NCT04202055

Brief Summary

The aim of this study was the describe the Immunologic biomarker profile of cerebrospinal fluid in multiple sclerosis patients

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
165

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
Last Updated

December 17, 2019

Status Verified

December 1, 2019

Enrollment Period

1.7 years

First QC Date

December 16, 2019

Last Update Submit

December 16, 2019

Conditions

Multiple SclerosisNeuromyelitis Optica

Outcome Measures

Primary Outcomes (14)

  • Level of glial fibrillar acidic protein in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of chitinase-3-like protein 1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of neurofilament in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Interleukin-6 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Interleukin-8 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of C-X-C motif ligand (CXCL-13) in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Matrix metalloproteinase-9 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Soluble CD27 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Interleukin 10 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Interleukin 17A in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of Interleukin 1B in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of monocyte chemoattractant protein-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of soluble intercellular adhesion molecule-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

  • Level of soluble vascular cell adhesion molecule-1 in cerebrospinal fluid in patients with Neuromyelitis Optica with anti- Myelin Oligodendrocyte Glycoprotein

    enzyme-linked immunosorbent assay

    Baseline

Secondary Outcomes (14)

  • Level of glial fibrillar acidic protein in cerebrospinal fluid in each group

    Baseline

  • Level of chitinase-3-like protein 1 in cerebrospinal fluid in each group

    Baseline

  • Level of neurofilament in cerebrospinal fluid in each group

    Baseline

  • Level of Interleukin-6 in cerebrospinal fluid in each group

    Baseline

  • Level of Interleukin-8 in cerebrospinal fluid in each group

    Baseline

  • +9 more secondary outcomes

Study Arms (6)

Neuromyelitis optica with anti-MOG

Other: Biomarker analysis

Patients with Neuromyelitis optica with anti-AQP4

Other: Biomarker analysis

Seronegative patients with Neuromyelitis optica

Other: Biomarker analysis

Patients with recurrent-remitting multiple sclerosis

Patients with recurrent-remitting multiple sclerosis with medullary or optic involvement

Other: Biomarker analysis

Progressive multiple sclerosis patients

Other: Biomarker analysis

Symptomatic controls

Other: Biomarker analysis

Interventions

Biomarker analysisOTHER

Detection of biomarker in cerebrospinal fluid

Neuromyelitis optica with anti-MOGPatients with Neuromyelitis optica with anti-AQP4Patients with recurrent-remitting multiple sclerosisProgressive multiple sclerosis patientsSeronegative patients with Neuromyelitis opticaSymptomatic controls

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Samples stored from the NOMADMUS cohort in the OFSEP collection and the NEURO collection from the Centre de Collections Biologiques Hospitalières

You may qualify if:

  • patients who have had neuromyelitis ptica with anti-AQP4 antibodies, or anti- Myelin Oligodendrocyte Glycoprotein antibodies, or double seronegative antibodies.
  • Neuromyelitis Optica patients have been prospectively included in the OFSEP collection
  • Multiple sclerosis patients, isolated myelitis or optic neuritis patients, and symptomatic controls whose samples will come from the "NEURO" collection of the Hospital Biological Collections Center,
  • Patients have given their free consent for use of their samples in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nimes

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Multiple SclerosisNeuromyelitis Optica

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesMyelitis, TransverseOptic NeuritisOptic Nerve DiseasesCranial Nerve DiseasesEye Diseases

Study Officials

  • Eric Thouvenot

    CHU Nimes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2019

First Posted

December 17, 2019

Study Start

January 2, 2018

Primary Completion

August 31, 2019

Study Completion

August 31, 2019

Last Updated

December 17, 2019

Record last verified: 2019-12

Locations

FR(1)