Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Patients and/or Caregivers to Assess Understanding of the Risks with the BKEMV™ Risk Evaluation and Mitigation Strategy (REMS) (20240214)

Study identification

• EU PAS number:
  EUPAS1000000368
• Study ID:
  1000000368
• Official title and acronym:
  Periodic Knowledge, Attitudes, and Behavior (KAB) Survey of Patients and/or Caregivers to Assess Understanding of the Risks with the BKEMV™ Risk Evaluation and Mitigation Strategy (REMS) (20240214)
• 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 patients who are at least 18 years of age and caregivers of patients of all ages who have been dispensed at least 1 dose of BKEMV 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:
  Ongoing

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned:04/11/2024

Actual:07/08/2023

Study start date

Planned:01/12/2025

Actual:01/12/2025

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 is a study 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

20240214