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

Brief Title

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)

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.
    



Study Type

Observational


Primary Outcome

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

Secondary Outcome

 Awareness of the HCP Checklist

Condition

Myelodysplastic Syndromes


Study Arms / Comparison Groups

 Healthcare Professionals (HCPs)
Description:  The PASS will be conducted among HCPs in a representative sample of EEA countries where REBLOZYL is commercially available. A sample of HCPs from EEA countries who manage care for patients with certain haematologic conditions and who may/do prescribe REBLOZYL will be recruited from the target population of HCPs who were sent the REBLOZYL aRMMs in these countries. The final list of countries to be included may include 1) only countries where reimbursement has been sought and gained, 2) a geographically representative sample (e.g., northern, southern, eastern, and western EU Members States to the degree possible based on the first criteria), 3) a mixture of countries with higher and lower REBLOZYL usage, and 4) other feasibility considerations such as the ability to conduct direct-to-HCP non-market research studies.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

200

Start Date

July 20, 2021

Completion Date

September 30, 2022

Primary Completion Date

September 30, 2022

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.
      

Gender

All

Ages

N/A - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Susanna Carou-Keenan, PharmD, MBA, please email:, [email protected]



Administrative Informations


NCT ID

NCT04973280

Organization ID

ACE-536-MDS-005


Responsible Party

Sponsor

Study Sponsor

Celgene


Study Sponsor

Susanna Carou-Keenan, PharmD, MBA, Study Director, Celgene


Verification Date

July 2021