Investigating the Effect of Ocrelizumab in African Americans and Caucasians 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

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)..

Study Overview

• Status: Recruiting
• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Intervention / Treatment: Other: Observation of Ocrelizumab as Treatment in RRMS Patients

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Zahid Latif; Phone Number: 3139660473; Email: zahidlatif@wayne.edu

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Recruiting
      • Wayne State University
      • Contact: Zahid Latif; Phone Number: 313-966-0473; Email: zahidlatif@wayne.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: 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.; Other Names: Observing Ocrelizumab Use
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.	Other: 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.; Other Names: Observing Ocrelizumab Use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Wayne State University
• Investigators: Principal Investigator: Evanthia Bernitsas, MD, Wayne State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 20, 2021
• Primary Completion (ANTICIPATED): July 1, 2025
• Study Completion (ANTICIPATED): December 1, 2030

Study Registration Dates

• First Submitted: June 30, 2020
• First Submitted That Met QC Criteria: July 2, 2020
• First Posted (ACTUAL): July 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 6, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: multiple sclerosis; ocrelizumab; magnetic resonance imaging (MRI); optical coherence tomography angiography (OCTA)
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Physiological Effects of Drugs; Immunologic Factors; Ocrelizumab
• Other Study ID Numbers: ML41569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will be available for the duration of the study and up to 15 years after the last patient has completed the study.
• IPD Sharing Access Criteria: All data will be stored and shared in electronic case report form (eCRF) format.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No