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

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.

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Key information

Conditions

Inflammatory Rheumatic Diseases Actinomycetales Infections Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bacterial Infections Bacterial Infections and Mycoses Bone Diseases Connective Tissue Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Joint Diseases Musculoskeletal Diseases Mycobacterium Infections Rheumatic Diseases Skin and Connective Tissue Diseases Spinal Diseases Spondylarthritis Spondylitis Tuberculosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

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

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

Primary outcomes

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.

QFT-GIT was performed at randomization (before commencement of anti-TNF treatment) and after 3 and 6 months since the beginning of biologicals.

Secondary outcomes

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.

QFT-GIT and TST were performed at baseline, before the commencement of anti-TNF treatment.

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Nov 21, 2011
Registry last updated: Nov 21, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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