Status:
RECRUITING
Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
Lead Sponsor:
Wayne State University
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-60 years
Brief Summary
The investigators intend to examine the effects of ocrelizumab use in African American multiple sclerosis disease course compared to Caucasian disease course utilizing imaging measures with magnetic r...
Detailed Description
Multiple sclerosis (MS) is a disease of the central nervous system (CNS). Several lines of evidence suggest that MS is an autoimmune disease with both T and B-cell activity leading to CNS inflammation...
Eligibility Criteria
Inclusion
- Patients who have chosen to start ocrelizumab and for whom ocrelizumab is determined to be the most appropriate standard-of-care disease modifying therapy (DMT) by the treating neurologist.
- May be treatment naive, or had suboptimal response to no more than one DMT after an adequate course of treatment (defined as treatment duration of 6+ months).
- Age 18 to 60 years old.
- Ethnicity: self-identified as African American or Caucasian.
- Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.
- EDSS from 0 to 6 (inclusive) at baseline visit.
- Able to give informed consent.
- Able to have MRI scans.
Exclusion
- Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.
- Failed 2 or more DMTs.
- Treatment with immunosuppressant agents, such as chemotherapeutic agents.
- Claustrophobia.
- Allergy to contrast.
- Significant medical problems that the PI determines will interfere with the conduct of the study.
- Relapse or use of corticosteroids within 30 days prior to baseline visit.
- Pregnancy.
- History of kidney or liver insufficiency.
- History of malignancy.
Key Trial Info
Start Date :
November 20 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2030
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04458688
Start Date
November 20 2021
End Date
December 1 2030
Last Update
June 6 2022
Active Locations (1)
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1
Wayne State University
Detroit, Michigan, United States, 48201