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
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.

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
Connective Tissue Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 22, 2014