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

NCT04458688 | Recruiting FDA Drug

• 1 other identifier: ML41569
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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)..

Conditions

Multiple Sclerosis, Relapsing-Remitting

Keywords

multiple sclerosis; ocrelizumab; magnetic resonance imaging (MRI); optical coherence tomography angiography (OCTA)

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

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

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

Interventions

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.

Also known as: Observing Ocrelizumab Use

African Americans with RRMS; Caucasian American with RRMS

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.
• 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).
• Age 18 to 60 years old.
• Ethnicity: self-identified as African American or Caucasian.
• Clinically definite relapsing remitting multiple sclerosis (RRMS) per 2017 revised McDonald criteria.
• EDSS from 0 to 6 (inclusive) at baseline visit.
• Able to give informed consent.
• Able to have MRI scans.

You may not qualify if:

• Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.
• Failed 2 or more DMTs.
• Treatment with immunosuppressant agents, such as chemotherapeutic agents.
• Claustrophobia.
• Allergy to contrast.
• Significant medical problems that the PI determines will interfere with the conduct of the study.
• Relapse or use of corticosteroids within 30 days prior to baseline visit.
• Pregnancy.
• History of kidney or liver insufficiency.
• History of malignancy.

Sponsors & Collaborators

• Wayne State University: lead

Study Sites (1)

Wayne State University

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Evanthia Bernitsas, MD

  Wayne State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zahid Latif

CONTACT

3139660473; zahidlatif@wayne.edu

Kelly Jia

CONTACT

313-966-9407; xjia@med.wayne.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinipal Investigator

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: November 20, 2021
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 6, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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.
• Access Criteria: All data will be stored and shared in electronic case report form (eCRF) format.

Locations

US (1)