Treatment Outcome and Prognostic Factors for Rheumatoid A... | NCT03099525

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

NCT03099525

Sponsor

Hanyang University

Status

Unknown status

Last Update Posted

Jun 17, 2020Actual

Enrollment

600Estimated

Phase

Not provided

Conditions

Rheumatoid Arthritis
Interstitial Lung Disease

Interventions

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016Actual

Primary Completion Date

Mar 2021Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Jan 26, 2017

First Submission Date that Met QC Criteria

Mar 28, 2017

First Posted Date

Apr 4, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2020

Last Update Posted Date

Jun 17, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RA-ILD		Patients who are diagnosed with ILD. No intervention in this study.	Other: ILD
RA-non ILD		Patients who are not diagnosed with ILD. No intervention in this study.	Other: ILD

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ILD	Other	This is an observational study without any intervention.	RA-ILD RA-non ILD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Comparison of prognosis such as mortality between RA-ILD and RA-non ILD	5 years

Secondary Outcomes

Measure	Description	Time Frame
Pulmonary function test	Identify aggravation factors for RA-ILD	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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoon-Kyoung Sung, MD,PhD,MPH	Contact	82-2-2290-9250		sungyk@hanyang.ac.kr

Overall Officials

Name	Affiliation	Role
Yoon-Kyoung Sung, MD,PhD,MPH	Hanyang University Hospital for Rheumatic Diseases	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University	Recruiting	Seoul		04763	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36932433	Derived	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.

ID	Term
D001172	Arthritis, Rheumatoid
D017563	Lung Diseases, Interstitial

ID	Term
D001168	Arthritis
D007592	Joint Diseases
D009140	Musculoskeletal Diseases
D012216	Rheumatic Diseases