OFSEP – French observatory of multiple sclerosis

OFSEP was founded by Professor Christian CONFAVREUX and is coordinated in Lyon by the neurology department of Pierre Wertheimer neurological hospital  (Pr. Sandra VUKUSIC). The consortium gathers Eugène Devic EDMUS Foundation against multiple sclerosis, Claude Bernard University (UCBL1) and the civilian hospices of Lyon (HCL). The neurologists network is spread all over the French territory and connected to 61user centers of EDMUS (European Database for MUltiple Sclerosis). The OFSEP cohort is national and opened. It gathers more than 35 000 individuals affected by SEP, which represents half of the population concerned by the disease and residing in France. The OFSEP project uses the generalization of the longitudinal follow-up and the systematic association of clinical data to biological samples and to neuro-imaging and aims at enhancing the quality, the efficience and the security of the care, and to promote clinical research that are fundamental and translational in SEP.

Programme : "Cohorts 2010" in the framework of the "Future Investments"
Coordinator: Université Claude Bernard Lyon 1, Prof. Sandra VUKUSIC
o 31 hospitals and French expert centers
o 16 health networks “City-Hospital”
o Eugène Devic EDMUS Foundation
o the civilian hospices of Lyon (HCL)
o Lyon Ingénierie Projets (FR)
• Total cost: € 9.479.142
• Duration : 2011-2019
• Site web : www.ofsep.org


Multiple Sclerosis (MS) is a chronic disease of the central nervous system. It is the most common cause of neurological disability in young adults, around 1 person in 1000 being affected in Western countries. It begins on the average by age 30, i.e. at a crucial moment in the personal, family, professional and social structuring of the individual. It leads to permanent disability for decades with marginal effect on life expectancy. The burden of MS is huge for the society, circa 8.9 M€ per year in the EU. It is rapidly increasing with the approval and diffusion of new Disease Modifying Treatments (DMTs).


The general objectives of the present application are threefold:
1- to maintain and expand the nationwide cohort of PwMS, providing a “photograph” of MS in France which might lead to a unique source of information on the epidemiology of the disease, on its personal, familial, professional, and social consequences, and on the effect of DMTs;
2- to maintain and develop existing nested cohorts and to implement new ones, addressing specific issues such as the pharmaco-epidemiology of recently introduced DMTs and their cost-effectiveness;
3- to enrich currently available clinical data with biological samples, imaging material and medico-socio-economic data.

Concretely, the operational objectives are to:
1- Maintain and develop the nationwide French cohort of PwMS by: agreeing on the minimum amount of standardized data for the clinical, medico-socio-economic, biological, imaging, and therapeutic assessments of each patient included in the cohort; agreeing on the biological, genetic included, and imaging material to be stored for each patient; promoting systematic multimodal assessments and prospective longitudinal follow-up; implementing quality control procedures for each type of material.
2- Maintain and/or develop the centralizing facilities: the EDMUS software and Coordinating Center; a nationwide network of BRCs dedicated to MS; a nationwide network of Imaging Resource Centres (IRCs) dedicated to MS.
3- Maintain and develop existing studies: - assessing the efficacy of DMTs on the accumulation of disability in the long-term; - assessing the incidence/prevalence of cancers in PwMS relatively to the French general population and its possible variation with DMTs use; - updating the ‘historical’ Lyon natural history MS cohort to allow a final assessment of the prognosis of the disease in the very long term; - developing the childhood MS onset cohort for assessing its specific traits and effect of DMTs in this population; - developing the Devic’s neuromyelitis optica cohort for assessing disease course, prognostic factors, biological markers, pathophysiological pathways and therapeutic issues which could be paradigmatic for MS.
4- Implement new nested cohorts: - surveillance of safety and efficacy of new DMTs to come in the near future, within the frame of RMPs to be implemented by AFSSAPS; - setting up of a cohort of patients enrolled prospectively from their first episode (clinically isolated syndromes, CIS) and followed longitudinally with systematic multimodal assessments, to develop suitable and reliable predictive tools of the individual prognosis.
5- Set up a link between each OFSEP patient file and the Caisse Nationale d’Assurance Maladie des Travailleurs Salariés (CNAMTS), the Régime Social des Indépendants (RSI) or the Mutualité Sociale Agricole (MSA) file for following in parallel, longitudinally and prospectively, the evolution of the disease and of the medical costs related to the patient, and assessing the influence of the treatment status.
6- Develop a collaboration with the Haute Autorité de Santé (HAS), namely its ‘Commission de Transparence’ in the assessment of DMTs efficacy.
7- Open access to the data/samples of this cohort to research institutions, public or private, and to the pharmaceutical industry for promoting translational and basic research.
• A randomized preoperative radiotherapy trial in retroperitoneal sarcomas (N=1 trial)
• A randomized neoadjuvant cytotoxic chemotherapy trial in localized tumours (N=2 trial)
• 6 trials exploring targeted therapies in rare sarcoma subtypes in prospective randomized trials and in phase II proof of concept studies Biological and clinical material that will be collected in this trial will then be used to perform translational research on these tumours, and to characterize in depth their molecular alterations as well as the effects of drug interventions within the tumours.

Impact/Expected results

The OFSEP Project has a high potential and promises huge dividends. Making this large homogeneous cohort available and this organization implementable with a guarantee of strong, continuous and protracted human and material support for such a chronic disease as MS will offer PwMS, their relatives, physicians, researchers, pharmaceutical industry, public health services, and economists a nationwide and comprehensive “grand instrument épidémiologique” unique in the world. This will place France in an ideal position for translational research and development of innovative therapies in MS. This instrument is so relevant that it has drawn the attention of political decision-makers, national (AFSEP, APF, LFSEP, UNISEP) and international (EMSP) PwMS associations, and the international MS scientific society (ECTRIMS) who see in it a unique opportunity to improve the quality of life of persons suffering from this devastating and widespread disease.

What about LIP?

LIP assisted the founders to set up the project, to find appropriate partners and relevant funding sources, to define strategic objectives and governance model, and to shape the financial and administrative framework of the project. LIP is also partner of the project, in charge of the operational monitoring and works actively to turn the observatory into a perennial structure.

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