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

Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study

This study is testing how well ocrelizumab works for treating relapsing multiple sclerosis in African American and Caucasian patients to see if there are any differences in how the disease progresses.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Wayne State University (Academic / other)
• Drugs / interventions: ocrelizumab, natalizumab, alemtuzumab, daclizumab
• Locations: 1 site (Detroit, Michigan)
• Trial ID: NCT04458688 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are African American or Caucasian adults aged 18 to 60 with clinically definite relapsing remitting multiple sclerosis who have chosen ocrelizumab as their treatment.

Not a fit: Patients who have previously failed two or more disease-modifying therapies or those with significant medical problems may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the differential effects of ocrelizumab based on ethnicity, potentially leading to more personalized treatment approaches for multiple sclerosis.

How similar studies have performed: While this study is novel in its specific focus on ethnic differences in response to ocrelizumab, previous studies have shown the effectiveness of ocrelizumab in treating relapsing multiple sclerosis.

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.

Where this trial is running

Detroit, Michigan

• Wayne State University — Detroit, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Evanthia Bernitsas, MD — Wayne State University
• Study coordinator: Zahid Latif

Conditions Multiple Sclerosis, Relapsing-Remitting; multiple sclerosis; ocrelizumab; magnetic resonance imaging; optical coherence tomography angiography