MD,PhD,MPH
Principal Investigator Affiliation	Hanyang University Hospital for Rheumatic Diseases
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	Korea, Republic of
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis, Interstitial Lung Disease

Additional Details

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.

Arms & Interventions

Arms

: 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

Other: - ILD

This is an observational study without any intervention.

Contact a Trial Team

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