Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03138525
• Collaborator: Genentech, Inc. (Industry)
• Enrollment: 161
• Location: 1
• Actual Duration (Months): 30
• Patients Per Site Per Month: 5.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis; Healthy	Other: Blood sampling (MS); Other: Blood sampling (controls)

Study Design

• Study Type: Observational
• Actual Enrollment: 161 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis
• Actual Study Start Date: Jun 20, 2017
• Actual Primary Completion Date: Dec 20, 2019
• Actual Study Completion Date: Dec 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Multiple Sclerosis Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab	Other: Blood sampling (MS); 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	Other: Blood sampling (controls); Blood samples will be collected once at enrollment.

Outcome Measures

Primary Outcome Measures

1. Monocyte Transcriptome Profiling [12 months]

   Changes in messenger ribonucleic acid (mRNA) expression

2. Antigen microarrays [12 months]

   Changes in serum autoantibody immune signatures

3. Serum microRNA profiles [12 months]

   Changes in serum microRNA expression

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts 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

Exclusion Criteria - Healthy Controls:

• MS

• First-degree relatives with MS

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital
• Genentech, Inc.

Investigators

• Principal Investigator: Howard L Weiner, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Howard L Weiner, Director, Partners Multiple Sclerosis Center; Co-Director, Ann Romney Center for Neurologic Diseases, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT03138525
• Other Study ID Numbers: ML39789
• First Posted: May 3, 2017
• Last Update Posted: Jan 27, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Multiple Sclerosis; Sclerosis

Study Results

No Results Posted as of Jan 27, 2021