The Usefulness of Interferon-γ Release Assays and Tubercu... | NCT01685905

Studies
The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection

NCT01685905

Sponsor

Hanyang University

Status

Unknown status

Last Update Posted

Sep 18, 2012Estimated

Enrollment

2,000Estimated

Phase

Not provided

Conditions

Rheumatic Disease
Rheumatoid Arthritis
Ankylosing Spondylitis
Tuberculosis

Interventions

Not provided

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

Sep 2012

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

Apr 2012

Primary Completion Date

Sep 2013Estimated

Completion Date

Sep 2013Estimated

First Submitted Date

Sep 12, 2012

First Submission Date that Met QC Criteria

Sep 12, 2012

First Posted Date

Sep 14, 2012Estimated

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

Sep 17, 2012

Last Update Posted Date

Sep 18, 2012Estimated

Name	Class
Bristol-Myers Squibb	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purposes of this study

to compare the positivity of tuberculin skin test(TST) and QuantiFERON-TB Gold (QFT-G), and determine the level of agreement between two tests in patients with rheumatic diseases
to evaluate the difference in the occurrence of active TB in patients who receive both QFT-G and TST compared with those who receive only TST for detecting of Latent tuberculosis infection(LTBI) who are candidates of TNF inhibitors.

Detailed Description

Study Assessment

The positive rates of QFT-G and TST as a screening test for LTBI
- The positive rates of QFT-G and TST will be analyzed
- Additional analysis will be performed according to the type of disease
The agreement between QFT-G and TST as a screening test for LTBI
- The agreement between QFT-G and TST will be analyzed for patients with rheumatic diseases who examined both QFT-G and TST
- Additional analysis will be performed according to the type of disease
The correlation of the occurrence of active TB and two tests (QFT-G and TST)
- The analysis of the correlation of the occurrence of active TB and two tests will be conducted for patients who have experienced anti-TNF agents

3-1. The occurrence of active TB in accordance with results of TST

3-2. The occurrence of active TB in accordance with results of QFT-G

3-3. The difference in the occurrence of active TB in patients performed both QFT-G and TST compared with those performed only TST for detecting of LTBI who are candidates of TNF inhibitors (pilot study).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)		one year

Secondary Outcomes

Measure	Description	Time Frame
The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))		one year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

1) Estimation of the positive rates and agreement between QFT-G and TST

Approximately 2,000 patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010 2) Determining the difference in the occurrence of active TB in the TNF inhibitor user according to the screening and the treatment of LTBI.
Approximately 400 patients with rheumatic diseases who received TST or QFT-G before using anti-TNF agents in Hanyang university hospital from 2004 to 2010

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang-cheol Bae, director	Contact	82-2-2290-8260		scbae@hanyang.ac.kr

Overall Officials

Name	Affiliation	Role
Sang-cheol Bae, director	Hanyang University Hospital for Rheumatic Disease	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University Hospital for rheumatic disease	Recruiting	Seoul	Sung-dong Gu	133-792	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D012216	Rheumatic Diseases
D001172	Arthritis, Rheumatoid
D013167	Spondylitis, Ankylosing
D014376	Tuberculosis
D055985	Latent Tuberculosis

Ancestor Terms

ID	Term
D009140	Musculoskeletal Diseases
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D001168	Arthritis

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Browse Branches

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