Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
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Details and patient eligibility
About
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.
Enrollment
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Volunteers
Inclusion and exclusion 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
Trial design
161 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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