OFSEP High Definition Cohort (OFSEP HD)

August 28, 2023 updated by: EDMUS Foundation

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

2900

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
      • Amiens, France
        • CHU d'Amiens
      • Besançon, France
        • CHU de Besancon
      • Bordeaux, France
        • CHU de Bordeaux
      • Caen, France
        • CHU de Caen
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand
      • Créteil, France
        • CHU de Créteil
      • Dijon, France
        • CHU de Dijon
      • Grenoble, France
        • CHU de Grenoble
      • Lille, France
        • CHU de Lille
      • Limoges, France
        • CHU de Limoges
      • Lyon, France
        • Chu de Lyon
      • Marseille, France
        • CHU de Marseille
      • Montpellier, France
        • CHU de Montpellier
      • Nancy, France
        • Chu de Nancy
      • Nantes, France
        • CHU de Nantes
      • Nice, France
        • CHU de Nice
      • Nîmes, France
        • CHU de Nîmes
      • Paris, France
        • Fondation Rothschild
      • Paris, France
        • CHU Pitié-Salpêtrière
      • Paris, France
        • CHU Saint-Antoine
      • Poissy, France
        • CHI de Poissy-Saint-Germain-en-Laye
      • Poitiers, France
        • CHU de Poitiers
      • Rennes, France
        • CHU de Rennes
      • Strasbourg, France
        • CHU de Strasbourg
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France
        • CHU de Tours
  • Martinique
      • Fort-de-France, Martinique
        • CHU de Fort-de-France

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

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All MS patients from MS Clinical Reference Centre (CRC SEP).

Description

Inclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6
Time Frame: Through study completion, an average of 2 years
Through study completion, an average of 2 years
Activity of disease
Time Frame: 1 year
Activity is determined, according Lublin 2014, by clinical relapses and/or MRI activity (contrast-enhancing lesions ; new or unequivocally enlarging T2 lesions assessed at least annually)
1 year
Change in T2 lesion load evaluated by analysis of raw MRI
Time Frame: 1 year
1 year
Change in quality of life evaluated by EQ-5D-5L scale
Time Frame: 1 year

The 5-level EQ-5D version (EQ-5D-5L) consists of the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS).

The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The five dimensions can be combined into a number that describes the patient's health state.

The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
1 year
Change in quality of life evaluated by SF-12 scale
Time Frame: 1 year
The SF-12 questionnaire uses 12 questions to measure functional health and well-being from the patient's point of view.
1 year
Change in quality of life evaluated by MusiQoL scale
Time Frame: 1 year
The MusiQoL (Multiple Sclerosis International Quality of Life Questionnaire) is a multidimensional Health Related Quality of Life instrument that provides information based on the views and perceptions of the participants.
1 year

Collaborators and Investigators

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

Sponsor

EDMUS Foundation

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 (Actual)

July 10, 2018

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 28, 2018

First Submitted That Met QC Criteria

July 19, 2018

First Posted (Actual)

July 27, 2018

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 002 (University of CT Health Center)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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