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The French Multiple Sclerosis Registry (OFSEP)

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ClinicalTrials.gov Identifier: NCT02889965
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Multiple Sclerosis Neuromyelitis Optica Spectrum Disorders

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Study Type : Observational
Estimated Enrollment : 54000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The French Multiple Sclerosis Registry
Study Start Date : January 2011
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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



Primary Outcome Measures :
  1. Number of cases of MS included [ Time Frame: 6 months up to 8 years ]
  2. number of patients [ Time Frame: 6 months up to 8 years ]
  3. demographic characteristics [ Time Frame: 6 months up to 8 years ]
  4. geographical distribution [ Time Frame: 6 months up to 8 years ]
  5. disease characteristics [ Time Frame: 6 months up to 8 years ]
  6. simple disease-modifying treatment description [ Time Frame: 6 months up to 8 years ]


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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All MS and NMOSD patients domiciliated in France
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

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02889965


Contacts
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Contact: Sandra VUKUSIC 33 4 72 35 73 42 sandra.vukusic@chu-lyon.fr
Contact: Véronique MILLOT 33 4 72 35 73 42 veronique.millot@chu-lyon.fr

Locations
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France
Hospices Civils de Lyon / Hopital Neurologique Pierre Wertheimer Recruiting
Bron, France, 69500
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Sandra VUKUSIC Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02889965     History of Changes
Other Study ID Numbers: 69HCL14_0385
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Hospices Civils de Lyon:
Multiple sclerosis
Pharmacoepidemiology
Disease modifying drugs
Neuro-myelitis optica
Additional relevant MeSH terms:
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Multiple Sclerosis
Neuromyelitis Optica
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Myelitis, Transverse
Optic Neuritis
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases