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:
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
  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 April 22, 2014