Study identification

EU PAS number

EUPAS32142

Study ID

43380

Official title and acronym

Prescriber survey to evaluate the awareness to risk minimisation measures for mitoxantrone-containing medicinal products in the treatment of patients with highly active relapsing multiple sclerosis associated with rapidly evolving disability

DARWIN EU® study

No

Study countries

France
Germany
Greece
Norway
Spain
Sweden

Study description

Mitoxantrone is indicated for the treatment of numerous malignancies, such as metastatic breast cancer, non-Hodgkin’s lymphoma and acute myeloid leukaemia in adults. Mitoxantrone is also indicated for the treatment of patients with highly active relapsing multiple sclerosis (MS) associated with rapidly evolving disability, where no alternative therapeutic options exist. In this post- authorisation safety study (PASS) a survey will be used to obtain information on the understanding, knowledge and self-declared behaviour of treating (or intending to treat) neurologists on the screening and monitoring requirement for highly active relapsing MS patients, to minimise the cardiotoxic and malignancy risk associated with the use of mitoxantrone.

Study status

Ongoing
Research institutions and networks

Institutions

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

Contact details

Massoud Toussi

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

MYLAN Inc
Regulatory

Was the study required by a regulatory body?

Yes

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

EU RMP category 3 (required)