NCT04458688 · Wayne State University
Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
What this study 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)..
View original scientific description
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 participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- History of kidney or liver insufficiency.
- History of malignancy.
Where
- Detroit, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 6, 2022 · Source of record for eligibility and locations