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

Myelodysplastic Syndromes Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04973280
• Other study ID #: ACE-536-MDS-005
• Status: Completed
• Start date: July 26, 2021
• Est. completion date: July 21, 2022

Study information

• Verified date: August 2022
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: July 21, 2022
• Est. primary completion date: July 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Beta-thalassemia
• Myelodysplastic Syndromes
• Preleukemia
• Thalassemia

Locations

Country	Name	City	State
Austria	Local Institution	City	State

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Calculated as the percentage of healthcare professionals (HCPs) who answer "True" to question 1A	Up to 3 months
Primary	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	Calculated as the percentage of HCPs who answer "False" to question 1B	Up to 3 months
Primary	Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL	Calculated as the percentage of HCPs who answer "True" to question 1C	Up to 3 months
Primary	Knowledge that for WCBP who become pregnant during treatment with REBLOZYL, the pregnancy outcome should be evaluated	Calculated as the percentage of HCPs who answer "False" to question 1D	Up to 3 months
Primary	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	Calculated as the percentage of HCPs who answer "True" to question 1E	Up to 3 months
Primary	Knowledge of what information about contraception methods should be provided when counselling WCBP	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	Up to 3 months
Primary	Knowledge of how many pregnancy tests should be performed for WCBP before they start treatment with REBLOZYL	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	Up to 3 months
Primary	Knowledge of the frequency pregnancy tests should be repeated for WCBP who are receiving treatment with REBLOZYL	Calculated as the percentage of HCPs who answer "At suitable intervals and medically verified as negative" to question 4	Up to 3 months
Primary	Knowledge that WCBP should be informed to report a pregnancy that occurs during treatment with REBLOZYL and should receive counselling if they become pregnant	Calculated as the percentage of HCPs who answer "True" to question 5	Up to 3 months
Primary	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	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	Up to 3 months
Primary	Always providing WCBP with the REBLOZYL Patient Card	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)	Up to 3 months
Primary	Composite knowledge for all 5 items in the core question set	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	Up to 3 months
Secondary	Awareness of the HCP Checklist	Calculated as the percentage of HCPs who answer "Yes" to question 7	Up to 3 months
Secondary	Read/reviewed the HCP Checklist	Calculated as the percentage of HCPs who answer "Yes, all of it" or "Yes, some of it" to question 8	Up to 3 months
Secondary	Use of the HCP Checklist prior to initiating treatment	Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9A	Up to 3 months
Secondary	Use of the HCP Checklist at each subsequent administration	Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9B	Up to 3 months
Secondary	Use of the HCP Checklist for at least 3 months after stopping treatment	Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9C	Up to 3 months
Secondary	Primary source from which HCPs learned about the appropriate indication, contraindications and precautions for use, and potential risks for REBLOZYL	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.)	Up to 3 months

External Links

•   BMS Clinical Trial Information