Healthy, Multiple Sclerosis
Conditions
Brief 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.
Interventions
OTHERBlood sampling (MS)
Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.
OTHERBlood sampling (controls)
Blood samples will be collected once at enrollment.
Sponsors
Genentech, Inc.
Brigham and Women's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocyte Transcriptome Profiling | 12 months | Changes in messenger ribonucleic acid (mRNA) expression |
| Antigen microarrays | 12 months | Changes in serum autoantibody immune signatures |
| Serum microRNA profiles | 12 months | Changes in serum microRNA expression |
Countries
United States
Outcome results
None listed