Status: Finalised First registered on: 05/12/2017
Last updated on: 01/04/2019
1. Study identification
EU PAS Register NumberEUPAS21870
Official titleMalignancies in Multiple Sclerosis: multi-country cohort database studies (feasibility study)
Study title acronymMALBEC-f
Study typeOther: Study using data from the Echantillon Généraliste de bénéficiaires or if needed from SNIIRAM will be used
Brief description of the studyThe pattern of malignancies in the cladribine clinical program in multiple sclerosis (MS) (all exposed subjects) did not show an obvious difference compared to the available data on malignancies in the general population, or in MS patients. There is no obvious evidence of an increase of the risk of a particular tumor type in cladribine treated subjects compared to European reference populations. No dose-relationship could be found. The effect of age, immunomodulators (IM) and immunosuppressants (IS) treatments on the risk of malignancy in patients with MS is currently uncertain. MS patients seem to have a similar risk of malignancy than the general population but further studies using external data sources are needed to estimate the risk in MS as compared to general population. In this context, this study will provide estimates of malignancies incidence for a cohort of MS patients compared to non-MS patients of the general population, and for a cohort of MS patients newly treated with MS modifying drugs (DMDs), according to the type of medication used. This study will be done in 4 countries: France, the Netherlands, Denmark, United States. The overall results will be used with a view to a later post-marketing evaluation of cladribine.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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 belongsBordeaux PharmacoEpi
Department/Research grouppharmacoepidemiology
Organisation/affiliationUniversity of Bordeaux
Website/Homepagewww.pharmacoepi.eu
Details of (Primary) lead investigator
Title Dr
Last name Blin
First name Patrick
Is this study being carried out with the collaboration of a research network?
No
Other centres where this study is being conducted
Multiple centres

In total how many centres are involved in this Study?4

Countries in which this study is being conducted
International study

Denmark
France
Netherlands
United States
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed08/09/2017
Start date of data collection10/09/2017
Start date of data analysis01/11/2017
Date of interim report, if expected
Date of final study report31/12/201810/12/2018
4. Sources of funding
Please provide estimates of the percentage of funding by source for this study
Names(s)Approximate % funding
Pharmaceutical companiesMerck KGaA100
Charities
Government body
Research councils
EU funding scheme
5. Contact details for enquiries
Scientific Enquiries
Title Dr
Last name Blin
First name Patrick
Address line 1University of Bordeaux
Address line 2146 Rue Leo Saignat 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
Public Enquiries
Title Dr 
Last name Blin 
First name Patrick 
Address line 1University of Bordeaux 
Address line 2146 Rue Leo Saignat 
Address line 3 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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