Clinical trial NCT04377555: Prospective Study to Assess Disease Activity and Biomarkers in Minority Participants With Relapsing Multiple Sclerosis (RMS) After Initiation and During Treatment With Ocrelizumab
Official title: An Open-Label, Prospective, Single-arm, Multi-center Study to Assess Disease Activity and Biomarkers of Neuronal Damage in Minority Patients With Relapsing Multiple Sclerosis Receiving Treatment With Ocrelizumab
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Multiple Sclerosis, Relapsing
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2020-05-06
Enrollment: 179
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment
timeFrame: 48 Weeks
Secondary outcomes:
measure: Time to onset of 24 weeks confirmed disability progression (CDP) at week 48
timeFrame: Week 48
measure: Time to protocol-defined event
timeFrame: Week 48
measure: Annualized relapse rate at week 48
timeFrame: Week 48
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurological Institute
state: Arizona
city: Phoenix
country: United States
facility: Center for Neurology and Spine - Phoenix - Hunt - PPDS
state: Arizona
city: Los Angeles
country: United States
facility: Keck School of Medicine of USC
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Jacksonville Beach
country: United States
facility: Baptist Neurology - Beaches
state: Florida
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center Inc.
state: Georgia
city: Atlanta
country: United States
facility: Atlanta Neuroscience Institute
state: Georgia
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology PC
state: Indiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins University Neurology Research Office
state: Maryland
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical Center
state: New York
city: Greensboro
country: United States
facility: Guilford Neurologic Associates
state: North Carolina
city: Dayton
country: United States
facility: Neurology Specialists, Inc
state: Ohio
city: Philadelphia
country: United States
facility: Jefferson University Hospitals, Thomas Jefferson University
state: Pennsylvania
city: Cordova
country: United States
facility: Neurology Clinic - Cordova
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Frisco
country: United States
facility: North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Norfolk
country: United States
facility: Multiple Sclerosis Center of Tidewater
state: Virginia
city: Seattle
country: United States
facility: Swedish Neuroscience Institute
state: Washington
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Nairobi
country: Kenya
facility: Aga Khan University Hospital
city: Guaynabo
country: Puerto Rico
facility: Centro Internacional De Mercadeo
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: