Phenotypic and Functional Study of 4BL B Cells in Multiple Sclerosis (MS)

NCT03796611 | Completed

• 2 other identifiers: 2016_042017-A00835-48
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

Recent works highlight the B cells involvement in multiple sclerosis (MS) pathology but their role remains poorly understood. It was previously described that activated memory B cells called 4BL due to the increased expression of 4-1BBL, an activation marker, induce pro-inflammatory response by activating T CD8+ lymphocytes. Those 4BL cells are also described in systemic inflammation in 80 years old people explaining the poor efficiency of vaccination in that sub population. Those 4BL cells can also induce anti-tumoral T cell response. The hypothesize is that 4BL may induce a pathogenic inflammatory response in MS.

Conditions

Multiple Sclerosis

Keywords

immunology; B cells

Outcome Measures

Primary Outcomes (1)

• the percentage of 4 BL cells in blood between MS patients and healthy controls

  4 BL are defined using cytometric parameters

  Baseline: one session

Secondary Outcomes (3)

• the percentage of 4 BL cells in blood between MS patients and patients with inflammatory and non inflammatory neurological disease

  Baseline: one session

• the percentage of 4 BL cells in CSF between MS patients and patients with inflammatory and non inflammatory neurological disease

  Baseline: one session

• to analyse over time the evolution of 4BL percentages in blood in MS patients

  5 blood collection at baseline, 3, 6, 12, and 24 months after baseline

Other Outcomes (1)

• biological bank with mononuclear cells from all the groups fo that study

  through study completion, an average of 2 years

Study Arms (4)

multiple sclerosis patient

MS is defined according to McDonald criteria 2017. MS patients included have a disease duration of less than 1 year

other neurological inflammatory disease

autoimmune encephalitis, myasthenia gravis, chronic inflammatory demyelinating polyradiculitis

neurological non inflammatory disease

benign intracranial hypertension, degenerative disorder

healthy controls

transfusion volunteers from transfusion center

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

MS patients and controls: healthy controls and patients having non-MS neurological inflammatory disease and patients having other non inflammatory neurological disease.

You may qualify if:

• MS defined by McDonald 2017 criteria with a disease duration of less than 1 year
• between 18 and 60 years old patients
• naïve of any immune therapy or steroid intake
• patients who signed consent to the study
• patients who signed consent to the study
• between 18 and 60 years old patients
• naïve of any steroid intake or immune therapy
• control who signed consent at transfusion center for their blood collect to be used for study
• between 18 and 60 years old patients
• naïve of any steroid intake or immune therapy

You may not qualify if:

• pregnancy or breast-feeding
• patients or controls unable to sign the consent or to consent

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

chu de Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood sampling and Cerebrospinal fluid at baseline and five sequential blood sampling for MS groups

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hélène ZEPHIR, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2019
• First Posted: January 8, 2019
• Study Start: July 24, 2017
• Primary Completion: August 24, 2017
• Study Completion: August 24, 2017
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

FR (1)