AzTrials
AzTrials

Multiple SclerosisNeurofilMSNCT03981003

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

An observational study of Multiple Sclerosis, run by Centre Hospitalier Universitaire de Nīmes at 28 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Blood sample
How many people
1,150 participants
Where
28 sitesin 2 countries
Study dates
22 May 2019to Jun 2027
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

Who may be able to join

  • 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);
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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.

Trial locations and contacts

28 sites in 2 countries.

28 sites in 2 countries

France27 sites

  • CHU d'Amiens

    Amiens

  • CHU de Besancon

    Besançon

  • CHU de Bordeaux

    Bordeaux

  • CHU de Caen

    Caen

  • CHU de Clermont Ferrand

    Clermont-Ferrand

  • Hopital Henri Mondor

    Créteil

  • CHU de Dijon

    Dijon

  • CHU de Grenoble

    Grenoble

  • CHU de Lille

    Lille

  • CHU de Limoges

    Limoges

  • CHU de Lyon

    Lyon

  • Hopital Timone

    Marseille

  • CHU de Montpellier

    Montpellier

  • CHU de Nancy

    Nancy

  • CHU de Nice

    Nice

  • CHU de Nimes

    Nîmes, 30029

  • Fondation Rothschild

    Paris

  • Hopital Pitie Salpetriere

    Paris

  • Hopital Saint Antoine

    Paris

  • CH de Poissy

    Poissy

  • CHU de Potiers

    Potiers

  • CHU de Rennes

    Rennes

  • CHU de Rouen

    Rouen

  • CHU de Saint Etienne

    Saint-Etienne

  • CHU de Strasbourg

    Strasbourg

  • CHU de Toulouse

    Toulouse

  • CHU de Tours

    Tours

Other trials in France

Martinique1 site

  • CHU de Martinique

    Fort-de-France

Other trials in Martinique

About this study

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

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.

Being tested
Blood sample
Keywords
Neurofilament-light chain, Glial fibrillary Acidic Protein (GFAP)
Medical subject headings
Multiple Sclerosis, Charcot-Marie-Tooth disease, Type 1F

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleDiagnostic test

    2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels

Study groups in NCT03981003
Study groupRoleWhat they receive
MS PatientsNot described
Receives: Diagnostic Test: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  2. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  3. Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 6 months

  4. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 6 months

  5. Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 12 months

  6. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 12 months

  7. Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 18 months

  8. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 18 months

  9. Serum Neurofilament Light Chain level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 2 years

  10. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 3 years

  11. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 4 years

  12. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 5 years

  13. GFAP level in patients with evolving disease compared to those with stable disease

    pg/mL; measured by digital ELISA

    Measured: 6 years

Secondary outcomes (168)

  1. 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

    Measured: Inclusion

  2. 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

    Measured: Inclusion

  3. 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

    Measured: 6 months

  4. 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

    Measured: 6 months

  5. 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

    Measured: 1 year

  6. 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

    Measured: 3 year

  7. 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

    Measured: 4 year

  8. 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

    Measured: 5 year

  9. 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

    Measured: 6 year

  10. 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

    Measured: 1 year

  11. 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

    Measured: 18 months

  12. 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

    Measured: 18 months

  13. 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

    Measured: 2 years

  14. 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

    Measured: 2 years

  15. 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

    Measured: Inclusion

  16. 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

    Measured: Inclusion

  17. 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

    Measured: 6 months

  18. 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

    Measured: 6 months

  19. 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

    Measured: 1 year

  20. 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

    Measured: 1 year

  21. 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

    Measured: 18 months

  22. 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

    Measured: 18 months

  23. 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

    Measured: 2 years

  24. GFAP level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  25. Serum Neurofilament Light Chain level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  26. GFAP level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  27. Serum Neurofilament Light Chain level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  28. GFAP level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  29. Serum Neurofilament Light Chain level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  30. GFAP level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  31. Serum Neurofilament Light Chain level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 years

  32. GFAP level in patients with relapse compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 years

  33. Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  34. GFAP level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  35. Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  36. GFAP level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  37. Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  38. Serum GFAP level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  39. Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  40. Serum GFAP level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  41. Serum Neurofilament Light Chain level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 years

  42. Serum GFAP level in patients with isolated MRI activity compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 years

  43. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  44. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  45. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  46. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  47. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  48. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  49. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  50. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  51. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 year

  52. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 year

  53. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  54. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  55. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  56. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 6 months

  57. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  58. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 1 year

  59. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  60. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 18 months

  61. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 years

  62. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement compared to stable patients

    pg/mL; measured by digital ELISA

    Measured: 2 years

  63. 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

    Measured: Inclusion

  64. 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

    Measured: Inclusion

  65. 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

    Measured: 6 months

  66. 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

    Measured: 6 months

  67. 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

    Measured: 1 year

  68. 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

    Measured: 1 year

  69. 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

    Measured: 18 months

  70. 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

    Measured: 18 months

  71. 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

    Measured: 2 years

  72. 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

    Measured: 2 years

  73. 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

    Measured: Inclusion

  74. 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

    Measured: Inclusion

  75. 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

    Measured: 6 months

  76. 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

    Measured: 6 months

  77. 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

    Measured: 1 year

  78. 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

    Measured: 1 year

  79. 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

    Measured: 18 months

  80. 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

    Measured: 18 months

  81. 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

    Measured: 2 years

  82. 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

    Measured: 2 years

  83. Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  84. Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  85. Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 6 months

  86. Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 6 months

  87. Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 1 year

  88. Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 1 year

  89. Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 18 months

  90. Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 18 months

  91. Serum Neurofilament Light Chain level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 2 years

  92. Serum GFAP level in patients with disease evolution (relapse, disability progression or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 2 years

  93. Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  94. Serum GFAP level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  95. Serum Neurofilament Light Chain level in patients with disease activity (relapse, or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 6 months

  96. Serum GFAP level in patients with disease activity (relapse, or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 6 months

  97. Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 1 year

  98. Serum GFAP level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 1 year

  99. Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 18 months

  100. Serum GFAP level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 18 months

  101. Serum Neurofilament Light Chain level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 2 years

  102. Serum GFAP level in patients with disease activity (relapse or MRI activity)

    pg/mL; measured by digital ELISA

    Measured: 2 years

  103. Serum Neurofilament Light Chain level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  104. Serum GFAP level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  105. Serum Neurofilament Light Chain level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 6 months

  106. Serum GFAP level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 6 months

  107. Serum Neurofilament Light Chain level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 1 year

  108. Serum GFAP level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 1 year

  109. Serum Neurofilament Light Chain level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 18 months

  110. Serum GFAP level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 18 months

  111. Serum Neurofilament Light Chain level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 2 years

  112. Serum GFAP level in patients with relapses

    pg/mL; measured by digital ELISA

    Measured: 2 years

  113. Serum Neurofilament Light Chain level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  114. Serum GFAP level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  115. Serum Neurofilament Light Chain level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 6 months

  116. Serum GFAP level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 6 months

  117. Serum Neurofilament Light Chain level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 1 year

  118. Serum GFAP level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 1 year

  119. Serum Neurofilament Light Chain level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 18 months

  120. Serum GFAP level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 18 months

  121. Serum Neurofilament Light Chain level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 2 years

  122. Serum GFAP level in patients with MRI activity

    pg/mL; measured by digital ELISA

    Measured: 2 years

  123. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  124. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  125. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 6 months

  126. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 6 months

  127. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 1 year

  128. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 1 year

  129. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 18 months

  130. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 18 months

  131. Serum Neurofilament Light Chain level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 2 years

  132. Serum GFAP level in patients with isolated MRI activity and Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 2 years

  133. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  134. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  135. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 6 months

  136. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 6 months

  137. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 1 year

  138. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 1 year

  139. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 18 months

  140. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 18 months

  141. Serum Neurofilament Light Chain level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 2 years

  142. Serum GFAP level in patients with isolated MRI activity without Gadolinium-enhancement

    pg/mL; measured by digital ELISA

    Measured: 2 years

  143. Level of disability

    Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis

    Measured: Inclusion

  144. Level of disability

    Expanded Disability Status Scale (EDSS); scale 1= no disability to 10 = death from multiple sclerosis

    Measured: Relapse (measured up to 2 years)

  145. Severity of multiple sclerosis

    Multiple Sclerosis Functional Composite

    Measured: EDSS progression (measured up to 2 years)

  146. Severity of multiple sclerosis

    Multiple Sclerosis Functional Composite

    Measured: Active MRI (measured up to 2 years)

  147. Generic health status

    EuroQol 5 dimension questionnaire (EQ-5D)

    Measured: Inclusion

  148. Generic health status

    EuroQol 5 dimension questionnaire (EQ-5D)

    Measured: Relapse (measured up to 2 years)

  149. Generic health status

    EuroQol 5 dimension questionnaire (EQ-5D)

    Measured: EDSS progression (measured up to 2 years)

  150. Generic health status

    EuroQol 5 dimension questionnaire (EQ-5D)

    Measured: active MRI (measured up to 2 years)

  151. Use of Disease Modifying Drugs

    Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)

    Measured: Inclusion

  152. Use of Disease Modifying Drugs

    Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)

    Measured: 6 monrths

  153. Use of Disease Modifying Drugs

    Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)

    Measured: 1 year

  154. Use of Disease Modifying Drugs

    Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)

    Measured: 18 months

  155. Use of Disease Modifying Drugs

    Categorized by class type of treatment (1st line, 2nd line and 3rd line therapies)

    Measured: 2 years

  156. 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

    Measured: Inclusion

  157. 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

    Measured: Inclusion

  158. 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

    Measured: Month 6

  159. 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

    Measured: Month 6

  160. Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  161. Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion

    pg/mL; measured by digital ELISA

    Measured: Inclusion

  162. Serum Neurofilament Light Chain in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion

    pg/mL; measured by digital ELISA

    Measured: Month 6

  163. Serum GFAP in 400 patients from the OFSEP cohort with a Clinically Isolated Syndrome at inclusion

    pg/mL; measured by digital ELISA

    Measured: Month 6

  164. Create biobank

    Blood samples

    Measured: Inclusion

  165. Create biobank

    Blood samples

    Measured: 6 months

  166. Create biobank

    Blood samples

    Measured: 1 year

  167. Create biobank

    Blood samples

    Measured: 18 months

  168. Create biobank

    Blood samples

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jun 2019
  2. Study start22 May 2019
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
1,150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03981003
Sponsor's protocol ID
CIVI/2018/ET-02
Acronym
NeurofilMS
Status last verified
Oct 2026
First submitted
23 May 2019
Last updated
21 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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