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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

NCT ID: NCT01475409

Last Updated: 2011-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2011-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Inflammatory Rheumatic Diseases

Keywords

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anti-TNF tuberculosis QuantiFERON-TB Gold In-Tube tuberculin skin test rheumatoid arthritis spondyloarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

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

Intervention Type BIOLOGICAL

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

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* clinical diagnosis of inflammatory rheumatic diseases
* patients candidates to anti-TNF treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Roma La Sapienza

OTHER

Sponsor Role lead

Responsible Party

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Rossana Scrivo

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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URomLS01

Identifier Type: -

Identifier Source: org_study_id