Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

NCT ID: NCT03138525

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 161 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-20
• Study Completion Date: 2019-12-20

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.

Conditions

Multiple Sclerosis; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Multiple Sclerosis

Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab

Blood sampling (MS)

Intervention Type: OTHER

Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.

Healthy

Healthy individuals serving as controls to the subjects with MS

Blood sampling (controls)

Intervention Type: OTHER

Blood samples will be collected once at enrollment.

Interventions

Blood sampling (MS)

Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.

Intervention Type: OTHER

Blood sampling (controls)

Blood samples will be collected once at enrollment.

Intervention Type: OTHER

Eligibility 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

• 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

• MS
• First-degree relatives with MS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Howard L Weiner

Director, Partners Multiple Sclerosis Center; Co-Director, Ann Romney Center for Neurologic Diseases

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Howard L Weiner, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

ML39789

Identifier Type: -

Identifier Source: org_study_id