Impact of New Immunological Diagnosis Tests of Latent Tuberculosis in Adults Patients Who Need Anti TNF Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 430
- 试验地点
- 2
- 主要终点
- Therapeutic impact
研究概览
简要总结
Tuberculosis is a current infection during anti TNF therapy. After infectious contact, some patients will develop tuberculosis and some will only be infected without symptoms, they have Latent Tuberculosis Infection (LTBI) wich can reactivate later. In order to prevent this tuberculosis reactivation, LTBI diagnosis screening is preconised in patients who need anti TNF therapy. This diagnosis is made till now by the tuberculin skin test (TST) but this test is not specific of TB. New blood tests (QFTB-G and T-SPOT.TB) specific to MTB infection are now available.
The primary endpoint of this study is the evaluation of the theoric therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy
详细描述
Detailed description :
Principal outcome: Therapeutic impact of the use of new tests for diagnosis of LTBI in patients before anti TBF therapy
Secondary outcomes :
- medico-economic impact of replacement of TST by QFTB-G and T-SPOT.TB tests in LTBI screening in patients before anti TNF therapy.
- concordance of QFTB-G and T-SPOT.TB tests results with TST
- Concordance between QFTB-G and T-SPOT.TB tests and evaluation of indetermined tests.
- concordance of QFTB-G and T-SPOT.TB tests results with patient disease.
- concordance of QFTB-G and T-SPOT.TB tests results with TST in patients with LTBI determinated by clinical or radiological observation
- Impact of geographical, disease and treatment in patients with LTBI determinated by clinical or radiological observation
- Identify the original characteristic and maximal impact therapeutic of QFTB-G and T-SPOT.TB test
Analysed criteria :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years old
- •Patient with rheumatoid arthritis or Ankylosing spondylitis or Crohn's disease
- •Patient without Anti TNF treatment and who need one by infliximab, adalimumab or etanercept
- •Consent signed
- •Patient with social right
- •Patient who have been examined
排除标准
- •Pregnancy and breast feeding
结局指标
主要结局
Therapeutic impact
时间窗: 12 months
次要结局
- medico-economic impact(12 months)