NCT04458688Recruiting
Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis: a Novel, Advanced Multimodal MRI and Optical Coherence Tomography-Angiography (OCTA) Study
Source: ClinicalTrials.gov · Last updated 6 Jun 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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)..
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 80 (estimated)
- First submitted
- 30 Jun 2020
- Start date
- 20 Nov 2021
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- Wayne State University
- Diseases
- Multiple sclerosis
- NCT number
- NCT04458688
What you commit to
- Study type: Observational
- Planned participants: 80
- From 20 Nov 2021 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Treatment with another monoclonal antibody, including but not limited to natalizumab, alemtuzumab, daclizumab.
- Treatment with immunosuppressant agents, such as chemotherapeutic agents.
- Relapse or use of corticosteroids within 30 days prior to baseline visit.
Other illness
- Allergy to contrast.
- History of kidney or liver insufficiency.
- History of malignancy.
Other
- Failed 2 or more DMTs.
- Claustrophobia.
- Significant medical problems that the PI determines will interfere with the conduct of the study.
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wayne State University Coordinator of this site? Confirm its status | Detroit | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.