A Study to Evaluate the Effectiveness of the Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs) in the European Economic Area (EEA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Celgene
- 入组人数
- 187
- 试验地点
- 1
- 主要终点
- Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL
研究概览
简要总结
This is a non-interventional post-authorization safety study (PASS) employing a cross sectional design to evaluate the effectiveness of the additional risk minimization measures (aRMMs) for REBLOZYL. A survey will be used to measure the knowledge and comprehension of the REBLOZYL aRMMs among European Economic Area (EEA) based healthcare professionals (HCPs). The PASS will be conducted among HCPs in a representative sample of EEA countries where REBLOZYL is commercially available, potentially including Austria, Germany, Italy, Norway, Sweden, the Netherlands, Poland, and Spain. Additional EEA countries may be included, as needed, based on commercial availability and reimbursement status.
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 (HCPs) experienced in treatment of haematological diseases who may intend to prescribe REBLOZYL in the participating European countries and were on the target group for dissemination of the additional risk minimization measures (aRMMs).
- •The HCP provides permission to share their responses in aggregate with European Medicines Agency (EMA) or National Competent Authorities (NCAs), if requested.
排除标准
- •HCPs who previously participated in the cognitive pre-testing of the survey questionnaires to be used for the study.
- •HCPs who have been direct employees of the marketing authorization holder (MAH), the EMA, or the study vendor within the past 5 years.
结局指标
主要结局
Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "True" to question 1C
Knowledge that for WCBP who become pregnant during treatment with REBLOZYL, the pregnancy outcome should be evaluated
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "False" to question 1D
Knowledge of how long after stopping treatment with REBLOZYL should WCBP be informed to report a pregnancy that occurs and should they receive counselling if they become pregnant
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "Pregnancies that occur within 3 months after stopping REBLOZYL should be reported and participants should receive counselling" to question 6
Knowledge that although there are no data from the use of REBLOZYL in pregnant women, studies in animals exposed to REBLOZYL have shown reproductive toxicity and embryo-fetal toxicity
时间窗: Up to 3 months
Calculated as the percentage of healthcare professionals (HCPs) who answer "True" to question 1A
Knowledge that the use of REBLOZYL is contraindicated during pregnancy and in WCBP who are not using at least 1 highly effective method of contraception
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "True" to question 1E
Knowledge of the frequency pregnancy tests should be repeated for WCBP who are receiving treatment with REBLOZYL
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "At suitable intervals and medically verified as negative" to question 4
Knowledge that WCBP should be informed to report a pregnancy that occurs during treatment with REBLOZYL and should receive counselling if they become pregnant
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "True" to question 5
Knowledge that women of childbearing potential (WCBP) who become pregnant during treatment with REBLOZYL should not continue REBLOZYL treatment even if they receive appropriate monitoring
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "False" to question 1B
Knowledge of how many pregnancy tests should be performed for WCBP before they start treatment with REBLOZYL
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "A single pregnancy test must be performed and medically verified before starting treatment with REBLOZYL" to question 3
Composite knowledge for all 5 items in the core question set
时间窗: Up to 3 months
A composite endpoint calculated as the percentage of HCPs who answer: None of questions 1E, 2, 3, 4, and 10-A correctly; 1 of questions 1E, 2, 3, 4, and 10-A correctly; 2 of questions 1E, 2, 3, 4, and 10-A correctly; 3 of questions 1E, 2, 3, 4, and 10-A correctly; 4 of questions 1E, 2, 3, 4, and 10-A correctly; All 5 of questions 1E, 2, 3, 4, and 10-A correctly
Always providing WCBP with the REBLOZYL Patient Card
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "Yes, always" to providing the REBLOZYL Patient Card to WCBP (question 10-A). The denominator for this variable is the n who answer question 10 (not the n who answer 10-A)
Knowledge of what information about contraception methods should be provided when counselling WCBP
时间窗: Up to 3 months
Calculated as the percentage of HCPs who answer "WCBP should use at least 1 highly effective method of contraception during treatment with REBLOZYL and for at least 3 months after stopping treatment" to question 2
次要结局
- Awareness of the HCP Checklist(Up to 3 months)
- Use of the HCP Checklist prior to initiating treatment(Up to 3 months)
- Use of the HCP Checklist at each subsequent administration(Up to 3 months)
- Use of the HCP Checklist for at least 3 months after stopping treatment(Up to 3 months)
- Read/reviewed the HCP Checklist(Up to 3 months)
- Primary source from which HCPs learned about the appropriate indication, contraindications and precautions for use, and potential risks for REBLOZYL(Up to 3 months)