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Recruiting NCT04458688

Investigating the Effect of Ocrelizumab in African Americans and Caucasians With Relapsing Multiple Sclerosis

— Observational Multiple Sclerosis, Relapsing-Remitting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observation of Ocrelizumab as Treatment in RRMS Patients.
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Relapsing-Remitting. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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)..

Detailed description

Multiple sclerosis (MS) is a disease of the central nervous system (CNS). Several lines of evidence suggest that MS is an autoimmune disease with both T and B-cell activity leading to CNS inflammation which results in demyelinating injury. Ocrelizumab was FDA approved in March 2017 for relapsing remitting (RRMS) and primary progressive multiple sclerosis (PPMS) by depleting B cells. It has shown to be effective in reducing the annualized relapse rate, decreasing disability progression, and reducing the number of new and active MRI brain lesions.

Previous research studies have reported a more aggressive course in African Americans with MS, more lesions on the MRI scan, and more severe injury to layers of the eye (specifically in the retina) compared to Caucasians.

This is a novel study investigating the effect of ocrelizumab in African American relapsing multiple sclerosis (RMS) patients compared to Caucasian RMS patients using imaging measures, specifically multimodal magnetic resonance imaging (MRI) and optical coherence tomography-angiography (OCTA). This is a non-drug intervention study; therefore, patients who are recruited will have already decided to make ocrelizumab their disease-modifying therapy before enrollment. The study will recruit 86 (including 6 potential screen fails) patients in total (40 African American patients and 40 Caucasian patients who are matched by age, sex, disease duration, and disease disability. The study will consist of 5 visits in six-month intervals across two years.

Interventions

  • Other Observation of Ocrelizumab as Treatment in RRMS Patients
    It 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.

Primary outcome measures

  • Magnetic Resonance Imaging (MRI) with contrast [Time frame: Change in MRI at BL, Month 6, Month 12, and Month 24]
  • Optical Coherence Tomography Angiography (OCTA) [Time frame: Change in OCTA at BL, Month 12, and Month 24]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Wayne State University — Detroit

Identifiers

NCT: NCT04458688 · ML41569

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗