Long-term Safety Follow-up of REMICADE (RESULTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,971
- 主要终点
- Number of patients with each of the following long-term safety events
研究概览
简要总结
This is a study evaluating the long-term safety of infliximab (Remicade)
详细描述
The purpose of this study is to collect long-term safety information on infliximab (Remicade) from patients who participate in research studies using those drugs. All patients in these studies are being asked to participate in this long-term safety follow-up study which will provide important information about the study drug. The long-term effect of the study drug on survival, serious infections, new malignancies and new autoimmune diseases will be measured from data collected over a 5-year period. Additional information about possible delayed allergic reactions (possible fever, rash, fatigue, joint pain) will also be collected if you received infliximab (Remicade) after the end of the primary study. Study participation in this research study is 5 years after the end of the primary study. Questionnaires will be completed about patient's health and the occurrence of these safety events at intervals of 6 months, 1 year, 2 years, 3 years, 4 years and 5 years after patients complete participation in the primary study.
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
- •All patients enrolled in ongoing and future Centocor sponsored infliximab clinical studies that require long-term safety follow-up (ie, primary studies). Patients must have received at least 1 dose of study agent to be eligible for participation in the study
排除标准
- •Did not previously participate in Centocor sponsored infliximab clinical studies.
研究组 & 干预措施
Patients in infliximab clinical studies
All patients enrolled in selected Centocor sponsored infliximab clinical studies.
干预措施: Infliximab (Remicade) (Drug)
结局指标
主要结局
Number of patients with each of the following long-term safety events
时间窗: Five years
Number of patients with each of the following long-term safety events: serious infections, new malignancies, new autoimmune diseases, death, or delayed hypersensitivity (serum sickness-like) reactions.
次要结局
- Number of patients with malignancies by malignancy type(Five years)
- Number of patients with serious infections by type of infection(Five years)
