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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03603457
Other study ID # 002
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 10, 2018
Est. completion date December 2026

Study information

Verified date August 2023
Source EDMUS Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 2900
Est. completion date December 2026
Est. primary completion date December 2026
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
EDMUS Foundation

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6 Through study completion, an average of 2 years
Primary Activity of disease 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
Primary Change in T2 lesion load evaluated by analysis of raw MRI 1 year
Primary Change in quality of life evaluated by EQ-5D-5L scale 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
Primary Change in quality of life evaluated by SF-12 scale The SF-12 questionnaire uses 12 questions to measure functional health and well-being from the patient's point of view. 1 year
Primary Change in quality of life evaluated by MusiQoL scale 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
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