试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 576
- 主要终点
- Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
研究概览
简要总结
The goal of this study is to implement instruments that would increase the treating physician's awareness of the necessary tuberculosis screening when starting a new patient on infliximab (Remicade) therapy who has not reacted sufficiently to disease-modifying preparations, including methotrexate.
详细描述
This study used a non-probability sampling method.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with active rheumatoid arthritis confirmed with adequate clinical response(ACR) criteria who did not react sufficiently to disease-modifying preparations, including methotrexate, and who are receiving new treatment with infliximab.
排除标准
- •As per Summary of Product Characteristics (SmPC)
结局指标
主要结局
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
时间窗: Baseline
In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the In-vitro TB test (cellular blood test, i.e. gamma interferon release assays) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing
Number of Participants Who Had a Chest X-ray as Part of TB Screening for Active or Latent Tuberculosis Before Starting Treatment
时间窗: Baseline
In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). If done according to guidelines, complete TB screening comprised of a TB screening test and a chest X-ray. The number of participants who had a frontal chest X-ray was presented in three categories: * Yes * No * Missing
Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment
时间窗: Baseline
In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Mendel Mantoux test (Tuberculin sensitivity skin test by intradermal injection) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing
Number of Participants Who Had the Tine Test as the First Screening Test for Active or Latent Tuberculosis Before Starting Treatment
时间窗: Baseline
In order to increase the attending physician's awareness of the required tuberculosis screening and to support the screening itself, tuberculosis screening was performed and documented before treatment administration (baseline). The number of participants who had the Tine test (Multiple puncture Tuberculin skin test) per clinical testing as the first screening test was presented in three categories: * Yes * No * Missing
次要结局
未报告次要终点