Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Completed

• Conditions: Multiple Sclerosis; Healthy
• Interventions: Other: Blood sampling (controls); Other: Blood sampling (MS)

• Registration Number: NCT03138525
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-01
• Study First Submitted QC: 2017-05-01
• Study First Posted: 2017-05-03
• Study Start: 2017-06-20
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy	Blood sampling (controls)	Healthy individuals serving as controls to the subjects with MS
Multiple Sclerosis	Blood sampling (MS)	Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab

Primary Outcome Measures

Name	Time	Method
Antigen microarrays	12 months	Changes in serum autoantibody immune signatures
Monocyte Transcriptome Profiling	12 months	Changes in messenger ribonucleic acid (mRNA) expression
Serum microRNA profiles	12 months	Changes in serum microRNA expression

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States