The French Multiple Sclerosis Registry

Multiple Sclerosis Clinical Trial

— OFSEP  

Official title:

The French Multiple Sclerosis Registry

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02889965
• Other study ID #: 69HCL14_0385
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2016
• Last updated: September 6, 2016
• Start date: January 2011
• Est. completion date: December 2019

Study information

• Verified date: August 2016
• Source: Hospices Civils de Lyon
• Contact: Sandra VUKUSIC
• Phone: 33 4 72 35 73 42
• Email: sandra.vukusic[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54000
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 100 Years

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Neuromyelitis Optica
• Neuromyelitis Optica Spectrum Disorders
• Sclerosis

Locations

Country	Name	City	State
France	Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of cases of MS included		6 months up to 8 years	No
Primary	number of patients		6 months up to 8 years	No
Primary	demographic characteristics		6 months up to 8 years	No
Primary	geographical distribution		6 months up to 8 years	No
Primary	disease characteristics		6 months up to 8 years	No
Primary	simple disease-modifying treatment description		6 months up to 8 years	No