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Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab

NCT04377555

CompletedPhase 4

Sponsor: Genentech, Inc.

Conditions: Multiple Sclerosis, Relapsing

Interventions: Ocrelizumab

Countries: United States, Kenya, Puerto Rico

Open-label, prospective, single-arm, multi-center study to assess disease activity and biomarker of neuronal damage in minority patients (self-identified Black or African American (AA) and Hispanic/Latino (HA) patients with relapsing multiple sclerosis (RMS) receiving treatment with Ocrelizumab. The study plans to enroll approximately 150 participants (75 AA and 75 HA) with 50 participants enrolled in a CSF sub-study.

Eligibility overview

Sex: ALL

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Diagnosis of RMS with Expanded Disability Status Scale (EDSS) 0-5.5 at enrollment
* Participants who self-identify as Black or African American or Hispanic/Latino American
* Treatment-naïve or initiating first or second switch from receiving treatment with certain disease modifying therapies (DMTs) including interferon or glatiramer acetate or dimethyl fumarate (DMF); or siponimod; or fingolimod; or diroximel fumarate; or teriflunomide; or ozanimod; or natalizumab
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive methods during the treatment period and for 6 months after the final dose of ocrelizumab
* Neurologically stable for at least 30 days prior to randomization and baseline assessments

Exclusion Criteria:

* Diagnosis of secondary progressive MS without relapses for at least 1 year (nonactive or inactive SPMS)
* Primary Progressive Multiple Sclerosis (PPMS)
* Participants with contraindication to gadolinium based contrast agent for MRI and participants who cannot tolerate MRI procedure
* Infection Related
* Cancer Related
* Pregnant or lactating, or intending to become pregnant during the study
* Other Medical Conditions
* Known presence or history of other neurologic disorders
* Vaccinations: Receipt of a live vaccine, or attenuated, or inactivated / component vaccine within 6 weeks prior to first administration of ocrelizumab
* Laboratory: abnormalities or findings at screening
Locations (28)
  • Phoenix, Arizona, United States
  • Los Angeles, California, United States
  • Washington D.C., District of Columbia, United States
  • Jacksonville Beach, Florida, United States
  • Miami, Florida, United States
  • Atlanta, Georgia, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Baltimore, Maryland, United States
  • Baltimore, Maryland, United States
  • Detroit, Michigan, United States
  • St Louis, Missouri, United States
  • Paramus, New Jersey, United States
  • Syracuse, New York, United States
  • Greensboro, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Cordova, Tennessee, United States
  • Nashville, Tennessee, United States
  • Dallas, Texas, United States
  • Frisco, Texas, United States
  • Houston, Texas, United States
  • Norfolk, Virginia, United States
  • Milwaukee, Wisconsin, United States
  • Milwaukee, Wisconsin, United States
  • Nairobi, Kenya
  • Guaynabo, Puerto Rico