Post Marketing Surveillance Study of the Labeled Use of Remicade® (Infliximab) in Patients With Chronic Inflammatory Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,485
- 主要终点
- Number of Participants Experiencing at Least One Adverse Event
研究概览
简要总结
This study will be performed to evaluate and document the safety and efficacy of infliximab (Remicade®) in the treatment of chronic inflammatory diseases in big cohorts in the daily routine practice of rheumatologists, gastroenterologists, and dermatologists.
详细描述
The study population was chosen from a non-probability sample.
The safety population consisted of all participants with at least one documented infusion of infliximab.
The evaluable population consisted of all participants that were >=18 years of age with a recorded indication for infliximab use, that had available baseline data, and with at least 3 infusions of infliximab within the first 16 weeks of the study. Baseline characteristics are provided for this population.
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
- •Participants treated with infliximab by rheumatologists, gastroenterologists, and dermatologists for chronic inflammatory diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, or Crohn's disease.
排除标准
- 未提供
结局指标
主要结局
Number of Participants Experiencing at Least One Adverse Event
时间窗: Baseline to Month 24
An adverse event was defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the treatment, whether or not considered related to the use of the product. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the treatment, was also an adverse event.
次要结局
- Clinicians' Impression of Disease Severity From Baseline to Week 102(Baseline, Week 6, Week 14, Week 22, Week 54, Week 102)
- Clinicians' Impression of Therapeutic Efficacy(Week 6, Week 14, Week 22, Week 54, Week 102)