The French Multiple Sclerosis Registry (OFSEP)

• ClinicalTrials.gov Identifier: NCT02889965
• Recruitment Status: Unknown
• First Posted: September 7, 2016
• Last Update Posted: September 7, 2016
• Sponsor: Hospices Civils de Lyon
• Information provided by (Responsible Party): Hospices Civils de Lyon

Tracking Information

• First Submitted Date: August 22, 2016
• First Posted Date: September 7, 2016
• Last Update Posted Date: September 7, 2016
• Study Start Date: January 2011
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 6, 2016)

• Number of cases of MS included [ Time Frame: 6 months up to 8 years ]
• number of patients [ Time Frame: 6 months up to 8 years ]
• demographic characteristics [ Time Frame: 6 months up to 8 years ]
• geographical distribution [ Time Frame: 6 months up to 8 years ]
• disease characteristics [ Time Frame: 6 months up to 8 years ]
• simple disease-modifying treatment description [ Time Frame: 6 months up to 8 years ]

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The French Multiple Sclerosis Registry
• Official Title: The French Multiple Sclerosis Registry

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: All MS and NMOSD patients domiciliated in France

Condition

• Multiple Sclerosis
• Neuromyelitis Optica Spectrum Disorders

• Intervention: Not Provided

Study Groups/Cohorts

• Radiologically Isolated Syndromes (RIS)
• Clinically Isolated Syndromes (RIS)
• Primary progressive MS (PPMS)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: September 6, 2016): 54000
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2019
• Estimated Primary Completion Date: December 2019 (Final data collection date for primary outcome measure)

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

-

Sex/Gender

• Sexes Eligible for Study: All

• Ages: up to 100 Years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT02889965
• Other Study ID Numbers: 69HCL14_0385
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Hospices Civils de Lyon
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospices Civils de Lyon
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sandra VUKUSIC; Hospices Civils de Lyon

• PRS Account: Hospices Civils de Lyon
• Verification Date: August 2016