Incidence of Tuberculosis in Patients With Autoimmune Rheumatic Diseases (TB-RESCREEN)
2026年8月14日 更新者：University of Sao Paulo General Hospital
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
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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
1660
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Eloisa SDO Bonfa, Full Professor
- 电话号码：+55 11 3061-7490
- 邮箱：reumatologia.fmusp@hc.fm.usp.br
学习地点
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São Paulo
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São Paulo、São Paulo、巴西、01246-903
- Rheumatology Division, Faculdade de Medicina da USP, São Paulo, SP
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接触：
- Eloisa SDO Bonfa, Full Professor
- 电话号码：+55 11 2661-8806
- 邮箱：reumatologia.fmusp@hc.fm.usp.br
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Patients (adults and children) diagnosed with autoimmune rheumatic diseases according to established international classification criteria
- negative baseline screening for tuberculosis infection.
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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. |
Routine annual TB re-screening after negative (IGRA)
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其他：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.
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Standard clinical follow-up without routine annual TB re-screening
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of Tuberculosis Disease
大体时间：Up to 48 months
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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).
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Up to 48 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adverse Events Related to TBI Treatment
大体时间：Up to 48 months
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Frequency of drug-related adverse events (e.g., hepatotoxicity)
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Up to 48 months
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Risk Factors for TBD Development
大体时间：Up to 48 months
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Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) for TBD development.
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Up to 48 months
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Rate of TBI Conversion
大体时间：Up to 36 months
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Proportion of patients converting from negative to positive IGRA during follow-up in the "annual IGRA rescreening group" (interventional arm).
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Up to 36 months
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Risk Factors for TBI Conversion
大体时间：Up to 36 months
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Identification of demographic, clinical, nutritional, and therapeutic predictors (e.g., type of biologic, corticosteroid use) in the "annual IGRA rescreening group" (interventional arm).
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Up to 36 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Gossec L, Smolen JS, Ramiro S, de Wit M, Cutolo M, Dougados M, Emery P, Landewe R, Oliver S, Aletaha D, Betteridge N, Braun J, Burmester G, Canete JD, Damjanov N, FitzGerald O, Haglund E, Helliwell P, Kvien TK, Lories R, Luger T, Maccarone M, Marzo-Ortega H, McGonagle D, McInnes IB, Olivieri I, Pavelka K, Schett G, Sieper J, van den Bosch F, Veale DJ, Wollenhaupt J, Zink A, van der Heijde D. European League Against Rheumatism (EULAR) recommendations for the management of psoriatic arthritis with pharmacological therapies: 2015 update. Ann Rheum Dis. 2016 Mar;75(3):499-510. doi: 10.1136/annrheumdis-2015-208337. Epub 2015 Dec 7.
- Bonfiglioli KR, Ribeiro AC, Moraes JC, Saad CG, Souza FH, Calich AL, Bonfa E, Laurindo IM. LTBI screening in rheumatoid arthritis patients prior to anti-TNF treatment in an endemic area. Int J Tuberc Lung Dis. 2014 Aug;18(8):905-11. doi: 10.5588/ijtld.13.0755.
- Yonekura CL, Oliveira RDR, Titton DC, Ranza R, Ranzolin A, Hayata AL, Duarte A, Silveira IG, Carvalho HMDS, Moraes JCB, Abreu MM, Valim V, Bianchi W, Brenol CV, Pereira IA, Costa I, Macieira JC, Miranda JRS, Guedes-Barbosa LS, Bertolo MB, Sauma MFLDC, Silva MBG, Freire M, Scheinberg MA, Toledo RA, Oliveira SKF, Fernandes V, Pinheiro MM, Castro G, Vieira WP, Baaklini CE, Ruffino-Netto A, Pinheiro GDRC, Laurindo IMM, Louzada-Junior P. Incidence of tuberculosis among patients with rheumatoid arthritis using TNF blockers in Brazil: data from the Brazilian Registry of Biological Therapies in Rheumatic Diseases (Registro Brasileiro de Monitoracao de Terapias Biologicas - BiobadaBrasil). Rev Bras Reumatol Engl Ed. 2017;57 Suppl 2:477-483. doi: 10.1016/j.rbre.2017.05.005. Epub 2017 Jul 22. English, Portuguese.
- Brunelli JB, Bonfiglioli KR, Silva CA, Kozu KT, Goldenstein-Schainberg C, Bonfa E, Aikawa NE. Latent tuberculosis infection screening in juvenile idiopathic arthritis patients preceding anti-TNF therapy in a tuberculosis high-risk country. Rev Bras Reumatol Engl Ed. 2017 Sep-Oct;57(5):392-396. doi: 10.1016/j.rbre.2016.11.004. Epub 2016 Dec 7. English, Portuguese.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月1日
初级完成 (估计的)
2030年7月30日
研究完成 (估计的)
2031年7月30日
研究注册日期
首次提交
2026年7月22日
首先提交符合 QC 标准的
2026年7月22日
首次发布 (实际的)
2026年7月28日
研究记录更新
最后更新发布 (实际的)
2026年8月18日
上次提交的符合 QC 标准的更新
2026年8月14日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.