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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QuantiFERON-TB Gold In-Tube (QFT-GIT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D001172 | Arthritis, Rheumatoid |
| D025241 | Spondylarthritis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |