Clinical trial NCT02889965: The French Multiple Sclerosis Registry
Official title: The French Multiple Sclerosis Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Sclerosis
Neuromyelitis Optica Spectrum Disorders
Keywords: Multiple sclerosis
Pharmacoepidemiology
Disease modifying drugs
Neuro-myelitis optica
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 54000
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All MS and NMOSD patients domiciliated in France

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.


Eligibility criteria: 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

Exclusion Criteria:

NONE

-

Primary outcomes:
measure: Number of cases of MS included
timeFrame: 6 months up to 8 years
measure: number of patients
timeFrame: 6 months up to 8 years
measure: demographic characteristics
timeFrame: 6 months up to 8 years
measure: geographical distribution
timeFrame: 6 months up to 8 years
measure: disease characteristics
timeFrame: 6 months up to 8 years
measure: simple disease-modifying treatment description
timeFrame: 6 months up to 8 years
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer
Study officials:
affiliation: Hospices Civils de Lyon
name: Sandra VUKUSIC
role: PRINCIPAL_INVESTIGATOR
References: