OFSEP: The French Multiple Sclerosis Registry
Study Details
Study Description
Brief Summary
OFSEP is an observational cohort of Multiple Sclerosis (MS) and related disorders set up in France. It aims to provide a major epidemiological tool on MS for the scientific community in France and abroad. This tool must help to answer a large number of questions concerning the causes and mechanisms of MS, the prognostic factors of disease progression, the effectiveness and safety of therapeutic drugs, the impact of the disease on patients and society, etc.
In December 2015, it has already included more than 54.000 patients. To achieve this goal, OFSEP's objectives are
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To maintain and develop the French cohort of patients suffering from MS or related diseases and syndromes. This means collecting standardized socio-demographic and clinical data as part of the routine medical follow-up of patients already in the cohort and recruitment of new patients.
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To supplement the existing clinical data with standardized and quality biological samples and MRI scans.
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To improve the previous data with medical/administrative data from the health insurance fund databases in particular, in order to get more information on comorbidity, treatment protocols and the medico-economic aspects of this disease.
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To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.
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To ensure the availability of these data and samples to researchers, health care authorities and industrial players to enable analysis and thus provide answers to research questions or public health issues. This availability is only possible after scientific and regulatory evaluation of the request.
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To provide regular descriptions of the patient population in the cohort to offer statistics, targets and up-to-date information on this disease and thus enable a better approach to the personal, professional and social impacts of the illness, the effects of basic treatments and the requirements related to the follow-up of this disease in France.
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To conduct specific studies on the entire population of patients in the cohort (parent cohort) or on patient sub-groups with specific characteristics (nested cohorts). Four nested cohorts have been defined: patients with radiologically isolated syndromes, patients with clinically isolated syndromes, patients with primary progressive courses of the disease and patients with neuromyelitis optica (Devic's syndrome) spectrum disorders.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Radiologically Isolated Syndromes (RIS)
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| Clinically Isolated Syndromes (RIS)
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| Primary progressive MS (PPMS)
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Outcome Measures
Primary Outcome Measures
- Number of cases of MS included [6 months up to 8 years]
- number of patients [6 months up to 8 years]
- demographic characteristics [6 months up to 8 years]
- geographical distribution [6 months up to 8 years]
- disease characteristics [6 months up to 8 years]
- simple disease-modifying treatment description [6 months up to 8 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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RIS
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CIS
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MS according to McDonald 2010 criteria
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NMOSD and others as per NOMADMUS criteria
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No age limt
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All clinical courses
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Domiciliated in France
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Signed OFSEP informed consent
Exclusion Criteria:
NONE
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Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer | Bron | France | 69500 |
Sponsors and Collaborators
- Hospices Civils de Lyon
Investigators
- Principal Investigator: Sandra VUKUSIC, Hospices Civils de Lyon
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 69HCL14_0385