Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

NCT03138525 | Completed

• 1 other identifier: ML39789
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Monocyte Transcriptome Profiling

  Changes in messenger ribonucleic acid (mRNA) expression

  12 months

• Antigen microarrays

  Changes in serum autoantibody immune signatures

  12 months

• Serum microRNA profiles

  Changes in serum microRNA expression

  12 months

Study Arms (2)

Multiple Sclerosis

Subjects with multiple sclerosis (MS) initiating treatment with ocrelizumab

Other: Blood sampling (MS)

Healthy

Healthy individuals serving as controls to the subjects with MS

Other: Blood sampling (controls)

Interventions

Blood sampling (MS) OTHER

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

Multiple Sclerosis

Blood sampling (controls) OTHER

Blood samples will be collected once at enrollment.

Healthy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Patients with relapsing form of MS starting treatment with ocrelizumab at Partners MS Center
• Healthy controls
• Ability to understand and sign informed consent

You may not qualify if:

• 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
• First-degree relatives with MS

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Genentech, Inc.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, and peripheral blood mononuclear cells.

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Howard L Weiner, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Partners Multiple Sclerosis Center; Co-Director, Ann Romney Center for Neurologic Diseases

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 3, 2017
• Study Start: June 20, 2017
• Primary Completion: December 20, 2019
• Study Completion: December 20, 2019
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)