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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04973280
Recruitment Status : Completed
First Posted : July 22, 2021
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
Celgene

Study Description
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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.

Condition or disease
Myelodysplastic Syndromes Beta-thalassemia

Study Design
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Study Type : Observational
Actual Enrollment : 187 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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)
Actual Study Start Date : July 26, 2021
Actual Primary Completion Date : July 21, 2022
Actual Study Completion Date : July 21, 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
Healthcare Professionals (HCPs)
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.


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Up to 3 months ]
    Calculated as the percentage of healthcare professionals (HCPs) who answer "True" to question 1A

  2. 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 [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "False" to question 1B

  3. Knowledge that HCPs must counsel WCBP of the potential teratogenic risk of REBLOZYL [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "True" to question 1C

  4. Knowledge that for WCBP who become pregnant during treatment with REBLOZYL, the pregnancy outcome should be evaluated [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "False" to question 1D

  5. 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 [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "True" to question 1E

  6. Knowledge of what information about contraception methods should be provided when counselling WCBP [ Time Frame: 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

  7. Knowledge of how many pregnancy tests should be performed for WCBP before they start treatment with REBLOZYL [ Time Frame: 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

  8. Knowledge of the frequency pregnancy tests should be repeated for WCBP who are receiving treatment with REBLOZYL [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "At suitable intervals and medically verified as negative" to question 4

  9. Knowledge that WCBP should be informed to report a pregnancy that occurs during treatment with REBLOZYL and should receive counselling if they become pregnant [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "True" to question 5

  10. 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 [ Time Frame: 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

  11. Always providing WCBP with the REBLOZYL Patient Card [ Time Frame: 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)

  12. Composite knowledge for all 5 items in the core question set [ Time Frame: 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


Secondary Outcome Measures :
  1. Awareness of the HCP Checklist [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "Yes" to question 7

  2. Read/reviewed the HCP Checklist [ Time Frame: Up to 3 months ]
    Calculated as the percentage of HCPs who answer "Yes, all of it" or "Yes, some of it" to question 8

  3. Use of the HCP Checklist prior to initiating treatment [ Time Frame: Up to 3 months ]
    Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9A

  4. Use of the HCP Checklist at each subsequent administration [ Time Frame: Up to 3 months ]
    Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9B

  5. Use of the HCP Checklist for at least 3 months after stopping treatment [ Time Frame: Up to 3 months ]
    Calculated as percentages of HCPs who answer "Always" or "Sometimes" to question 9C

  6. Primary source from which HCPs learned about the appropriate indication, contraindications and precautions for use, and potential risks for REBLOZYL [ Time Frame: 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.)


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04973280


Locations
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Austria
Local Institution
City, State, Austria, 00000
Sponsors and Collaborators
Celgene
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Additional Information:

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Responsible Party: Celgene
ClinicalTrials.gov Identifier: NCT04973280    
Other Study ID Numbers: ACE-536-MDS-005
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.

Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at:

https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: See Plan Description
Access Criteria: See Plan Description
URL: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Celgene:
REBLOZYL
Myelodysplastic Syndromes
Healthcare Professionals
Post-authorization safety study
 Additional educational measures
Beta-thalassemia
Luspatercept
Additional relevant MeSH terms:
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Preleukemia
Myelodysplastic Syndromes
Thalassemia
beta-Thalassemia
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
 Neoplasms
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hemoglobinopathies
Genetic Diseases, Inborn