Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis

NCT ID: NCT04458688

Last Updated: 2022-06-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-20
• Study Completion Date: 2030-12-31

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)..

Detailed 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 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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Observation of Ocrelizumab as Treatment in RRMS Patients

Intervention Type: 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.

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.

Observation of Ocrelizumab as Treatment in RRMS Patients

Intervention Type: 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.

Interventions

Observation of Ocrelizumab as Treatment in RRMS Patients

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.

Intervention Type: OTHER

Other Intervention Names

Observing Ocrelizumab Use

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wayne State University

OTHER

Sponsor Role: lead

Responsible Party

Evanthia Bernitsas, MD

Prinipal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Evanthia Bernitsas, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University

Locations

Wayne State University

Detroit, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Zahid Latif

Role: CONTACT

zahidlatif@wayne.edu

3139660473

Kelly Jia

Role: CONTACT

xjia@med.wayne.edu

313-966-9407

Facility Contacts

Zahid Latif

Role: primary

zahidlatif@wayne.edu

313-966-0473

Kelly Jia

Role: backup

xjia@med.wayne.edu

313-966-9407

Other Identifiers

ML41569

Identifier Type: -

Identifier Source: org_study_id