Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

January 25, 2021 updated by: Howard L Weiner, Brigham and Women's Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

161

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monocyte Transcriptome Profiling
Time Frame: 12 months
Changes in messenger ribonucleic acid (mRNA) expression
12 months
Antigen microarrays
Time Frame: 12 months
Changes in serum autoantibody immune signatures
12 months
Serum microRNA profiles
Time Frame: 12 months
Changes in serum microRNA expression
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Collaborators

Genentech, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 20, 2017

Primary Completion (ACTUAL)

December 20, 2019

Study Completion (ACTUAL)

December 20, 2019

Study Registration Dates

First Submitted

May 1, 2017

First Submitted That Met QC Criteria

May 1, 2017

First Posted (ACTUAL)

May 3, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML39789

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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