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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04458688
• Other study ID #: ML41569
• Status: Recruiting
• Start date: November 20, 2021
• Est. completion date: December 2030

Study information

• Verified date: June 2022
• Source: Wayne State University
• Contact: Zahid Latif
• Phone: 3139660473
• Email: zahidlatif[@]wayne.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2030
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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.

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Optical Coherence Tomography Angiography (OCTA)	Eye scan with contrast (administered via IV)	Change in OCTA at BL, Month 12, and Month 24