Prospective Randomized Controlled Study to Evaluate the Effectiveness of Annual Tuberculosis Re-Screening in Patients With Autoimmune Rheumatic Diseases Receiving Biologic and/or Immunosuppressive Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,660
- 试验地点
- 1
- 主要终点
- Incidence of Tuberculosis Disease
研究概览
简要总结
This is a prospective, randomized, controlled study designed to evaluate the effectiveness of annual re-screening for tuberculosis infection (TBI) (previous) in patients with autoimmune rheumatic diseases (ARDs) receiving biologic and/or immunosuppressive therapy.
Patients with negative baseline TBI screening will be randomized to undergo annual re-screening using interferon-gamma release assay (IGRA) or to a control group without routine re-screening.
Patients with newly detected TBI will receive preventive treatment. The primary objective is to assess whether annual re-screening combined with TBI treatment reduces the incidence of active tuberculosis. Secondary objectives include determining TBI conversion rates and identifying risk factors for infection.
详细描述
Tuberculosis remains highly prevalent in endemic countries such as Brazil. Patients with autoimmune rheumatic diseases (ARDs) receiving immunosuppressive therapies, particularly biologic agents, are at increased risk of progression from tuberculosis infection (TBI) to tuberculosis disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
- •negative baseline screening for tuberculosis infection.
排除标准
- •History of tuberculosis infection or disease
- •Radiographic evidence suggestive of prior TB
- •Previous treatment for TBD or TBI
- •Positive baseline TB screening;
- •Follow-up shorter than 12 months
研究组 & 干预措施
No Rescreening
Patients will not repeat annual TB screening after the baseline negative evaluation (except in cases before the initiation of advanced therapy). They will continue standard clinical follow-up and monitoring for TBD symptoms.
干预措施: No Rescreening (Other)
Annual IGRA Rescreening
Patients will undergo repeated IGRA annually for 3 years after an initial negative screening. Baseline screening includes epidemiologic questionnaire, chest X-ray and interferon-gamma release assay (IGRA).
Patients with new positive results will be investigated (chest X ray and clinical synthons) for TBD. If negative, they will receive TBI indicated treatment.
干预措施: re-screening (Other)
结局指标
主要结局
Incidence of Tuberculosis Disease
时间窗: Up to 48 months
Incidence of confirmed TBD cases during the follow-up period among patients with autoimmune rheumatic diseases using biologic and/or Immunosuppressive therapy in both arms: "annual IGRA rescreening" (intervention arm) and "no rescreening" (standard clinical follow-up).
次要结局
- Risk Factors for TBI Development(Up to 36 months)
- Effect of TBI Treatment on TB Incidence(Up to 48 months)
- Adverse Events Related to TBI Treatment(Up to 48 months)
- Risk Factors for TBD Development(Up to 48 months)
- Rate of TBI Conversion(Up to 36 months)
- Risk Factors for TBI Conversion(Up to 36 months)