Analysis of the Distribution of Regulatory B Cells in Blood of Multiple Sclerosis Patients

NCT02789670 | Completed

• 2 other identifiers: 2013_352014-A00248-39
• Study Type: observational
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

New therapeutic approaches of MS are emerging, targeting different actors of the immune system. Some of them target a specific population of white blood cells: B lymphocytes composed of different subpopulations. The subsets of B cells express different functional properties that control the immune response, but these regulation mechanisms have yet to be clearly described. Some subpopulations could amplify inflammation through IL-6 production for example, whereas some ones contribute to its regulation through the production of IL-10. Using samples collected in a large cohort of individuals with risk of MS and treatment-naive patients in the early onset of the disease, the investigators aim to develop a 2 year follow-up study of the different blood B cells subset distribution and their functional properties in terms of pro- and anti-inflammatory cytokine production in MS. This approach can identify new biomarkers for monitoring of MS patients and lead to better define the indication use of depletive B cell drugs and not to counteract the regulatory action of these cells.

Conditions

Multiple Sclerosis; Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

• Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at inclusion time point

  Percentage of B cells expressing intracellular IL-6 and/or IL-10 will be analyzed in MS patients versus controls at inclusion

  inclusion

Secondary Outcomes (7)

• Comparison of the production of IL-10 and IL-6 by B cells in MS patients and the control group at the different time points of the study

  3, 6, 12, 24 months

• Comparison of the production of IL-10 and IL-6 by B cells in the MS patient subgroups at the inclusion time point

  inclusion

• Comparison of the production of IL-10 and IL-6 by B cells in the MS patient subgroups at the different time points of the study

  3, 6, 12, 24 months

• Comparison B cell subset distribution in MS patients and the control group

  at inclusion

• Comparison B cell subset distribution

  at inclusion

Study Arms (2)

MS patients

MS patient group is composed by 20 Individuals with inflammatory brain lesions seen in MRI (Radiologically Isolated syndrome) 20 patients with only one clinically isolated syndrome (CIS) 20 patients with relapsed remittent Multiple sclerosis (RRMS) 20 patients with primary progressive Multiple Sclerosis (PPMS)

Other: Blood sample collection

Control group patients

Control patient cohort is composed by 20 patients suffering from inflammatory neurological disease other than MS Devic syndrome, Neurosarcoidosis, Neurobehcet... (autoimmune disease control group with neurological disease) 20 patients with systemic sclerosis (autoimmune disease control group) without neurological disease) 40 healthy subjects

Other: Blood sample collection

Interventions

Blood sample collection OTHER

Peripheral blood will be collected in patients at the different time of the study to analyze phenotypic and functional properties of B cells in MS patients and control group

Control group patients; MS patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary care clinic

You may qualify if:

• Patients with MS criteria (McDonald et al. 2001) or with Clinically isolated syndrome (CIS) or radiologically isolated syndrome(RIS) or
• Patients patients with other neurological inflammatory disease (OIND) or with autoimmune disease without neurological disease Leroy Metsger' criteria of systemic sclerosis) (OID)

You may not qualify if:

• Women without reliable contraception
• Nursing women
• Patients having immunosuppressive treatment in the last month ( beta interféron, glatiramer acetate, natalizumab, fingolimod, glucocorticoid)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

CHRU de Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples to collect peripheral blood mononuclear cells Phenotypic and functional studies using flow cytometric approaches

MeSH Terms

Conditions

Multiple Sclerosis; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Sylvain DUBUCQUOI, MD PhD

  CHRU de LILLE

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 12, 2016
• First Posted: June 3, 2016
• Study Start: July 1, 2014
• Primary Completion: April 1, 2021
• Study Completion: April 1, 2021
• Last Updated: October 14, 2022

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)