Status: Planned First registered on: 01/11/2019
Last updated on: 05/11/2019
1. Study identification
EU PAS Register NumberEUPAS32142
Official titlePrescriber 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
Study title acronym
Study typeOther: PASS Survey
Brief description of the studyIn this post- authorisation safety study (PASS) a survey will be used to obtain information on the understanding, knowledge and behaviour of treating (or intending to treat) physicians on the screening and monitoring requirement for with highly active relapsing MS patients, to minimise the cardiotoxic and malignancy risk associated with the use of mitoxantrone. The objective of this study is to evaluate the awareness of the treating (or intending to treat) physicians on risk minimisation measures (RMMs) for patients with highly active relapsing MS associated with rapidly evolving disability, to minimise the cardiotoxic and malignancy risk associated with the use of mitoxantrone detailed in the EMs.
Was this study requested by a regulator?Yes: United Kingdom
Is the study required by a Risk Management Plan (RMP)? EU RMP category 3 (required)
Regulatory procedure number (RMP Category 1 and 2 studies only)
Other study registration identification numbers and URLs as applicable
2. Research centres and Investigator details
Coordinating study entity
Centre to which the investigator belongsIQVIA
Department/Research group
Organisation/affiliationIQVIA
Website/Homepagehttps://www.iqvia.com/
Details of (Primary) lead investigator
Title Dr
Last name Toussi
First name Massoud
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Not applicable (single centre)

Countries in which this study is being conducted
International study

France
Germany
Greece
Norway
Spain
Sweden
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed10/09/201923/09/2019
Start date of data collection03/07/2020
Start date of data analysis02/10/2020
Date of interim report, if expected
Date of final study report17/02/2021
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMYLAN Inc100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Toussi
First name Massoud
Address line 1Tour D2
Address line 217 bis Place des Reflets 
Address line 3 
CityCourbevoie 
Postcode92090 
CountryFrance
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address massoud.toussi@iqvia.com
Public Enquiries
Title Dr 
Last name Toussi 
First name Massoud 
Address line 1Tour D2 
Address line 217 bis Place des Reflets 
Address line 3 
CityCourbevoie 
Postcode92090 
CountryFrance 
Phone number (incl. country code)33-1413-51335 
Alternative phone number 
Fax number (incl. country code) 
Email address massoud.toussi@iqvia.com 
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