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The French Multiple Sclerosis Registry (OFSEP)

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ClinicalTrials.gov Identifier: NCT02889965
Recruitment Status : Unknown
Verified August 2016 by Hospices Civils de Lyon.
Recruitment status was:  Recruiting
First Posted : September 7, 2016
Last Update Posted : September 7, 2016
Sponsor:
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators
Principal Investigator: Sandra VUKUSIC Hospices Civils de Lyon
PRS Account Hospices Civils de Lyon
Verification Date August 2016