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A Study on Changes in IFN-gamma Levels Following Anti-TNF Treatment in Patients Undergoing Serial QuantiFERON-TB Gold In-Tube

Primary Purpose

Inflammatory Rheumatic Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
QuantiFERON-TB Gold In-Tube (QFT-GIT)
Sponsored by
University of Roma La Sapienza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Rheumatic Diseases focused on measuring anti-TNF, tuberculosis, QuantiFERON-TB Gold In-Tube, tuberculin skin test, rheumatoid arthritis, spondyloarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • clinical diagnosis of inflammatory rheumatic diseases
  • patients candidates to anti-TNF treatment

Exclusion Criteria:

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    QuantiFERON-TB Gold In-Tube (QFT-GIT)

    Arm Description

    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.

    Outcomes

    Primary Outcome Measures

    Change from baseline in IFN-gamma plasma levels following serial QFT-GIT testing during the treatment with anti-TNF agents
    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
    QFT-GIT and TST were performed at baseline, before the commencement of anti-TNF treatment.

    Full Information

    First Posted
    November 10, 2011
    Last Updated
    November 16, 2011
    Sponsor
    University of Roma La Sapienza
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01475409
    Brief Title
    A Study on Changes in IFN-gamma Levels Following Anti-TNF Treatment in Patients Undergoing Serial QuantiFERON-TB Gold In-Tube
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2011
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2008 (undefined)
    Primary Completion Date
    February 2010 (Actual)
    Study Completion Date
    February 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Roma La Sapienza

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Rheumatic Diseases
    Keywords
    anti-TNF, tuberculosis, QuantiFERON-TB Gold In-Tube, tuberculin skin test, rheumatoid arthritis, spondyloarthritis

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    119 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    QuantiFERON-TB Gold In-Tube (QFT-GIT)
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Biological
    Intervention Name(s)
    QuantiFERON-TB Gold In-Tube (QFT-GIT)
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    Change from baseline in IFN-gamma plasma levels following serial QFT-GIT testing during the treatment with anti-TNF agents
    Description
    QFT-GIT was performed at randomization (before commencement of anti-TNF treatment) and after 3 and 6 months since the beginning of biologicals.
    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.
    Secondary Outcome Measure Information:
    Title
    Performance of QFT-GIT and its agreement with TST in patients under consideration for anti-TNF agents
    Description
    QFT-GIT and TST were performed at baseline, before the commencement of anti-TNF treatment.
    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.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: clinical diagnosis of inflammatory rheumatic diseases patients candidates to anti-TNF treatment Exclusion Criteria:

    12. IPD Sharing Statement

    Learn more about this trial

    A Study on Changes in IFN-gamma Levels Following Anti-TNF Treatment in Patients Undergoing Serial QuantiFERON-TB Gold In-Tube

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