Multiple Sclerosis Clinical Trial

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

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.

View Eligibility Criteria

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

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

179

Study ID:

NCT04377555

Recruitment Status:

Active, not recruiting

Sponsor:

Genentech, Inc.

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There are 31 Locations for this study

See Locations Near You

Barrow Neurological Institute
Phoenix Arizona, 85013, United States
Center for Neurology and Spine - Phoenix - Hunt - PPDS
Phoenix Arizona, 85032, United States
USC Keck School Of Medicine
Los Angeles California, 90033, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
Baptist Neurology - Beaches
Jacksonville Beach Florida, 32250, United States
University of Miami Miller School of Medicine
Miami Florida, 33136, United States
Shepherd Center Inc.
Atlanta Georgia, 30309, United States
Atlanta Neuroscience Institute
Atlanta Georgia, 30327, United States
Rush University Medical Center
Chicago Illinois, 60612, United States
Josephson Wallack Munshower Neurology PC
Indianapolis Indiana, 46256, United States
University of Maryland Medical Center; Department of Neurology
Baltimore Maryland, 21201, United States
Johns Hopkins Hospital; Neurology
Baltimore Maryland, 21205, United States
Wayne State University; Department of Neurology
Detroit Michigan, 48201, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Hackensack University Medical Center
Hackensack New Jersey, 07601, United States
Weill Cornell Medical College
New York New York, 10065, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
Guilford Neurologic Associates
Greensboro North Carolina, 27401, United States
UC Health, LLC.
Cincinnati Ohio, 45219, United States
Jefferson University Hospitals, Thomas Jefferson University
Philadelphia Pennsylvania, 19107, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37212, United States
University of Texas Southwestern Medical Center
Dallas Texas, 75390, United States
Baylor College of Medicine Medical Center
Houston Texas, 77030, United States
North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
Plano Texas, 75024, United States
Multiple Sclerosis Center of Tidewater
Norfolk Virginia, 23502, United States
Swedish Neuroscience Institute
Seattle Washington, 98122, United States
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Milwaukee Wisconsin, 53215, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Aga Khan University Hospital
Nairobi , 00100, Kenya
Centro Internacional De Mercadeo
Guaynabo , 969, Puerto Rico

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 4

Estimated Enrollment:

179

Study ID:

NCT04377555

Recruitment Status:

Active, not recruiting

Sponsor:


Genentech, Inc.

How clear is this clinincal trial information?

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