Study identification

PURI

https://redirect.ema.europa.eu/resource/1000000367

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

Networks

United BioSource Corporation (UBC)

Contact details

Annette Konikiewicz

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 study is funded by Amgen.
Study protocol
Initial protocol

Redacted Protocol-Published Original eculizumab biosimilar 20240216.pdf

English (2.21 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