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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)..
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| African Americans with RRMS | Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as African American. |
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| Caucasian American with RRMS | Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: Self-described as Caucasian American. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation of Ocrelizumab as Treatment in RRMS Patients | Other | It is decided by the patient and their physician to begin taking ocrelizumab PRIOR to study enrollment. The study is only observing the effects of ocrelizumab as a pre-decided treatment option for a patient's MS. |
| Measure | Description | Time Frame |
|---|---|---|
| Magnetic Resonance Imaging (MRI) with contrast | Approximately a 1 hour MRI with contrast (administered via IV) | Change in MRI at BL, Month 6, Month 12, and Month 24 |
| Optical Coherence Tomography Angiography (OCTA) | Eye scan with contrast (administered via IV) | Change in OCTA at BL, Month 12, and Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants who are diagnosed with relapsing multiple sclerosis and who have chosen to start or recently started using ocrelizumab as their disease modifying therapy. Age range: 18 to 60 years old. Ethnicity: self-described as African American or Caucasian.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zahid Latif | Contact | 3139660473 | zahidlatif@wayne.edu | |
| Kelly Jia | Contact | 313-966-9407 | xjia@med.wayne.edu |
| Name | Affiliation | Role |
|---|---|---|
| Evanthia Bernitsas, MD | Wayne State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University | Recruiting | Detroit | Michigan | 48201 | United States |
Study protocol, ICFs, study reports, statistical analysis plans, secure CRFs, and results will be shared with Roche/Genentech Inc. All patient data will have a unique number/digit code when sent to protect patient identity.
Data will be available for the duration of the study and up to 15 years after the last patient has completed the study.
All data will be stored and shared in electronic case report form (eCRF) format.
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| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |