Recruiting

Ocrelizumab

Sponsor:

Wayne State University

Code:

NCT04458688

Conditions

Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Observation of Ocrelizumab as Treatment in RRMS Patients

Study Details

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

Study ID

NCT04458688

Start date

Nov 20, 2021

Status verified date

Jun, 2022

Completion date

Dec, 2030

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

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.

Primary outcome measure

  • Magnetic Resonance Imaging (MRI) with contrast [ Time Frame: Change in MRI at BL, Month 6, Month 12, and Month 24 ]
  • Optical Coherence Tomography Angiography (OCTA) [ Time Frame: Change in OCTA at BL, Month 12, and Month 24 ]

Central Contacts and Locations

Locations

Wayne State University

Recruiting

Detroit, Michigan, United States, 48201

Contacts

More Information

Sponsor

Wayne State University

Last update posted

Jun 6, 2022

Last verified

Jun, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wayne State University on 2022-06-06.