Clinical trial NCT01685905: The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatic Disease
Rheumatoid Arthritis
Ankylosing Spondylitis
Tuberculosis
Keywords: rheumatic disease, latent tuberculosis
Lead sponsor: Hanyang University
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2012-09-14
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

Detailed 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).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)
timeFrame: one year
Secondary outcomes:
measure: The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))
timeFrame: one year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University Hospital for rheumatic disease
state: Sung-dong Gu
Study officials:
affiliation: Hanyang University Hospital for Rheumatic Disease
name: Sang-cheol Bae, director
role: PRINCIPAL_INVESTIGATOR
References: