NCT04973280

Study to Evaluate Additional Risk Minimisation Measures (aRMMs) for REBLOZYL Among Healthcare Professionals (HCPs)

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 187 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Conditions

• Myelodysplastic Syndromes
• Beta-thalassemia

Timeline

• Start date: 2021-07-26
• Primary completion: 2022-07-21
• Completion: 2022-07-21
• First posted: 2021-07-22
• Last updated: 2024-07-12

Locations

4 sites across 4 countries: Austria, Belgium, Germany, Italy