Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Hanyang University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Sang-Cheol Bae, Hanyang University
ClinicalTrials.gov Identifier:
NCT01685905
First received: September 12, 2012
Last updated: September 17, 2012
Last verified: September 2012
  Purpose

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.

Condition
Rheumatic Disease
Rheumatoid Arthritis
Ankylosing Spondylitis
Tuberculosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Hanyang University:

Primary Outcome Measures:
  • The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI) [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST)) [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: April 2012
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685905

Contacts
Contact: Sang-cheol Bae, director 82-2-2290-8260 scbae@hanyang.ac.kr

Locations
Korea, Republic of
Hanyang University Hospital for rheumatic disease Recruiting
Seoul, Sung-dong Gu, Korea, Republic of, 133-792
Contact: Sang-cheol Bae, MD    82-2-2290-9230    scbae@hanyang.ac.kr   
Sponsors and Collaborators
Hanyang University
Bristol-Myers Squibb
Investigators
Principal Investigator: Sang-cheol Bae, director Hanyang University Hospital for Rheumatic Disease
  More Information

No publications provided

Responsible Party: Sang-Cheol Bae, Professor, MD, PhD, MPH, Hanyang University
ClinicalTrials.gov Identifier: NCT01685905     History of Changes
Other Study ID Numbers: TST_IGRA
Study First Received: September 12, 2012
Last Updated: September 17, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Hanyang University:
rheumatic disease, latent tuberculosis

Additional relevant MeSH terms:
Bone Diseases, Infectious
Arthritis, Rheumatoid
Latent Tuberculosis
Rheumatic Diseases
Spondylitis
Spondylitis, Ankylosing
Tuberculosis
Actinomycetales Infections
Ankylosis
Arthritis
Autoimmune Diseases
Bacterial Infections
Bone Diseases
Connective Tissue Diseases
Gram-Positive Bacterial Infections
Immune System Diseases
Infection
Joint Diseases
Musculoskeletal Diseases
Mycobacterium Infections
Spinal Diseases
Spondylarthritis
Spondylarthropathies

ClinicalTrials.gov processed this record on November 24, 2014