Status: OngoingLast updated on: 26/07/2019
1. Study identification
EU PAS Register NumberEUPAS26535
Official titleMalignancies in Multiple Sclerosis: Multi-country cohort database studies – French Study
Study title acronymMALBEC
Study typeOther: Observationnal study
Brief description of the studyDisease Modifying Drugs (DMD) are used in the therapeutic management of Multiple Sclerosis (MS) to reduce the frequency of relapses and delay the progression of the disease. In the oral cladribine development program, efficacy data showed a significant effect of cladribine with a decrease in the frequency of relapses, associated lesions, and progression of MS. However, the safety results of the CLARITY Phase III pivotal study, evaluating cladribine versus placebo treatment in MS patients, revealed 4 cases of cancer in cladribine treated patients and no case in the placebo group. Taking into account safety and efficacy data, the European Medicines Agency Committee for Medicinal Products for Human Use issued a favourable marketing authorization opinion in June 2017 for cladribine in MS indication and conditioned by the achievement of a risk management plan defining cancer as a significant potential risk. In this context, the MALBEC study purpose is to supplement existing data by providing estimates of cancer incidence in the general population and in MS patients, whether or not treated with DMD, before the launch of cladribine (main objective). This study based on French nationwide healthcare insurance system database (SNDS) with data from the general scheme is part of a study program performed in three other countries (Denmark, the Netherlands, and the United States). The cohort will include all patients with a MS diagnosis, identified between 2007 and 2015 (inclusion date) by using hospitalization for MS, long term disease status or disability allowance with a diagnosis code of MS, or dispensing of DMD specific to MS, with a follow-up until the first date of death, occurrence of malignancy, or end of study period (31 Dec. 2015), and 1-year history prior inclusion date in the database. The crude annual incidence rates (exact Poisson) and standardized incidence rates will be calculated and stratified by age, gender, history of malignancy.
Was this study requested by a regulator?No
Is the study required by a Risk Management Plan (RMP)? Not applicable
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
Not applicable (single centre)

Countries in which this study is being conducted
National study

France
3. Study timelines: initial administrative steps, progress reports and final report
PlannedActual
Date when funding contract was signed01/06/2018
Start date of data collection01/05/201918/07/2019
Start date of data analysis01/05/201918/07/2019
Date of interim report, if expected
Date of final study report31/07/2020
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 1146 Rue Leo Saignat
Address line 2University of Bordeaux 
Address line 3Bâtiment du Tondu-case 41 
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 1146 Rue Leo Saignat 
Address line 2University of Bordeaux 
Address line 3Bâtiment du Tondu-case 41 
CityBordeaux 
Postcode33076 
CountryFrance 
Phone number (incl. country code)33557574675 
Alternative phone number 
Fax number (incl. country code)33557574740 
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