Clinical trial NCT04459988: Mechanistic Study of Ocrevus
Official title: Enhanced Regulatory Functions of Bregs With Ocrelizumab in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Ocrevus
B cell
T cell
cytokines
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit 25 MS patients (Group 1; include 5-10 PPMS and 15-20 RRMS). Meanwhile, 10 healthy controls (Group 2; HCs) will be recruited to establish baseline immune cell profiles. The patients and healthy controls will be recruited at the University of Michigan Neurology Clinic.

Brief summary: The purpose of this study is to investigate the immune cell and other factor changes with Ocrevus in Multiple Sclerosis (MS) patients. Researchers will recruit 35 participants for this study. Patients will be enrolled from the Multiple Sclerosis Center at the University of Michigan Health System in Ann Arbor. The goal of the study is to understand the role of regulatory B cell, T cell and other factors in mediating the therapeutic effects of Ocrevus.


Eligibility criteria: Inclusion Criteria:

Patients with MS either with relapsing or primary progressive course; who are newly starting on ocrelizumab (Ocrevus) at the time of enrollment

OR

Healthy controls who do not have a significant medical conditions such as cancer, chronic infection, or autoimmune disease, have not taken steroids in the past 2 months, and who are not on an immune suppressant medication.

* Ability to give informed consent
* Willing to have blood drawn as scheduled in the protocol
* Willing and able to complete all procedures and evaluations related to the study

Exclusion Criteria:

* Medical or psychiatric conditions that may affect the patient's ability to give informed consent
* Has received an experimental drug within 30 days of enrollment
* Concomitant other disease modifying medications (such as Rebif, Betaseron, Avonex, Copaxone, Gilenya, Tecfidera, Aubagio, Mayzent, Mavenclad, Alemtuzumab, methotrexate, azathioprine, Novantrone, cyclophosphamide, cyclosporine, Tysabri, Rituxan, Ocrevus, etc.)
* Has any contraindication to high-dose immunotherapy, including pregnancy, trying to become pregnant, or breast feeding during the study
* Active hepatitis B virus infection
* History of life-threatening infusion reaction to Rituxan or Ocrevus
* Chronic infection or any severe acute infection within 3 months prior to screening

Primary outcomes:
measure: Change in frequency of regulatory B cells
timeFrame: From baseline to 24 months
Secondary outcomes:
measure: Change in frequency of T cell subtypes
timeFrame: From baseline to 24 months
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yang Mao-Draayer, MD/PHD
role: PRINCIPAL_INVESTIGATOR
References: