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Serum neurofilament-light chain and glial fibrillary acidic proten (GFAP) levels in patients from the OFSEP cohort at different landmarks of multiple sclerosis

NCT ID NCT03981003

Sponsor: Centre Hospitalier Universitaire de Nīmes Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 1,150 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2019

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Charcot-Marie-Tooth disease type 1F multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • CH de Poissy

    Poissy, 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

  • 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 Martinique

    Fort-de-France, Martinique

  • CHU de Montpellier

    Montpellier, France

  • CHU de Nancy

    Nancy, France

  • CHU de Nice

    Nice, France

  • CHU de Nimes

    Nîmes, 30029, France

  • CHU de Potiers

    Potiers, France

  • CHU de Rennes

    Rennes, France

  • CHU de Rouen

    Rouen, France

  • CHU de Saint Etienne

    Saint-Etienne, France

  • CHU de Strasbourg

    Strasbourg, France

  • CHU de Toulouse

    Toulouse, France

  • CHU de Tours

    Tours, France

  • Fondation Rothschild

    Paris, France

  • Hopital Henri Mondor

    Créteil, France

  • Hopital Pitie Salpetriere

    Paris, France

  • Hopital Saint Antoine

    Paris, France

  • Hopital Timone

    Marseille, France

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