Infliximab-Pfizer Biosimilar Post-Marketing Database Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 2,207
- 试验地点
- 1
- 主要终点
- Incidence Rate of Serious Infections
研究概览
简要总结
The purpose of this study is to learn about the safety of the safety of the study medicine called infliximab for the possible treatment of rheumatoid arthritis (RA), ulcerative colitis (UC, Crohn's disease, or psoriasis.
RA is a kind of joint disease that causes pain and swelling.
UC causes inflammation and sores (also called ulcers), in the lining of the rectum and colon.
Chron's disease is a disease that lasts for a long time and causes severe irritation in your digestive tract.
Psoriasis is a skin disease that gives you a dry, scaly rash.
The study includes patient's data from the database who:
- Have at least 90 days of look-back period
- Have any of these diseases (RA, UC, Crohn's disease, or Psoriasis) in the 90-day look back period
- Are 15 years of age or older at the time of first dosing
All the patient's data included in this study would have received infliximab as intravenous (into veins) injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Incidence Rate of Serious Infections
时间窗: From index date up to 60 days after last dose
The observation of serious infections was expected to occur in an acute time period following any exposure. An incident event occurring during the 60-day risk window was counted in the numerator for the analysis and the person-time accrued until the first occurrence of an event, the end of the 60-day risk window, date of switch treatment, death, or the end of study period. Additionally, two types of analyses based on propensity score were conducted. For the full analysis set, 9 and 232 events occurred with a total of 151.9 and 2609.9 person-years in the Infliximab-Pfizer Biosimilar group and Remicade group, respectively. For the comparative analysis set, 5 and 232 events occurred with a total of 22.8 and 2609.9 person-years. For the comparative analysis set (IPTW weighted), 0.5 and 230.7 events occurred with a total of 3.6 and 2598.5 person-years. For the comparative matched analysis set, 5 and 6 events occurred with a total of 22.8 and 46.7 person-years.
次要结局
- Incidence Rate of Tuberculosis(From index date up to 60 days after last dose)
- Incidence Rate of Serious Blood Disorder(From index date up to 60 days after last dose)
- Incidence Rate of Interstitial Pneumonia(From index date up to 60 days after last dose)
- Incidence Rate of Malignancy(From index date up to the first incident event, death, end of the study period, or loss to follow-up)