OFSEP High Definition Cohort

  • STATUS
    Recruiting
  • End date
    Dec 16, 2023
  • participants needed
    5000
  • sponsor
    EDMUS Foundation
Updated on 16 February 2020
Investigator
Sandra VUKUSIC, MD
Primary Contact
CHU de Limoges (0.0 mi away) Contact
+26 other location

Summary

For neurologists and patients, it appears that one major unmet need, beside of course a cure to multiple sclerosis (MS), is to better appreciate the causal factors of disease progression, and even to obtain reliable predictive tools that could apply on the individual level and at different key moments in the disease course.

The overarching objective of the OFSEP-HD cohort is to determine prognostic factors of the evolution of disability in MS in real life, looking at disease characteristics, care practices potentially modifying the evolution of the disease since MS clinical onset and along specific post-onset landmarks. This general framework leads to study 3 specific research objectives:

  1. To identify determinants (socio-demographic characteristics, clinical characteristics, health related quality of life (QoL), changes in classification, and biomarkers) for the progression of MS disease and its consequences;
  2. To study the effectiveness of treatments in real life;
  3. To merge both determinants and treatments for creating patient-centered prognostic tools for identifying specific subgroups of patients and helping making decision to start, maintain or adapt care management.

To achieve these objectives, the OFSEP (The French multiple sclerosis registry) infrastructure, managed under a quality insurance system, offers a unique opportunity for the first time in France to create a large cohort of MS cases, providing high-definition and sequential multimodal data.

Details
Clinical Study IdentifierNCT03603457
SponsorEDMUS Foundation
Last Modified on16 February 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 15 yrs?
Gender: Male or Female
Do you have any of these conditions: Radiologically Isolated Syndrome or Multiple Sclerosis or Dermatite Atopique modérée ou grave?
Diagnosis of multiple sclerosis according to the most recent criteria at entry into the HD cohort
Followed in one MS Clinical Reference Centre (CRC SEP)
Newly diagnosed after the study start or
If MS onset occurred before study start, regular follow-up in a CRC SEP
Irreversible disability 7.0 (permanent use of a wheelchair) on EDSS at inclusion in the study
Non-inclusion Criteria
Inability to answer questionnaires
Pregnant women at the time of inclusion
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