NCT04458688 Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
| NCT ID | NCT04458688 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wayne State University |
| Condition | Multiple Sclerosis, Relapsing-Remitting |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2021-11-20 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2021-11-20 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 resonance imaging (MRI) and optical coherence tomography angiography (OCT-A)..
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. 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). 3. Age 18 to 60 years old. 4. Ethnicity: self-identified as African American or Caucasian. 5. Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria. 6. EDSS from 0 to 6 (inclusive) at baseline visit. 7. Able to give informed consent. 8. Able to have MRI scans. Exclusion Criteria: 1. Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab. 2. Failed 2 or more DMTs. 3. Treatment with immunosuppressant agents, such as chemotherapeutic agents. 4. Claustrophobia. 5. Allergy to contrast. 6. Significant medical problems that the PI determines will interfere with the conduct of the study. 7. Relapse or use of corticosteroids within 30 days prior to baseline visit. 8. Pregnancy. 9. History of kidney or liver insufficiency. 10. History of malignancy.
Contact & Investigator
Evanthia Bernitsas, MD
PRINCIPAL INVESTIGATOR
Wayne State University
Frequently Asked Questions
Who can join the NCT04458688 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Multiple Sclerosis, Relapsing-Remitting. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04458688 currently recruiting?
Yes, NCT04458688 is actively recruiting participants. Contact the research team at zahidlatif@wayne.edu for enrollment information.
Where is the NCT04458688 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT04458688 clinical trial?
NCT04458688 is sponsored by Wayne State University. The principal investigator is Evanthia Bernitsas, MD at Wayne State University. The trial plans to enroll 80 participants.
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