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

Multiple Sclerosis Clinical Trial

— NeurofilMS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03981003
• Other study ID #: CIVI/2018/ET-02
• Status: Recruiting
• Start date: May 22, 2019
• Est. completion date: June 2028

Study information

• Verified date: May 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Eric Thouvenot
• Phone: +33.(0)4.66.68.32.61
• Email: eric.thouvenot[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1150
• Est. completion date: June 2028
• Est. primary completion date: June 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Blood sample
2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU de Besancon	Besançon
France	CHU de Bordeaux	Bordeaux
France	CHU de Caen	Caen
France	CHU de Clermont Ferrand	Clermont-Ferrand
France	Hopital Henri Mondor	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	Hopital Timone	Marseille
France	CHU de Montpellier	Montpellier
France	CHU de Nancy	Nancy
France	CHU de Nice	Nice
France	CHU de Nimes	Nîmes
France	Fondation Rothschild	Paris
France	Hopital Pitie Salpetriere	Paris
France	Hopital Saint Antoine	Paris
France	CH de Poissy	Poissy
France	CHU de Potiers	Potiers
France	CHU de Rennes	Rennes
France	CHU de Rouen	Rouen
France	CHU de Saint Etienne	Saint-Étienne
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse
France	CHU de Tours	Tours
Martinique	CHU de Martinique	Fort-de-France

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes	Hospices Civils de Lyon

Countries where clinical trial is conducted

France,  Martinique, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	Inclusion
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	Inclusion
Primary	Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	6 months
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	6 months
Primary	Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	12 months
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	12 months
Primary	Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	18 months
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	18 months
Primary	Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	2 years
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	3 years
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	4 years
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	5 years
Primary	GFAP level in patients with evolving disease compared to those with stable disease	pg/mL; measured by digital ELISA	6 years
Secondary	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.	pg/mL; measured by digital ELISA	Inclusion
Secondary	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.	pg/mL; measured by digital ELISA	Inclusion
Secondary	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.	pg/mL; measured by digital ELISA	6 months
Secondary	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.	pg/mL; measured by digital ELISA	6 months
Secondary	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.	pg/mL; measured by digital ELISA	1 year
Secondary	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.	pg/mL; measured by digital ELISA	3 year
Secondary	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.	pg/mL; measured by digital ELISA	4 year
Secondary	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.	pg/mL; measured by digital ELISA	5 year
Secondary	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.	pg/mL; measured by digital ELISA	6 year
Secondary	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.	pg/mL; measured by digital ELISA	1 year
Secondary	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.	pg/mL; measured by digital ELISA	18 months
Secondary	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.	pg/mL; measured by digital ELISA	18 months
Secondary	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.	pg/mL; measured by digital ELISA	2 years
Secondary	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.	pg/mL; measured by digital ELISA	2 years
Secondary	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	pg/mL; measured by digital ELISA	Inclusion
Secondary	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	pg/mL; measured by digital ELISA	Inclusion
Secondary	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	pg/mL; measured by digital ELISA	6 months
Secondary	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	pg/mL; measured by digital ELISA	6 months
Secondary	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	pg/mL; measured by digital ELISA	1 year
Secondary	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	pg/mL; measured by digital ELISA	1 year
Secondary	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	pg/mL; measured by digital ELISA	18 months
Secondary	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	pg/mL; measured by digital ELISA	18 months
Secondary	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	pg/mL; measured by digital ELISA	2 years
Secondary	GFAP level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	GFAP level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	GFAP level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	GFAP level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	2 years
Secondary	GFAP level in patients with relapse compared to stable patients	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	GFAP level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	GFAP level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with isolated MRI activity compared to stable patients	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	2 year
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	2 year
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients	pg/mL; measured by digital ELISA	2 years
Secondary	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	pg/mL; measured by digital ELISA	Inclusion
Secondary	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	pg/mL; measured by digital ELISA	Inclusion
Secondary	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	pg/mL; measured by digital ELISA	6 months
Secondary	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	pg/mL; measured by digital ELISA	6 months
Secondary	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	pg/mL; measured by digital ELISA	1 year
Secondary	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	pg/mL; measured by digital ELISA	1 year
Secondary	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	pg/mL; measured by digital ELISA	18 months
Secondary	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	pg/mL; measured by digital ELISA	18 months
Secondary	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	pg/mL; measured by digital ELISA	2 years
Secondary	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	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in progressive MS patients with no evidence of disease progression (NEP) from the OFSEP-HD cohort with stable disease	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity)	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with disease activity (relapse, or MRI activity)	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with disease activity (relapse or MRI activity)	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with relapses	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with relapses	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with relapses	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with relapses	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with relapses	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with relapses	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with relapses	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with relapses	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with relapses	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with relapses	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with MRI activity	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with MRI activity	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with MRI activity	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with MRI activity	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with MRI activity	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with MRI activity	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with MRI activity	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with MRI activity	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with MRI activity	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with MRI activity	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement	pg/mL; measured by digital ELISA	2 years
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	6 months
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	6 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	1 year
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	1 year
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	18 months
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	18 months
Secondary	Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	2 years
Secondary	Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement	pg/mL; measured by digital ELISA	2 years
Secondary	Level of disability	Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis	Inclusion
Secondary	Level of disability	Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis	Relapse (measured up to 2 years)
Secondary	Severity of multiple sclerosis	Multiple Sclerosis Functional Composite	EDSS progression (measured up to 2 years)
Secondary	Severity of multiple sclerosis	Multiple Sclerosis Functional Composite	Active MRI (measured up to 2 years)
Secondary	Generic health status	EuroQol 5 dimension questionnaire (EQ-5D)	Inclusion
Secondary	Generic health status	EuroQol 5 dimension questionnaire (EQ-5D)	Relapse (measured up to 2 years)
Secondary	Generic health status	EuroQol 5 dimension questionnaire (EQ-5D)	EDSS progression (measured up to 2 years)
Secondary	Generic health status	EuroQol 5 dimension questionnaire (EQ-5D)	active MRI (measured up to 2 years)
Secondary	Use of Disease Modifying Drugs	Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)	Inclusion
Secondary	Use of Disease Modifying Drugs	Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)	6 monrths
Secondary	Use of Disease Modifying Drugs	Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)	1 year
Secondary	Use of Disease Modifying Drugs	Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)	18 months
Secondary	Use of Disease Modifying Drugs	Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)	2 years
Secondary	Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients	pg/mL; measured by digital ELISA	Month 6
Secondary	Serum GFAP in 800 patients from the OFSEP cohort including Multiple Sclerosis patients at different stages and Neuromyelitis optica spectrum disorder patients	pg/mL; measured by digital ELISA	Month 6
Secondary	Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion	pg/mL; measured by digital ELISA	Inclusion
Secondary	Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion	pg/mL; measured by digital ELISA	Month 6
Secondary	Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion	pg/mL; measured by digital ELISA	Month 6
Secondary	Create biobank	Blood samples	Inclusion
Secondary	Create biobank	Blood samples	6 months
Secondary	Create biobank	Blood samples	1 year
Secondary	Create biobank	Blood samples	18 months
Secondary	Create biobank	Blood samples	2 years