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Completed

NCT Number: NCT03138525

Immune Profiling During Ocrelizumab Treatment in Multiple Sclerosis

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Healthy Immune System Diseases Nervous System Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sampling (MS)

Other

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

Blood sampling (controls)

Other

Blood samples will be collected once at enrollment.

Primary outcomes

  1. Monocyte Transcriptome Profiling

    Time frame: 12 months

    Changes in messenger ribonucleic acid (mRNA) expression

  2. Antigen microarrays

    Time frame: 12 months

    Changes in serum autoantibody immune signatures

  3. Serum microRNA profiles

    Time frame: 12 months

    Changes in serum microRNA expression

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Collaborators

  • Genentech, Inc.

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 3, 2017
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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