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OFSEP High Definition Cohort (OFSEP HD)

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ClinicalTrials.gov Identifier: NCT03603457
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
EDMUS Foundation

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.


Condition or disease
Multiple Sclerosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: OFSEP High Definition Cohort
Actual Study Start Date : July 10, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Time to reach irreversible Expanded Disability Status Scale (EDSS) scores of 6 [ Time Frame: Through study completion, an average of 2 years ]
  2. 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)

  3. Change in T2 lesion load evaluated by analysis of raw MRI [ Time Frame: 1 year ]
  4. 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.


  5. 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.

  6. 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.


Biospecimen Retention:   Samples With DNA
blood, serum


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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All MS patients from MS Clinical Reference Centre (CRC SEP).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03603457


Contacts
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Contact: Sandra Vukusic 33 4 72 35 73 42 sandra.vukusic@chu-lyon.fr
Contact: Francis Guillemin 33 3 83 85 21 65 francis.guillemin@chru-nancy.fr

Locations
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France
CHU d'Amiens Not yet recruiting
Amiens, France
Contact: Abdullatif AL KHEDR         
CHU de Besançon Not yet recruiting
Besançon, France
Contact: Eric BERGER         
CHU de Bordeaux Not yet recruiting
Bordeaux, France
Contact: Bruno BROCHET         
CHU de Caen Not yet recruiting
Caen, France
Contact: Gilles DEFER         
CHU de Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France
Contact: Pierre CLAVELOU         
CHU de Créteil Not yet recruiting
Créteil, France
Contact: Alain CREANGE         
CHU de Dijon Not yet recruiting
Dijon, France
Contact: Thibaulth MOREAU         
CHU de Grenoble Not yet recruiting
Grenoble, France
Contact: Olivier CASEZ         
CHU de Lille Not yet recruiting
Lille, France
Contact: Patrick VERMERSCH         
CHU de Limoges Not yet recruiting
Limoges, France
Contact: Laurent MAGY         
CHU de Lyon Recruiting
Lyon, France
Contact: Sandra VUKUSIC         
CHU de Marseille Recruiting
Marseille, France
Contact: Jean PELLETIER         
CHU de Montpellier Not yet recruiting
Montpellier, France
Contact: Pierre LABAUGE         
CHU de Nancy Not yet recruiting
Nancy, France
Contact: Marc DEBOUVERIE         
CHU de Nantes Not yet recruiting
Nantes, France
Contact: David LAPLAUD         
CHU de Nice Not yet recruiting
Nice, France
Contact: Christine LEBRUN-FRENAY         
CHU de Nîmes Not yet recruiting
Nîmes, France
Contact: Eric THOUVENOT         
CHU Pitié-Salpétrière Not yet recruiting
Paris, France
Contact: Catherine LUBETZKI         
CHU Saint-Antoine Not yet recruiting
Paris, France
Contact: Bruno STANKOFF         
Fondation Rothschild Not yet recruiting
Paris, France
Contact: Olivier GOUT         
CHI de Poissy-Saint-Germain-en-Laye Not yet recruiting
Poissy, France
Contact: Olivier HEINZLEF         
CHU de Poitiers Not yet recruiting
Poitiers, France
Contact: Jean-Philippe NEAU         
CHU de Reims Not yet recruiting
Reims, France
Contact: Ayman TOURBAH         
CHU de Rennes Not yet recruiting
Rennes, France
Contact: Gilles EDAN         
CHU de Rouen Not yet recruiting
Rouen, France
Contact: Bertrand BOURRE         
CHU de Saint-Etienne Not yet recruiting
Saint-Étienne, France
Contact: Jean-Philippe CAMDESSANCHE         
CHU de Strasbourg Not yet recruiting
Strasbourg, France
Contact: Jérôme DE SEZE         
CHU de Toulouse Not yet recruiting
Toulouse, France
Contact: David BRASSAT         
CHU de Tours Not yet recruiting
Tours, France
Contact: Anne-Marie GUENNOC         
Martinique
CHU de Fort-de-France Not yet recruiting
Fort-de-France, Martinique
Contact: Philippe CABRE         
Sponsors and Collaborators
EDMUS Foundation

Additional Information:

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Responsible Party: EDMUS Foundation
ClinicalTrials.gov Identifier: NCT03603457     History of Changes
Other Study ID Numbers: 002
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
URL: http://www.ofsep.org/en/data-access

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by EDMUS Foundation:
Epidemiology
Prognostic factors
Stratified medicine
Quality of life
Economic assessment

Additional relevant MeSH terms:
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Multiple Sclerosis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases