Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorWayne State University
About this trial
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)..
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Observation of Ocrelizumab as Treatment in RRMS Patients
Other interventionIt 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: African Americans with RRMS1 intervention
Group B: Caucasian American with RRMS1 intervention
Trial outcomes
Primary outcomes
1
Magnetic Resonance Imaging (MRI) with contrast
Approximately a 1 hour MRI with contrast (administered via IV)
Time frame
Change in MRI at BL, Month 6, Month 12, and Month 242
Optical Coherence Tomography Angiography (OCTA)
Eye scan with contrast (administered via IV)
Time frame
Change in OCTA at BL, Month 12, and Month 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov