Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Multiple Sclerosis - Relapsing Remitting
- Type
- Observational
- Design
- Observational Model: Case-ControlTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 60 years
- Gender
- Both males and females
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 which results in demyelinating injury. Ocrelizumab was FDA approved in March 2017 for relapsing rem...
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 which results in demyelinating injury. Ocrelizumab was FDA approved in March 2017 for relapsing remitting (RRMS) and primary progressive multiple sclerosis (PPMS) by depleting B cells. It has shown to be effective in reducing the annualized relapse rate, decreasing disability progression, and reducing the number of new and active MRI brain lesions. Previous research studies have reported a more aggressive course in African Americans with MS, more lesions on the MRI scan, and more severe injury to layers of the eye (specifically in the retina) compared to Caucasians. This is a novel study investigating the effect of ocrelizumab in African American relapsing multiple sclerosis (RMS) patients compared to Caucasian RMS patients using imaging measures, specifically multimodal magnetic resonance imaging (MRI) and optical coherence tomography-angiography (OCTA). This is a non-drug intervention study; therefore, patients who are recruited will have already decided to make ocrelizumab their disease-modifying therapy before enrollment. The study will recruit 86 (including 6 potential screen fails) patients in total (40 African American patients and 40 Caucasian patients who are matched by age, sex, disease duration, and disease disability. The study will consist of 5 visits in six-month intervals across two years.
Tracking Information
- NCT #
- NCT04458688
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Evanthia Bernitsas, MD Wayne State University