Status:
COMPLETED
Mechanistic Study of Ocrevus
Lead Sponsor:
University of Michigan
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 25 2022
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT04459988
Start Date
July 1 2020
End Date
October 25 2022
Last Update
May 31 2024
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109