Remicade Safety Line (Ankylosing Spondylitis)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 320
- 主要终点
- Number of Participants Who Had the Mendel Mantoux Test as the First Screening Test for Active or Latent Tuberculosis (TB) Before Starting Treatment
研究概览
简要总结
This observational study is in line with the German educational plan with the aim to implement a tool to increase and monitor the awareness of tuberculosis screening and to reinforce the patient eligibility for a treatment with Remicade according to the Summary of Product Characteristics (SmPc).
详细描述
This study population was chosen from a non-probability sample.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Subjects with ankylosing spondylitis.
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 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) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)
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) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)
Number of Participants Who Had the In-vitro TB Test as the First Screening Test for Active or Latent Tuberculosis Before Starting
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) as the first screening test was presented in three categories: * Yes * No * Missing (represents no entry, but may mean another test was performed as first screening test and documented)
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 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
次要结局
- Assessment of Disease Activity by Means of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at the Time of Enrollment and at the First Infusion(Baseline and time of first infusion)