Study to Evaluate Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs)
- Conditions
- Myelodysplastic SyndromesBeta-thalassemia
- Registration Number
- NCT04973280
- Lead Sponsor
- Celgene
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 187
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL 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 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 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 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 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 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 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method Use of the HCP Checklist prior to initiating treatment Up to 3 months Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9A
Use of the HCP Checklist at each subsequent administration Up to 3 months Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9B
Awareness of the HCP Checklist Up to 3 months Calculated as the percentage of HCPs who answer "Yes" to question 7
Use of the HCP Checklist for at least 3 months after stopping treatment Up to 3 months Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9C
Read/reviewed the HCP Checklist Up to 3 months Calculated as the percentage of HCPs who answer "Yes, all of it" or "Yes, some of it" to question 8
Primary source from which HCPs learned about the appropriate indication, contraindications and precautions for use, and potential risks for REBLOZYL Up to 3 months Calculated as the percentage of HCPs who tick each source in question 11 (for example, percentage of HCPs that ticked the REBLOZYL summary of product characteristics (SmPC), etc.)
Trial Locations
- Locations (1)
Local Institutions
🇮🇹Rome, Italy