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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04964336
Recruitment Status : Recruiting
First Posted : July 16, 2021
Last Update Posted : July 16, 2021
Information provided by (Responsible Party):
Andreas Lossius, 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.

Condition or disease Intervention/treatment
Multiple Sclerosis Other: Analysis of B cells

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: Decoding the B Cell Response in Multiple Sclerosis
Actual Study Start Date : February 5, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Multiple sclerosis
Patients with relapsing-remitting multiple sclerosis
Other: Analysis of B cells
B cells from blood and cerebrospinal fluid will be analyzed using RNA-seq

Primary Outcome Measures :
  1. The transcriptome of B cells from blood and cerebrospinal fluid [ Time Frame: 1 day (subject inclusion) ]
  2. The immunglobulin receptors of B cells from blood and cerebrospinal fluid [ Time Frame: 1 day (subject inclusion) ]

Biospecimen Retention:   Samples With DNA
Blood and cerebrospinal fluid

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients under diagnostic work-up for multiple sclerosis.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04964336

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Contact: Andreas Lossius, MD, PhD +47 93068515

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Akershus University Hospital Recruiting
Lørenskog, Norway
Contact: Trygve Holmøy, MD, PhD    +4767960000   
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Pål Berg-Hansen    +47 22118080   
Sponsors and Collaborators
University of Oslo
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Principal Investigator: Andreas Lossius University of Oslo
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Responsible Party: Andreas Lossius, Associate Professor, University of Oslo Identifier: NCT04964336    
Other Study ID Numbers: 314376 - FORSKER20
First Posted: July 16, 2021    Key Record Dates
Last Update Posted: July 16, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases