Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Healthy Clinical Trial

Official title:

Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03138525
• Other study ID #: ML39789
• Status: Completed
• Start date: June 20, 2017
• Est. completion date: December 20, 2019

Study information

• Verified date: January 2021
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: December 20, 2019
• Est. primary completion date: December 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Multiple Sclerosis
• Sclerosis

Intervention

Other:
• Blood sampling (MS)
Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.
• Blood sampling (controls)
Blood samples will be collected once at enrollment.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Monocyte Transcriptome Profiling	Changes in messenger ribonucleic acid (mRNA) expression	12 months
Primary	Antigen microarrays	Changes in serum autoantibody immune signatures	12 months
Primary	Serum microRNA profiles	Changes in serum microRNA expression	12 months