Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis, Healthy

In brief

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.

Key facts

Study ID

NCT03138525

Run by

Brigham and Women's Hospital

People needed

161

Starts

2017-06-20

Expected to finish

2019-12-20

Last updated by the study team

2021-01-27

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.