NCT03603457Active, not recruiting
OFSEP High Definition Cohort
Source: ClinicalTrials.gov · Last updated 14 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 2842 (actual)
- First submitted
- 28 Jun 2018
- Start date
- 10 Jul 2018
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- EDMUS Foundation
- Diseases
- Multiple sclerosis
- NCT number
- NCT03603457
What you commit to
- Study type: Observational
- Participants enrolled: 2842
- From 10 Jul 2018 to the primary completion date, 31 Dec 2027
- 25 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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
Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.