Study identification

EU PAS number

EUPAS1000000863

Study ID

1000000863

Official title and acronym

EVALUATION OF THE EFFECTIVENESS OF THE ADDITIONAL RISK MINIMISATION MEASURES FOR GLOFITAMAB: A PASS SURVEY AMONG HEALTHCARE PROFESSIONALS IN EUROPEAN COUNTRIES

DARWIN EU® study

No

Study countries

Austria
Belgium
Bulgaria
Croatia
France
Germany
Greece
Italy
Norway
Portugal
Sweden

Study description

This study focuses on the important identified risk of Tumor Flare (TF) for Glofitamab and its additional Risk Minimisation Measures (aRMMs), in the form of an Health Care Professional (HCP) brochure. The HCP brochure is intended to educate and increase HCP awareness and understanding of the key signs and symptoms of TF so that HCPs can identify and manage the risks in a timely and appropriate manner.

Therefore, the study aims to evaluate the effectiveness of the HCP brochure on physicians prescribing Glofitamab to ensure that prescribers are able to recognise early signs and symptoms of TF and provide appropriate management.

To fulfil a Category III Post-Authorisation Safety Study (PASS), the Marketing Authorisation Holder (MAH) proposed a non-interventional (NI) PASS through an HCP survey as detailed in the Risk Management Plan (RMP) for Glofitamab, to evaluate the effectiveness of the aRMMs. The survey will assess awareness, knowledge, and adherence of Glofitamab prescribers to the aRMMs plan.

Study status

Planned
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Sophie Jouaville Abrouk

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

F. Hoffmann-La Roche Ltd
Regulatory

Was the study required by a regulatory body?

No

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

EU RMP category 3 (required)