Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Certified Prescribers to Assess Understanding of the Risks with the BKEMV™ Risk Evaluation and Mitigation Strategy (REMS) (20240216)

Study identification

• EU PAS number:
  EUPAS1000000367
• Study ID:
  1000000367
• Official title and acronym:
  Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Certified Prescribers to Assess Understanding of the Risks with the BKEMV™ Risk Evaluation and Mitigation Strategy (REMS) (20240216)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  The proposed study is a Risk Evaluation and Mitigation Strategy (REMS) post-marketing safety program that will be monitored by the FDA to ensure the drug (ABP 959 – BKEMV) benefits outweigh its risks. ; The study will survey healthcare providers (HCP) who are currently prescribing and those who have potential to prescribe BKEMV, who are part of the REMS Communication Plan Outreach, and who have not been debarred or sanctioned in order to assess their knowledge and understanding of the risk of severe meningococcal infections with BKEMV, the BKEMV REM requirements, and the REMS goals and materials.
• Study status:
  Planned

Research institutions and networks

Institutions

United BioSource Corporation (UBC)

Switzerland

Networks

United BioSource Corporation (UBC)

Study timelines

Date when funding contract was signed

Planned: 07/08/2023

Actual: 07/08/2023

Study start date

Planned: 03/09/2025

Data analysis start date

Planned: 30/03/2026

Date of interim report, if expected

Planned: 28/05/2027

Date of final study report

Planned: 28/05/2027

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

This study is funded by Amgen.

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only

Other study registration identification numbers and links

20240216