Multiple Sclerosis Clinical Trial

Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Summary

The purpose of this study is to assess effects of B cell depletion on the immune system in patients with relapsing forms of multiple sclerosis (MS) treated with ocrelizumab. This will be done by collecting blood from patients starting treatment with ocrelizumab before the first infusion and before the infusions at 6 and 12 months. The effects on the immune system will be assessed by performing transcriptome profiling of immune cells, measuring serum levels of microRNAs, and analyzing serum autoantibody immune signatures using antigen arrays. In addition, blood will be collected once from a group of healthy individuals to serve as controls.

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Eligibility Criteria

Inclusion Criteria:

Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
Healthy controls
Ability to understand and sign informed consent

Exclusion Criteria - All subjects:

Other concomitant autoimmune or inflammatory diseases
Ongoing treatment with other immunomodulatory medications
Previous treatment with rituximab, methotrexate, cyclophosphamide, mitoxantrone, mycophenolate mofetil, or alemtuzumab
Pregnancy or lactation
Hypersensitivity to ocrelizumab

Exclusion Criteria - Healthy Controls:

MS
First-degree relatives with MS

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

161

Study ID:

NCT03138525

Recruitment Status:

Completed

Sponsor:

Brigham and Women's Hospital

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There is 1 Location for this study

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Brigham and Women's Hospital
Boston Massachusetts, 02115, United States

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Estimated Enrollment:

161

Study ID:

NCT03138525

Recruitment Status:

Completed

Sponsor:


Brigham and Women's Hospital

How clear is this clinincal trial information?

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