Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000368

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

Planned
Research institutions and networks

Institutions

Amgen
United States
First published:
21/02/2024
Institution

Contact details

Global Development Leader Amgen Inc.

Primary lead investigator
Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

This is a study funded by Amgen.
Study protocol
Initial protocol

Protocol-Published Original eculizumab biosimilar 20240214 .pdf

English (2.47 MB - PDF)View document
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

Non-EU RMP only