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Completed

NCT Number: NCT03796611

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

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

chu de Lille

Lille, France

About this study

the aim to compare the proportion of peripheral (blood) 4 BL cells but also 4-BL cells in cerebro spinal fluid (CSF) in MS compared to healthy controls and to other inflammatory neurological disease but also non inflammatory neurological disease.

For all groups of patients and controls it will collect blood and CSF only once (at diagnosis time for patients).

Blood collect from healthy controls will come from transfusion volunteers and we won't have CSF from them.

For patients from the MS group, the blood collect will be sequential at diagnosis, 3, 6, 12 and 24 months after during the follow up.

In the blood and CSF we will evaluate:

  • percentage of 4 BL cells. 4 BL cells are found using cytometric parameters
  • capacity of 4 BL cells to induce inflammatory response in vitro: percentage of induced activated TCD8 proliferation after cell culture using extracellular and intracellular cytometric parameters

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

for MS group:

  • 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

Inclusion criteria

for controls with inflammatory of non inflammatory neurological disease:

  • patients who signed consent to the study
  • between 18 and 60 years old patients
  • naïve of any steroid intake or immune therapy

Inclusion criteria

for healthy controls:

  • 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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

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

    Time frame: Baseline: one session

    4 BL are defined using cytometric parameters

Secondary outcomes

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

    Time frame: Baseline: one session

    4 BL are defined using cytometric parameters

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

    Time frame: Baseline: one session

    4 BL are defined using cytometric parameters

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

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

    4 BL are defined using cytometric parameters

Other outcomes

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

    Time frame: through study completion, an average of 2 years

    to constitute at Baseline a biological bank with mononuclear cells from all the groups fo that study

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: 4BLMS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 8, 2019
Registry last updated
May 5, 2026

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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