A Study on Changes in IFN-gamma Levels Following Anti-TNF Treatment in Patients Undergoing Serial QuantiFERON-TB Gold In-Tube
This study has been completed.
Sponsor:
University of Roma La Sapienza
Information provided by (Responsible Party):
Rossana Scrivo, University of Roma La Sapienza
ClinicalTrials.gov Identifier:
NCT01475409
First received: November 10, 2011
Last updated: November 16, 2011
Last verified: November 2011
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
The screening for latent tuberculosis infection (LTBI) prior to the onset of anti-tumor necrosis factor therapy, as well as a watchful monitoring during the treatment, is strongly recommended. Tuberculin skin test (TST), universally used for this purpose, lacks sensitivity and specificity. The novel screening tools, including QuantiFERON-TB Gold In-Tube (QFT-GIT), have shown a higher specificity compared to TST, but their feasibility in the setting of immunosuppression remains unclear. Aims of this study were to investigate the performance of QFT-GIT and its agreement with TST in patients awaiting anti-tumor necrosis factor (TNF) therapy, and to evaluate the usefulness of serial QFT-GIT during the treatment with biologics to assess whether dynamic changes in interferon (IFN)-gamma levels may be helpful in identifying reactivation of LTBI or cases of newly acquired tuberculosis.
| Condition | Intervention |
|---|---|
|
Inflammatory Rheumatic Diseases |
Biological: QuantiFERON-TB Gold In-Tube (QFT-GIT) |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Dynamic Changes in IFN-gamma Plasma Levels Following Anti-TNF Treatment in Patients With Inflammatory Rheumatic Diseases Undergoing Serial QuantiFERON-TB Gold In-Tube Testing: a Prospective Study in a Low Tuberculosis Burden Country |
Resource links provided by NLM:
Further study details as provided by University of Roma La Sapienza:
Primary Outcome Measures:
- Change from baseline in IFN-gamma plasma levels following serial QFT-GIT testing during the treatment with anti-TNF agents [ Time Frame: From date of randomization (before anti-TNF treatment) until the date of repeated QFT-GIT testing (after 12 weeks and again after 24 weeks) for a total assessment of 7 months. ] [ Designated as safety issue: Yes ]QFT-GIT was performed at randomization (before commencement of anti-TNF treatment) and after 3 and 6 months since the beginning of biologicals.
Secondary Outcome Measures:
- Performance of QFT-GIT and its agreement with TST in patients under consideration for anti-TNF agents [ Time Frame: From date of randomization (before anti-TNF treatment) until the date of acquisition of QFT-GIT and TST results, for a total of 1 month. ] [ Designated as safety issue: Yes ]QFT-GIT and TST were performed at baseline, before the commencement of anti-TNF treatment.
| Enrollment: | 119 |
| Study Start Date: | July 2008 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: QuantiFERON-TB Gold In-Tube (QFT-GIT)
Patients were randomized to undergo, on the same day, tuberculin skin test (TST) and QFT-GIT by means of a randomization list to generate the order by which the 2 tests had to be executed. QFT-GIT was repeated after 3 and 6 months since TNF antagonist onset.
|
Biological: QuantiFERON-TB Gold In-Tube (QFT-GIT)
Patients were randomized to undergo, on the same day, TST and QFT-GIT by means of a randomization list to generate the order by which the 2 tests had to be executed. QFT-GIT was repeated after 3 and 6 months since TNF antagonist onset
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- clinical diagnosis of inflammatory rheumatic diseases
- patients candidates to anti-TNF treatment
Exclusion Criteria:
Contacts and Locations
No Contacts or Locations Provided
More Information
No publications provided
| Responsible Party: | Rossana Scrivo, Principal Investigator, University of Roma La Sapienza |
| ClinicalTrials.gov Identifier: | NCT01475409 History of Changes |
| Other Study ID Numbers: | URomLS01 |
| Study First Received: | November 10, 2011 |
| Last Updated: | November 16, 2011 |
| Health Authority: | Italy: Ethics Committee |
Keywords provided by University of Roma La Sapienza:
|
anti-TNF tuberculosis QuantiFERON-TB Gold In-Tube |
tuberculin skin test rheumatoid arthritis spondyloarthritis |
Additional relevant MeSH terms:
|
Rheumatic Diseases Tuberculosis Musculoskeletal Diseases Connective Tissue Diseases |
Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013