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

NCT ID: NCT01685905

Last Updated: 2012-09-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-04-30

Study Completion Date

2013-09-30

Brief Summary

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The purposes of this study

1. 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
2. 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

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Study Assessment

1. 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
2. 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
3. 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).

Conditions

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Rheumatic Disease Rheumatoid Arthritis Ankylosing Spondylitis Tuberculosis

Keywords

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rheumatic disease, latent tuberculosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role lead

Responsible Party

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Sang-Cheol Bae

Professor, MD, PhD, MPH

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sang-cheol Bae, director

Role: PRINCIPAL_INVESTIGATOR

Hanyang University Hospital for Rheumatic Disease

Locations

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Hanyang University Hospital for rheumatic disease

Seoul, Sung-dong Gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Sang-cheol Bae, director

Role: CONTACT

Phone: 82-2-2290-8260

Email: [email protected]

Facility Contacts

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Sang-cheol Bae, MD

Role: primary

Other Identifiers

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TST_IGRA

Identifier Type: -

Identifier Source: org_study_id