Examining the effects of ocrelizumab in African American and Caucasian patients with relapsing multiple sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effects of ocrelizumab on the disease course of relapsing multiple sclerosis (RMS) in African American patients compared to Caucasian patients. Utilizing advanced imaging techniques such as magnetic resonance imaging (MRI) and optical coherence tomography angiography (OCTA), the study aims to assess differences in disease progression and severity. A total of 86 patients will be recruited, including 40 African Americans and 40 Caucasians, matched by age, sex, disease duration, and disability. Participants will have already chosen ocrelizumab as their disease-modifying therapy prior to enrollment and will attend five visits over six months.

Why it matters

Who can join: the full rules

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.

Where it's running

• Wayne State University
  Detroit, Michigan, United States Recruiting

Study contacts

• Principal investigator: Evanthia Bernitsas, MD — Wayne State University
• Study coordinator: Zahid Latif
• Email: zahidlatif@wayne.edu
• Phone: 3139660473

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.