Serum Neurofilament-light Chain and GFAP Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis (NeurofilMS)

May 13, 2024 updated by: Centre Hospitalier Universitaire de Nīmes

Serum Neurofilament-light Chain and Glial Fibrillary Acidic Proten (GFAP) Levels in Patients From the OFSEP Cohort at Different Landmarks of Multiple Sclerosis

The investigators hypothesize that serum neurofilament-light chain (NfL) levels can provide information about the level of activity and progression of Multiple Sclerosis at different stages and landmarks of the disease.

In addition, Glial Fibrillary Acidic Protein (GFAP) has also been identified as another serum biomarker of disability in MS.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

1150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Amiens, France
      • Besançon, France
        • Not yet recruiting
        • CHU de Besancon
        • Principal Investigator:
          • Eric BERGER
        • Contact:
      • Bordeaux, France
        • Not yet recruiting
        • CHU de Bordeaux
        • Contact:
        • Sub-Investigator:
          • Aurélie RUET
        • Principal Investigator:
          • Bruno BROCHET
      • Caen, France
        • Not yet recruiting
        • CHU de Caen
        • Contact:
        • Sub-Investigator:
          • Gilles DEFER
        • Principal Investigator:
          • Nathalie DERACHE
      • Clermont-Ferrand, France
        • Not yet recruiting
        • CHU de Clermont Ferrand
        • Contact:
        • Sub-Investigator:
          • Xavier MOISSET
        • Principal Investigator:
          • Pierre CLAVELOU
        • Sub-Investigator:
          • Dominique AUFAUVRE
        • Sub-Investigator:
          • Frédéric TAITHE
      • Créteil, France
        • Not yet recruiting
        • Hopital Henri Mondor
        • Contact:
        • Principal Investigator:
          • Alain CREANGE
      • Dijon, France
        • Not yet recruiting
        • CHU de DIJON
        • Contact:
        • Sub-Investigator:
          • Agnès FROMONT
        • Sub-Investigator:
          • Dominique AUDRY
        • Sub-Investigator:
          • Gwendoline DUPONT
        • Principal Investigator:
          • Thibault MOREAU
      • Grenoble, France
        • Not yet recruiting
        • CHU de Grenoble
        • Contact:
        • Sub-Investigator:
          • Mathieu VAILLANT
        • Principal Investigator:
          • Olivier CASEZ
      • Lille, France
        • Not yet recruiting
        • CHU de Lille
        • Contact:
        • Principal Investigator:
          • Hélène ZEPHIR
      • Limoges, France
        • Not yet recruiting
        • CHU de Limoges
        • Contact:
        • Sub-Investigator:
          • Alexis MONTCUQUET
        • Principal Investigator:
          • Laurent MAGY
      • Lyon, France
        • Not yet recruiting
        • CHU de Lyon
        • Contact:
        • Sub-Investigator:
          • Françoise DURAND-DUBIEF
        • Principal Investigator:
          • Sandra VUKUSIC
      • Marseille, France
        • Not yet recruiting
        • Hôpital Timone
        • Principal Investigator:
          • Jean PELLETIER
        • Contact:
      • Montpellier, France
        • Not yet recruiting
        • CHU de Montpellier
        • Contact:
        • Sub-Investigator:
          • Xavier AYRIGNAC
        • Sub-Investigator:
          • Clarisse CARRA
        • Principal Investigator:
          • Pierre LABAUGE
      • Nancy, France
        • Not yet recruiting
        • CHU de Nancy
        • Contact:
        • Sub-Investigator:
          • Sophie PITTION VOUYOVITCH
        • Principal Investigator:
          • Marc DEBOUVERIE
      • Nice, France
        • Not yet recruiting
        • Chu de Nice
        • Contact:
        • Sub-Investigator:
          • Veronique Bourg
        • Sub-Investigator:
          • Mikaël Cohen
        • Principal Investigator:
          • Christine LEBRUN-FRENAY
      • Nîmes, France, 30029
        • Recruiting
        • CHU de Nîmes
        • Principal Investigator:
          • Eric Thouvenot, MD
        • Contact:
      • Paris, France
        • Not yet recruiting
        • Fondation Rothschild
        • Contact:
        • Sub-Investigator:
          • Romain DESCHAMPS
        • Principal Investigator:
          • Olivier GOUT
      • Paris, France
        • Not yet recruiting
        • Hopital Pitie Salpetriere
        • Contact:
        • Sub-Investigator:
          • Caroline PAPEIX
        • Principal Investigator:
          • Catherine LUBETZKI
      • Paris, France
        • Not yet recruiting
        • Hopital Saint Antoine
        • Contact:
        • Principal Investigator:
          • Bruno STANKOFF
      • Poissy, France
        • Not yet recruiting
        • CH de Poissy
        • Contact:
        • Principal Investigator:
          • Olivier HEINZLEF
      • Potiers, France
        • Not yet recruiting
        • CHU de Potiers
        • Contact:
        • Principal Investigator:
          • Jean Philippe NEAU
        • Sub-Investigator:
          • Lauriane CHAMBRIER
        • Sub-Investigator:
          • Nicolas MAUBEUGE
        • Sub-Investigator:
          • Fanny SOURDRILLE
      • Rennes, France
      • Rouen, France
        • Not yet recruiting
        • CHU de ROUEN
        • Contact:
        • Principal Investigator:
          • Bertrand BOURRE
      • Saint-Étienne, France
        • Not yet recruiting
        • CHU de Saint Etienne
        • Contact:
        • Principal Investigator:
          • Jean Philippe CAMDESSANCHE
      • Strasbourg, France
        • Not yet recruiting
        • CHU de Strasbourg
        • Contact:
        • Principal Investigator:
          • Jérôme DE SEZE
      • Toulouse, France
        • Not yet recruiting
        • CHU de Toulouse
        • Contact:
        • Principal Investigator:
          • Damien BIOTTI
        • Sub-Investigator:
          • Jonathan CIRON
      • Tours, France
        • Not yet recruiting
        • CHU de Tours
        • Contact:
        • Principal Investigator:
          • Anne-Marie GUENNOC
  • Martinique
      • Fort-de-France, Martinique
        • Not yet recruiting
        • CHU de Martinique
        • Contact:
        • Sub-Investigator:
          • Emeline Berthelot
        • Principal Investigator:
          • Philippe CABRE

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

The study population is composed of consecutive patients over 15 years of age, of both sexes, recruited during consultations for a CIS, RRMS or progressive MS at the Neurology department of 30 OFSEP centres and of Nîmes and Nantes University Hospitals. The patients recruited will have an EDSS score comprised between 0 - 7.0.

Description

Inclusion Criteria:

  • The patient has been correctly informed.
  • The patient must have given their informed and signed consent.
  • The patient must be insured or beneficiary of a health insurance plan.
  • The patient is at least (≥)15 years old.

  • The patient has MS according to diagnosis criteria (Thompson et al. 2017) and:

    • Participates to the OFSEP-HD cohort (ancillary study);
    • Has a Expanded Disability Status Scale score comprised between 0 - 7.0;
    • With or without Disease Modifying Drug;
    • For Work Package 3: patients enrolled in any OFSEP-HD centre that meet landmark criteria for an active MS (relapse, or Expanded Disability Status Scale progression, or active MRI) during follow-up;
    • For Work Package 4: patients with a stable disease enrolled in OFSEP-HD study in Nîmes or Nantes University Hospitals.

Exclusion Criteria:

  • Within the past three months, the patient has participated in another interventional study that may interfere with the results or conclusions of this study.
  • The patient is in an exclusion period determined by a previous study.
  • The patient is under judicial protection.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient (inability to understand the study, language problem).
  • The patient is pregnant or breast-feeding.
  • The patient is under 15 years old.
  • Inability to answer questionnaires.
  • Clinically isolated syndrome (CIS) that does not meet the criteria of MS.
  • Radiologically isolated syndrome (RIS).
  • Patient with Neuromyelitis optica spectrum disorder.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MS Patients
Diagnostic test: Blood sample
2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease
Time Frame: 12 months
pg/mL; measured by digital ELISA
12 months
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 12 months
pg/mL; measured by digital ELISA
12 months
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 3 years
pg/mL; measured by digital ELISA
3 years
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 4 years
pg/mL; measured by digital ELISA
4 years
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 5 years
pg/mL; measured by digital ELISA
5 years
GFAP level in patients with evolving disease compared to those with stable disease
Time Frame: 6 years
pg/mL; measured by digital ELISA
6 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
GFAP level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
GFAP level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with progressive disease measured by Expanded Disability Status Scale (1 point until 5.5 and 0.5 point after 5.5) compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
GFAP level in patients with relapse compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with relapse compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
GFAP level in patients with relapse compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with relapse compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
GFAP level in patients with relapse compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with relapse compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
GFAP level in patients with relapse compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with relapse compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
GFAP level in patients with relapse compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
GFAP level in patients with isolated MRI activity compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
GFAP level in patients with isolated MRI activity compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with isolated MRI activity compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with isolated MRI activity compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with isolated MRI activity compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 2 year
pg/mL; measured by digital ELISA
2 year
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients
Time Frame: 2 year
pg/mL; measured by digital ELISA
2 year
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with stable disease (no evidence of disease activity (NEDA) and no evidence of disease progression (NEP) from 200 patients from the OFSEP-HD cohort
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with disease activity (relapse or MRI activity)
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity)
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with disease activity (relapse, or MRI activity)
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with disease activity (relapse or MRI activity)
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with disease activity (relapse or MRI activity)
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with disease activity (relapse or MRI activity)
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with relapses
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with relapses
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with relapses
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with relapses
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with relapses
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with relapses
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with relapses
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with relapses
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with relapses
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with relapses
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with MRI activity
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with MRI activity
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with MRI activity
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with MRI activity
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with MRI activity
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with MRI activity
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with MRI activity
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with MRI activity
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with MRI activity
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with MRI activity
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 6 months
pg/mL; measured by digital ELISA
6 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 1 year
pg/mL; measured by digital ELISA
1 year
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 18 months
pg/mL; measured by digital ELISA
18 months
Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement
Time Frame: 2 years
pg/mL; measured by digital ELISA
2 years
Level of disability
Time Frame: Inclusion
Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis
Inclusion
Level of disability
Time Frame: Relapse (measured up to 2 years)
Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis
Relapse (measured up to 2 years)
Severity of multiple sclerosis
Time Frame: EDSS progression (measured up to 2 years)
Multiple Sclerosis Functional Composite
EDSS progression (measured up to 2 years)
Severity of multiple sclerosis
Time Frame: Active MRI (measured up to 2 years)
Multiple Sclerosis Functional Composite
Active MRI (measured up to 2 years)
Generic health status
Time Frame: Inclusion
EuroQol 5 dimension questionnaire (EQ-5D)
Inclusion
Generic health status
Time Frame: Relapse (measured up to 2 years)
EuroQol 5 dimension questionnaire (EQ-5D)
Relapse (measured up to 2 years)
Generic health status
Time Frame: EDSS progression (measured up to 2 years)
EuroQol 5 dimension questionnaire (EQ-5D)
EDSS progression (measured up to 2 years)
Generic health status
Time Frame: active MRI (measured up to 2 years)
EuroQol 5 dimension questionnaire (EQ-5D)
active MRI (measured up to 2 years)
Use of Disease Modifying Drugs
Time Frame: Inclusion
Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
Inclusion
Use of Disease Modifying Drugs
Time Frame: 6 monrths
Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
6 monrths
Use of Disease Modifying Drugs
Time Frame: 1 year
Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
1 year
Use of Disease Modifying Drugs
Time Frame: 18 months
Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
18 months
Use of Disease Modifying Drugs
Time Frame: 2 years
Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)
2 years
Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients
Time Frame: Month 6
pg/mL; measured by digital ELISA
Month 6
Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients
Time Frame: Month 6
pg/mL; measured by digital ELISA
Month 6
Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion
Time Frame: Inclusion
pg/mL; measured by digital ELISA
Inclusion
Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion
Time Frame: Month 6
pg/mL; measured by digital ELISA
Month 6
Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion
Time Frame: Month 6
pg/mL; measured by digital ELISA
Month 6
Create biobank
Time Frame: Inclusion
Blood samples
Inclusion
Create biobank
Time Frame: 6 months
Blood samples
6 months
Create biobank
Time Frame: 1 year
Blood samples
1 year
Create biobank
Time Frame: 18 months
Blood samples
18 months
Create biobank
Time Frame: 2 years
Blood samples
2 years
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 3 year
pg/mL; measured by digital ELISA
3 year
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 4 year
pg/mL; measured by digital ELISA
4 year
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 5 year
pg/mL; measured by digital ELISA
5 year
Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity determined by the presence of at least one T1 Gad+ lesion or at least one new T2 lesion ≤ 3 months) compared to stable patients.
Time Frame: 6 year
pg/mL; measured by digital ELISA
6 year

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nīmes

Collaborators

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Eric Thouvenot, CHU Nimes

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)

May 22, 2019

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

May 23, 2019

First Submitted That Met QC Criteria

June 7, 2019

First Posted (Actual)

June 10, 2019

Study Record Updates

Last Update Posted (Actual)

May 14, 2024

Last Update Submitted That Met QC Criteria

May 13, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIVI/2018/ET-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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