The French Multiple Sclerosis Registry

• Conditions: Neuromyelitis Optica Spectrum Disorders; Multiple Sclerosis

• Registration Number: NCT02889965
• Lead Sponsor: Hospices Civils de Lyon

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

* 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.

* To supplement the existing clinical data with standardized and quality biological samples and MRI scans.

* 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.

* To use OFSEP infrastructures to facilitate the implementation of specific studies requiring the collection of additional data or specific patient monitoring processes.

* 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.

* 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.

* 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2016-08
• Study First Submitted: 2016-08-22
• Study First Submitted QC: 2016-09-06
• Last Update Submitted: 2016-09-06
• Study First Posted: 2016-09-07
• Last Update Posted: 2016-09-07
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54000

Inclusion Criteria

• RIS
• CIS
• MS according to McDonald 2010 criteria
• NMOSD and others as per NOMADMUS criteria
• No age limt
• All clinical courses
• Domiciliated in France
• Signed OFSEP informed consent

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Exclusion Criteria

NONE

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
number of patients	6 months up to 8 years
geographical distribution	6 months up to 8 years
disease characteristics	6 months up to 8 years
Number of cases of MS included	6 months up to 8 years
demographic characteristics	6 months up to 8 years
simple disease-modifying treatment description	6 months up to 8 years

Trial Locations

Locations (1)

Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer; 🇫🇷 Bron, France