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

Rheumatoid Arthritis Clinical Trial

Official title:

Evaluation of the Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Mycobacterium Tuberculosis Infection in Korean Patients With Rheumatic Diseases

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01685905
• Other study ID #: TST_IGRA
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2012
• Last updated: September 17, 2012
• Start date: April 2012
• Est. completion date: September 2013

Study information

• Verified date: September 2012
• Source: Hanyang University
• Contact: Sang-cheol Bae, director
• Phone: 82-2-2290-8260
• Email: scbae[@]hanyang.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Ankylosing Spondylitis
• Arthritis, Rheumatoid
• Latent Tuberculosis
• Rheumatic Disease
• Rheumatic Diseases
• Rheumatoid Arthritis
• Spondylitis
• Spondylitis, Ankylosing
• Tuberculosis

Locations

Country	Name	City	State
Korea, Republic of	Hanyang University Hospital for rheumatic disease	Seoul	Sung-dong Gu

Sponsors (2)

Lead Sponsor	Collaborator
Hanyang University	Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)		one year	No
Secondary	The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))		one year	No