Studying ocrelizumab effects in relapsing multiple sclerosis in two racial groups
Observes ocrelizumab-treated adults with relapsing multiple sclerosis using brain and eye scans.
Key facts
- Who runs it
- Wayne State University
- Where
- Detroit, United StatesSee the site
- Trial code
- Registry title
- Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 20 Nov 2021
- Expected to end
- Dec 2030
- Type of study
- Observational, 2 groups
- Treatments tested
- Observation of Ocrelizumab as Treatment in RRMS Patients
- Record updated
- 6 June 2022
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for African American or Caucasian adults with relapsing remitting multiple sclerosis who are starting ocrelizumab as their standard treatment.
- Age
- 18 to 60 years old
- Sex
- All sexes can join.
- Disease stage
- Clinically definite relapsing remitting multiple sclerosis (2017 revised McDonald criteria), with an EDSS score from 0 to 6 at the baseline visit.
- Earlier treatment
- People can be new to treatment, or have had a poor response to no more than one disease modifying therapy after at least 6 months of use. Failing 2 or more such therapies, or other monoclonal antibodies or immunosuppressants, rules a person out.
Main reasons for not taking part
- Treatment with another monoclonal antibody (such as natalizumab, alemtuzumab, daclizumab) or an immunosuppressant
- Failed 2 or more disease modifying therapies
- Relapse or use of corticosteroids within 30 days before the baseline visit
- Pregnancy
- History of kidney or liver insufficiency or of cancer
The registry criteria, word for word
Show all 18 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Allergy to contrast
- History of kidney or liver insufficiency
- History of malignancy
- Failed 2 or more DMTs
- Claustrophobia
- Significant medical problems that the PI determines will interfere with the conduct of the study
- Pregnancy
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Where in United States
- Wayne State UniversityDetroit, United StatesContact: Zahid LatifTaking people
About the trial
What the trial wants to find out
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)..
The 2 groups in the trial
- 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.
Treatment: Observation of Ocrelizumab as Treatment in RRMS Patients
- 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.
Treatment: Observation of Ocrelizumab as Treatment in RRMS Patients
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Plain-language title
- Studying ocrelizumab effects in relapsing multiple sclerosis in two racial groupsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT04458688, who can take part
- Record updated
- 6 June 2022