Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
Recruiting · NCT04458688 · Observational (researchers observe without assigning treatment) · Lead sponsor: Wayne State University
View the official record on ClinicalTrials.gov →Interventions studied
Observation of Ocrelizumab as Treatment in RRMS Patients
What this trial is about
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)..
Who can take part
Age range
18 Years to 60 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where it is running
1 location listed across 1 US state.
- Wayne State University - Detroit, Michigan, United States