Post Authorization Safety Study on Assessment of Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Number of healthcare professionals who recall receiving and reading the additional risk minimization measures material for leflunomide distributed in 2022
研究概览
简要总结
The main objective of this post-authorization safety study is to assess healthcare professionals' awareness, knowledge, and behavior related to receipt and reading of the Direct Healthcare Professional Communication and educational materials for ARAVA® (leflunomide) and of the additional risk minimization measures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthcare professionals working only in Saudi Arabia
- •For Prescribers: Orthopedics, Internists, Family Physicians, General Practitioners, Dermatologists, Obstetricians/Gynecologists, Immunologists, and Rheumatologists who prescribed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion
- •For Prescribers: Physicians or pharmacists who have prescribed or dispensed leflunomide in a pre-specified period of the 6 months leading up to survey completion
- •For Pharmacists: Pharmacists (including clinical pharmacists) who have dispensed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion
排除标准
- •Healthcare professionals who may have conflicts of interest with the survey (i.e., employed by regulatory bodies or pharmaceutical companies)
- •Healthcare professionals (with a relative) involved in leflunomide -related lawsuits or associations for victims of leflunomide syndrome
- •Healthcare professionals who are not prescribing leflunomide
- •Healthcare professionals who have prescribed or dispensed leflunomide earlier than 6 months before the survey completion
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Leflunomide
Participants are healthcare professionals in Saudi Arabia completing a survey regarding experience prescribing/managing/dispensing leflunomide
干预措施: Leflunomide (Drug)
结局指标
主要结局
Number of healthcare professionals who recall receiving and reading the additional risk minimization measures material for leflunomide distributed in 2022
时间窗: 7 months
Number of healthcare professionals aware of the information reported in the educational materials and additional risk minimization measures material distributed in 2022
时间窗: 7 months
Number of healthcare professionals reported counseling their patients and conducting the needed laboratory investigations according to 2022 additional risk minimization measures material
时间窗: 7 months
次要结局
未报告次要终点