The French Multiple Sclerosis Registry (OFSEP)

September 6, 2016 updated by: Hospices Civils de Lyon

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

54000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69500
        • Recruiting
        • Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 100 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All MS and NMOSD patients domiciliated in France

Description

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

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Radiologically Isolated Syndromes (RIS)
Clinically Isolated Syndromes (RIS)
Primary progressive MS (PPMS)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Sandra VUKUSIC, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

September 6, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL14_0385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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