An Observational Study to Investigate the Role of B Cells in Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Other: Analysis of B cells

• Registration Number: NCT04964336
• Lead Sponsor: University of Oslo

Brief Summary

Multiple sclerosis (MS) typically afflict young people in their twenties, when they start a career and establish a family. The disease thus imposes a severe impact on quality of life and heavy economic burdens on society. Critical barriers to progress in the field are the lack of knowledge of relevant immune cell subsets driving the pathology and the targets of the immune response within the central nervous system. In this project, we will test the hypothesis that a subgroup of MS patients is defined by a genetically determined B cell response against specific antigenic epitopes. The hypothesis is based on our recent, pioneering results showing that approximately half of MS patients have a restricted population of B cells in the cerebrospinal fluid defined by polymorphisms in the constant heavy-chain of the immunoglobulin B cell receptor, the G1m1 allotype. Here, we aim to characterize the G1m1 B cells, to disentangle the genetic basis of the B cell response, and to identify the molecular targets.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-05
• Status Verified: 2021-07
• Study First Submitted: 2021-07-07
• Study First Submitted QC: 2021-07-15
• Last Update Submitted: 2021-07-15
• Study First Posted: 2021-07-16
• Last Update Posted: 2021-07-16
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Symptoms and brain MRI scans strongly suggestive of multiple sclerosis according to the 2017 McDonald revisions
• Intrathecal immunoglobulin G synthesis
• Age > 18 years

Exclusion Criteria

• Treatment with immunomodulatory drugs

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Multiple sclerosis	Analysis of B cells	Patients with relapsing-remitting multiple sclerosis

Primary Outcome Measures

Name	Time	Method
The transcriptome of B cells from blood and cerebrospinal fluid	1 day (subject inclusion)
The immunglobulin receptors of B cells from blood and cerebrospinal fluid	1 day (subject inclusion)

Trial Locations

Locations (2)

Akershus University Hospital; 🇳🇴 Lørenskog, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway