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NCT Number: NCT03981003

Serum Neurofilament-light Chain and 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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Charcot-Marie-Tooth disease, Type 1F Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Amiens, Amiens, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Diagnostic Test

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

Primary outcomes

  1. 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

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  3. 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

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  5. 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

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

    Time frame: 12 months

    pg/mL; measured by digital ELISA

  7. 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

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  9. 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

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

    Time frame: 3 years

    pg/mL; measured by digital ELISA

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

    Time frame: 4 years

    pg/mL; measured by digital ELISA

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

    Time frame: 5 years

    pg/mL; measured by digital ELISA

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

    Time frame: 6 years

    pg/mL; measured by digital ELISA

Secondary outcomes

  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.

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  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.

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  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.

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  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.

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  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.

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  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.

    Time frame: 3 year

    pg/mL; measured by digital ELISA

  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.

    Time frame: 4 year

    pg/mL; measured by digital ELISA

  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.

    Time frame: 5 year

    pg/mL; measured by digital ELISA

  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.

    Time frame: 6 year

    pg/mL; measured by digital ELISA

  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.

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  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.

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  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.

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  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.

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  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.

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  35. 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

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  37. 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

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  39. 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

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  41. 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

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  74. 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

  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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  76. 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

  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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  78. 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

  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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  80. 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

  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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  82. 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

  83. 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

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  85. 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

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  87. 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

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  89. 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

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  91. 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

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  103. Serum Neurofilament Light Chain level in patients with relapses

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  104. Serum GFAP level in patients with relapses

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  105. Serum Neurofilament Light Chain level in patients with relapses

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  106. Serum GFAP level in patients with relapses

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  107. Serum Neurofilament Light Chain level in patients with relapses

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  108. Serum GFAP level in patients with relapses

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  109. Serum Neurofilament Light Chain level in patients with relapses

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  110. Serum GFAP level in patients with relapses

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  111. Serum Neurofilament Light Chain level in patients with relapses

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  112. Serum GFAP level in patients with relapses

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  114. Serum GFAP level in patients with MRI activity

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

  116. Serum GFAP level in patients with MRI activity

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

  118. Serum GFAP level in patients with MRI activity

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

  120. Serum GFAP level in patients with MRI activity

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  122. Serum GFAP level in patients with MRI activity

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 6 months

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 1 year

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 18 months

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

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

    Time frame: 2 years

    pg/mL; measured by digital ELISA

  143. Level of disability

    Time frame: Inclusion

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

  144. 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

  145. Severity of multiple sclerosis

    Time frame: EDSS progression (measured up to 2 years)

    Multiple Sclerosis Functional Composite

  146. Severity of multiple sclerosis

    Time frame: Active MRI (measured up to 2 years)

    Multiple Sclerosis Functional Composite

  147. Generic health status

    Time frame: Inclusion

    EuroQol 5 dimension questionnaire (EQ-5D)

  148. Generic health status

    Time frame: Relapse (measured up to 2 years)

    EuroQol 5 dimension questionnaire (EQ-5D)

  149. Generic health status

    Time frame: EDSS progression (measured up to 2 years)

    EuroQol 5 dimension questionnaire (EQ-5D)

  150. Generic health status

    Time frame: active MRI (measured up to 2 years)

    EuroQol 5 dimension questionnaire (EQ-5D)

  151. Use of Disease Modifying Drugs

    Time frame: Inclusion

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

  152. Use of Disease Modifying Drugs

    Time frame: 6 monrths

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

  153. Use of Disease Modifying Drugs

    Time frame: 1 year

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

  154. Use of Disease Modifying Drugs

    Time frame: 18 months

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

  155. Use of Disease Modifying Drugs

    Time frame: 2 years

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

  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

    Time frame: Inclusion

    pg/mL; measured by digital ELISA

  157. 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

  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

    Time frame: Month 6

    pg/mL; measured by digital ELISA

  159. 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

  160. 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

  161. 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

  162. 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

  163. 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

  164. Create biobank

    Time frame: Inclusion

    Blood samples

  165. Create biobank

    Time frame: 6 months

    Blood samples

  166. Create biobank

    Time frame: 1 year

    Blood samples

  167. Create biobank

    Time frame: 18 months

    Blood samples

  168. Create biobank

    Time frame: 2 years

    Blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Eric Thouvenot

CONTACT

[email protected]

+33.(0)4.66.68.32.61

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Collaborators

  • Hospices Civils de Lyon

Registry information

Official study title

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

Acronym: NeurofilMS

Important dates

Study start
2019
Primary completion
2028
Study completion
2028
First posted
Jun 10, 2019
Registry last updated
May 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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