Clinical trial NCT03603457: OFSEP High Definition Cohort
Official title: OFSEP High Definition Cohort
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Keywords: Epidemiology
Prognostic factors
Stratified medicine
Quality of life
Economic assessment
Lead sponsor: EDMUS Foundation
Sponsor class: OTHER
First posted: 2018-07-27
Enrollment: 2842
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All MS patients from MS Clinical Reference Centre (CRC SEP).

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6
timeFrame: Through study completion, an average of 2 years
measure: Activity of disease
timeFrame: 1 year
measure: Change in T2 lesion load evaluated by analysis of raw MRI
timeFrame: 1 year
measure: Change in quality of life evaluated by EQ-5D-5L scale
timeFrame: 1 year
measure: Change in quality of life evaluated by SF-12 scale
timeFrame: 1 year
measure: Change in quality of life evaluated by MusiQoL scale
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Créteil
country: France
facility: CHU de Créteil
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHU de Lille
city: Limoges
country: France
facility: CHU de Limoges
city: Lyon
country: France
facility: CHU de Lyon
city: Montpellier
country: France
facility: CHU de Montpellier
city: Nancy
country: France
facility: CHU de Nancy
city: Nantes
country: France
facility: CHU de Nantes
city: Nice
country: France
facility: CHU de Nice
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: CHU Pitié-Salpétrière
city: Paris
country: France
facility: CHU Saint-Antoine
city: Paris
country: France
facility: Fondation Rothschild
city: Poissy
country: France
facility: CHI de Poissy-Saint-Germain-en-Laye
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rennes
country: France
facility: CHU de Rennes
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Toulouse
country: France
facility: CHU de Toulouse
city: Tours
country: France
facility: CHU de Tours
city: Fort-de-France
country: Martinique
facility: CHU de Fort-de-France
Study officials:
References: