跳至主要内容
临床试验/NCT01223976
NCT01223976Unknown4 期

Sensitivity and Specificity of QuantiFeron -TB Gold Test (QFT-G)in Comparison With Tuberculin Skin Test in Patients With Psoriasis and Psoriatic Arthritis

Tel-Aviv Sourasky Medical Center2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年11月最近更新:
适应症

试验速览

阶段
4 期
入组人数
150
试验地点
2
主要终点
The level of agreement between TST and QTF in patients with psoriasis in comparison with controls

研究概览

简要总结

The purpose of this study is to determine the level of agreement between QuantiFeron -TB Gold test (QFT-G)and Tubeculin skin test (TST)for screening of latent tuberculosis in patients suffering from psoriasis.

详细描述

Patients with psoriasis and psoriatic arthritis are candidates to receive anti-TNF alpha therapies which require prior screening for latent tuberculosis (LTB). Currently, screening for LTB is based on tuberculin skin test (TST) , chest X rays, and a questionaire on predisposing factors for TB. The main drawbacks of TST are the lack of specificity due to cross reactivity with Bacille Calmette- Guerin (BCG) and other nontuberculosis mycobacteria and the risk of anergy in immunosuppressed patients. Furthermore, it has been suggested that the skin of psoriatic patients may be more sensitive resulting in increased TST which does not obligatory reflect the status of LTB.

Recently, a new assay for LTBI has been developed, which evaluates interferon (IFN) -γ release by memory effector T-cells stimulated in vitro with specific mycobacterial antigens, ESAT-6 (early secretory antigen target-6) and CFP-10 (culture filtrate protein-10) [9-10]. The QuantiFeron -TB Gold test (QFT-G) uses ELISA to measure IFN-γ concentrations in supernatants in plate format and "In tube" format (QFT-GIT) while the enzyme-linked immunospot (ELISPOT) detects individual IFN-γ producing T-cells (TS-TB, Oxford Immunotech, Abingdon, UK).

The whole blood IFN-γ assays was approved by The Centers for Disease Control as an alternative screening strategy to TST in immunocompetent individuals [11], but its clinical utility as a single test for detection LTBI in immunocompromised patients is controversial.Furthermore, its utility in patients with psoriasis and psoriatic arthritis has not been yet established One hundred patients with psoriasis and psoriatic arthritis and 50 healthy control will participate in this study.

Enrolled subjects will be requested to complete a detailed sociodemographic and TB screening questionnaire including gender, age, place of birth and work, prior BCG vaccination, close contact with TB patients or TB prophylaxis in the past. Screening workup will includ assessment of clinical disease activity using the Disease Activity Score 28 (DAS-28)and Psoriasis Area Severity Index (PASI),documentation of past or current treatment with systemic corticosteroids and immunosuppressive drugs, and imaging (chest X-ray).

All the subjects will undergo a TST and QFT-G test A 2-TU dose of PPD will be administered by a certified technician using the Mantoux method and induration measured after 72 h. TST will be deemed positive if bove or equally to 5 mm for RA patients and 10 mm for controls The absence of induration of <2 mm in diameter will be recorded as anergic and negative TST results was defined as having more than 2 but less than 5 mm reactions for RA patients.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with psoriasis and psoriatic arthritis
  • Aged 18-90

排除标准

  • History of TB
  • Known allergy to TST
  • Current or past treatment with anti-TNF alpha

结局指标

主要结局

The level of agreement between TST and QTF in patients with psoriasis in comparison with controls

时间窗: 3 days

次要结局

  • Levels of TST in patients with psoriasis in comparison with healthy controls(3 days)

研究者

申办方类型
Other Gov

研究点 (2)

Loading locations...

相似试验

Sensitivity and Specificity of QuantiFeron -TB Gold... | 临床试验