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

NCT ID: NCT04964336

Last Updated: 2021-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-05

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Multiple sclerosis

Patients with relapsing-remitting multiple sclerosis

Analysis of B cells

Intervention Type OTHER

B cells from blood and cerebrospinal fluid will be analyzed using RNA-seq

Interventions

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Analysis of B cells

B cells from blood and cerebrospinal fluid will be analyzed using RNA-seq

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Andreas Lossius

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Lossius

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

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Akershus University Hospital

Lørenskog, , Norway

Site Status RECRUITING

Oslo University Hospital

Oslo, , Norway

Site Status RECRUITING

Countries

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Norway

Central Contacts

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Andreas Lossius, MD, PhD

Role: CONTACT

+47 93068515

Facility Contacts

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Trygve Holmøy, MD, PhD

Role: primary

+4767960000

Pål Berg-Hansen

Role: primary

+47 22118080

Other Identifiers

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314376 - FORSKER20

Identifier Type: -

Identifier Source: org_study_id

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