OFSEP HD cohort

OFSEP innovates with a new enhanced cohort. Some of the OFSEP registry patients will be followed-up on a yearly basis. Additional clinical, quality of life and other patient-reported data will be collected.

This study aims at developing personalized predictive tools to improve patient care management, and help in making decision to start, maintain or adapt medical care.

 

Fact sheet

Name: OFSEP HD Cohort
Title: Observatoire français de la sclérose en plaques (OFSEP) : cohorte haute définition (HD)
Sponsor: EDMUS Foundation against multiple sclerosis (for OFSEP)
Scientific coordinators: Prof. Sandra Vukusic, Prof. Francis Guillemin
Funding: French national research agency (ANR) and OFSEP
Inclusions: 2,842 patients
Status: Recruitment closed, ongoing follow-up
Start date: 01/07/2018
End date: 31/12/2026 (planned date)
Contact: This email address is being protected from spambots. You need JavaScript enabled to view it.

 

Project description

Objective

This high-definition cohort focuses on a sub-group of well-defined MS patients of OFSEP network selected sites. Its objective is to determine prognostic factors of MS disability evolution in real life regarding disease characteristics and care practices which may potentially affect the disease evolution, from MS onset and along four key specific post-onset landmarks:

  • MS diagnosis
  • Progression diagnosis (either primary or secondary)
  • A recent disease activity, defined by the occurrence of a relapse and/or MRI activity during the last 3 months
  • The absence of disease activity during the last 5 years, i.e. a “remission state”.

Such prognostic tools, including health-related Quality of Life (QoL) information, will allow the physician and the patient to make a more accurate therapeutic decision, based on a patient-centered decision making.

Beside this clinical objective, relevant methodological challenges will be addressed and economic analyses will be conducted.

 

Participating sites

All the French MS reference clinical centers (CRC SEP), nominated by the regional health authorities as defined in the French national neurodegenerative diseases program will participate.

 

Study population

Inclusion criteria:

  • Diagnosis of multiple sclerosis according to the most recent criteria
  • Age 15 or older
  • Follow-up in a MS Reference Clinical Centre (CRC SEP)
  • Not permanently wheelchair user (EDSS ≤7)

People included in OFSEP HD cohort must also be included in the OFSEP registry.

 

Study duration and number of subjects

Recruitment started in July 2018 and ended in September 2020. In total, 2842 patients were included.

OFSEP can continue the follow-up until December 2026.

 

Visit schedule

Patient visits are planned according to the study schedule, including an inclusion visit and annual follow-up visits, called “HD visits”. This rhythm is consistent with the usual patients management and allows additional visits if necessary.

The following data will be collected during HD visits:

  • OFSEP minimal data (socio-demographics data, neurological episodes, EDSS and irreversible disability, MRI, disease modifying treatment, serious adverse events)
  • Associated clinical data:
    • MSFC (disability and cognitive troubles), including the 9-hole PEG test, the timed 25-foot walk and a cognitive test on information processing speed, the CSCT.
    • Comorbidities, height, weight, Vitamin D if available, Anti-JCV status and index if available
  • Brain MRI, according to the OFSEP acquisition protocol
  • Self-report-questionnaires including quality of life (EQ5D, SF12, MusiQoL) and some exposure factors (from the Constances cohort).

At inclusion and every two years a blood sample is collected and banked. Potential markers of disease evolution will be measured: neurofilament, Glial Fibrillary Acidic Protein (GFAP) and vitamin D.

 

Studies included in OFSEP HD cohort scientific programme

Study of the representativeness of patients included in OFSEP HD cohort [REPRESENT-HD]

Scientific coordinators: Jonathan Epstein, Romain Casey

 

Can we accurately assess MS disease activity using automated methods in large real-life MRI databases? [COMETE].

Scientific coordinators: Anne Kerbrat, Benoit Combès

 

Multiple Sclerosis Genetics of OFSEP-HD cohort - Moving towards modeling and decoding Multiple Sclerosis progression

Scientific coordinator: Pierre-Antoine Gourraud

 

Comparing Caucasian and North-African MS evolution through the OFSEP-HD cohort [COCAUNAMS]

Scientific coordinators: David Laplaud, Yohann Foucher

 

Factors driving cost and burden of multiple sclerosis in France [MS-COSTDRIVERS]

Scientific coordinator: Hamza Achit

 

Determinants of the evolution of quality of life over time in OFSEP-HD

Scientific coordinators: Francis Guillemin, Jonathan Epstein, Hamza Achit

 

Career paths of people with MS in the OFSEP HD cohort [HD-WORK]

Scientific coordinators: Emmanuelle Leray, Sandra Vukusic

 

Applying PROgression definitions to a French MS cohort: Association to Patient Reported Outcome measures [PRO2]

Scientific coordinators: Laure Michel, Emmanuelle Leray