Clinical trial NCT04973280: Study to Evaluate Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndromes
Beta-thalassemia
Keywords: REBLOZYL
Myelodysplastic Syndromes
Healthcare Professionals
Post-authorization safety study
Additional educational measures
Beta-thalassemia
Luspatercept
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-07-22
Enrollment: 187
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthcare Professionals (HCPs) who were part of the REBLOZYL aRMMs dissemination list and who practice in any of the participating EEA countries.

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: 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
timeFrame: Up to 3 months
measure: 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
timeFrame: Up to 3 months
measure: Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL
timeFrame: Up to 3 months
measure: Knowledge that for WCBP who become pregnant during treatment with REBLOZYL, the pregnancy outcome should be evaluated
timeFrame: Up to 3 months
measure: 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
timeFrame: Up to 3 months
measure: Knowledge of what information about contraception methods should be provided when counselling WCBP
timeFrame: Up to 3 months
measure: Knowledge of how many pregnancy tests should be performed for WCBP before they start treatment with REBLOZYL
timeFrame: Up to 3 months
measure: Knowledge of the frequency pregnancy tests should be repeated for WCBP who are receiving treatment with REBLOZYL
timeFrame: Up to 3 months
measure: Knowledge that WCBP should be informed to report a pregnancy that occurs during treatment with REBLOZYL and should receive counselling if they become pregnant
timeFrame: Up to 3 months
measure: 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
timeFrame: Up to 3 months
measure: Always providing WCBP with the REBLOZYL Patient Card
timeFrame: Up to 3 months
measure: Composite knowledge for all 5 items in the core question set
timeFrame: Up to 3 months
Secondary outcomes:
measure: Awareness of the HCP Checklist
timeFrame: Up to 3 months
measure: Read/reviewed the HCP Checklist
timeFrame: Up to 3 months
measure: Use of the HCP Checklist prior to initiating treatment
timeFrame: Up to 3 months
measure: Use of the HCP Checklist at each subsequent administration
timeFrame: Up to 3 months
measure: Use of the HCP Checklist for at least 3 months after stopping treatment
timeFrame: Up to 3 months
measure: Primary source from which HCPs learned about the appropriate indication, contraindications and precautions for use, and potential risks for REBLOZYL
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Local Institutions
city: Brussels
country: Belgium
facility: Local Institutions
city: Berlin
country: Germany
facility: Local Institutions
city: Rome
country: Italy
facility: Local Institutions
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: