Rheumatic DiseaseNCT01685905
The Usefulness of Interferon-γ Release Assays and Tuberculin Skin Test for Detection of Latent Tuberculosis Infection
An observational study of Rheumatic Disease and Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Rheumatic Disease, Rheumatoid Arthritis, Ankylosing Spondylitis
- How many people
- 2,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2012to Sep 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older 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
Who may be able to join
- patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Hanyang University Hospital for rheumatic disease
Seoul, Sung-dong Gu, 133-792
Sang-cheol Bae, MD, 82-2-2290-9230, scbae@hanyang.ac.kr
About this study
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
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.
Read the 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).
- Keywords
- rheumatic disease, latent tuberculosis
- Medical subject headings
- Rheumatic Diseases, Arthritis, Rheumatoid, Spondylitis, Ankylosing, Tuberculosis, Latent Tuberculosis
What is being measured
The primary outcome is the main question the study is designed to answer.
The agreement between QuantiFERON-TB Gold(QFT-G) and tuberculin skin test(TST) as a screening test for latent tuberculosis infection(LTBI)
Measured: one year
Secondary outcomes (1)
The correlation of the occurrence of active Tuberculosis and two tests (QuantiFERON-TB Gold (QFT-G) and tuberculosis skin test(TST))
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startApr 2012
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Principal investigator, Sang-Cheol Bae, Hanyang University
- Investigators
- Sang-cheol Bae, director, Principal investigator, Hanyang University Hospital for Rheumatic Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685905
- Sponsor's protocol ID
- TST_IGRA
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2012
- Last updated
- 18 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01685905
- Acronym / sponsor ID
- TST_IGRA
- Keywords
- rheumatic disease, latent tuberculosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- Apr 2012
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older 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
Key inclusion criteria (1 listed)
- patients with rheumatic diseases who examined TST or QFT-G in Hanyang university hospital from 2004 to 2010
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sang-cheol Bae, director principal investigator
Hanyang University Hospital for Rheumatic Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Disease and Rheumatoid Arthritis, run by Hanyang University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sang-cheol Bae, director (82-2-2290-8260, scbae@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2012.