Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
- Registration Number
- NCT04377555
- Lead Sponsor
- Genentech, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 179
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All Participants Ocrelizumab Main study participants will be evaluated at baseline, monitored and followed for a 1 year period with the option to participate in a 1 year extension. Participants in the CSF substudy will be followed for two years and will receive two additional doses of 600 mg ocrelizumab at Weeks 48 and 72.
- Primary Outcome Measures
Name Time Method Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment 48 Weeks A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain magnetic resonance imaging (MRI)
- Secondary Outcome Measures
Name Time Method Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 Week 48 Annualized relapse rate at week 48 Week 48 Time to protocol-defined event Week 48 A protocol-defined event is the occurrence of at least one of the following: a protocol-defined relapse; a 24-week Confirmed Disability Progression event; a T1 Gd-enhancing lesion or new and/or enlarging T2 lesion on brain MRI
Trial Locations
- Locations (32)
SUNY Upstate Medical Center
🇺🇸Syracuse, New York, United States
Neurology Specialists, Inc
🇺🇸Dayton, Ohio, United States
Centro Internacional De Mercadeo
🇵🇷Guaynabo, Puerto Rico
Keck School of Medicine of USC
🇺🇸Los Angeles, California, United States
Johns Hopkins University Neurology Research Office
🇺🇸Baltimore, Maryland, United States
Neurology Clinic - Cordova
🇺🇸Cordova, Tennessee, United States
Barrow Neurological Institute
🇺🇸Phoenix, Arizona, United States
Center for Neurology and Spine - Phoenix - Hunt - PPDS
🇺🇸Phoenix, Arizona, United States
Georgetown University Medical Center
🇺🇸Washington, District of Columbia, United States
Baptist Neurology - Beaches
🇺🇸Jacksonville Beach, Florida, United States
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
Shepherd Center Inc.
🇺🇸Atlanta, Georgia, United States
Atlanta Neuroscience Institute
🇺🇸Atlanta, Georgia, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Josephson Wallack Munshower Neurology PC
🇺🇸Indianapolis, Indiana, United States
University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Guilford Neurologic Associates
🇺🇸Greensboro, North Carolina, United States
Jefferson University Hospitals, Thomas Jefferson University
🇺🇸Philadelphia, Pennsylvania, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
🇺🇸Frisco, Texas, United States
Baylor College of Medicine Medical Center
🇺🇸Houston, Texas, United States
Multiple Sclerosis Center of Tidewater
🇺🇸Norfolk, Virginia, United States
Swedish Neuroscience Institute
🇺🇸Seattle, Washington, United States
Wheaton Franciscan Healthcare - St. Francis Outpatient Center
🇺🇸Milwaukee, Wisconsin, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
Aga Khan University Hospital
🇰🇪Nairobi, Kenya