MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,408
- 试验地点
- 48
- 主要终点
- Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab
研究概览
简要总结
This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant is in the center to receive an infusion for rituximab for a non-oncology indication during the study period
- •Aged 18 years or older
排除标准
- •Has previously already completed the rituximab survey
- •Has participated in the past 12 months in a clinical trial in which rituximab was one of the treatments being evaluated.
结局指标
主要结局
Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab
时间窗: Up to 10 months
Percentage of Participants Using Rituximab Off-Label
时间窗: Up to 10 months
次要结局
- Percentage of Participants Who Received the Patient Alert Card (PAC)(Up to 10 months)
- Percentage of Participants Who Received Additional Safety-Related Materials(Up to 10 months)
- Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA)(Up to 10 months)
- Percentage of Participants Who Read the PAC(Up to 10 months)