Multiple Sclerosis, Relapsing Clinical Trial
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
| Verified date | May 2024 |
| Source | Genentech, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 179 |
| Est. completion date | December 29, 2025 |
| Est. primary completion date | December 29, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Kenya | Aga Khan University Hospital | Nairobi | |
| Puerto Rico | Centro Internacional De Mercadeo | Guaynabo | |
| United States | Atlanta Neuroscience Institute | Atlanta | Georgia |
| United States | Shepherd Center Inc. | Atlanta | Georgia |
| United States | Johns Hopkins Hospital; Neurology | Baltimore | Maryland |
| United States | University of Maryland Medical Center; Department of Neurology | Baltimore | Maryland |
| United States | Rush University Medical Center | Chicago | Illinois |
| United States | UC Health, LLC. | Cincinnati | Ohio |
| United States | Neurology Clinic PC | Cordova | Tennessee |
| United States | University of Texas Southwestern Medical Center | Dallas | Texas |
| United States | Wayne State University; Department of Neurology | Detroit | Michigan |
| United States | Guilford Neurologic Associates | Greensboro | North Carolina |
| United States | Hackensack University Medical Center | Hackensack | New Jersey |
| United States | Baylor College of Medicine Medical Center | Houston | Texas |
| United States | Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana |
| United States | Baptist Neurology - Beaches | Jacksonville Beach | Florida |
| United States | USC Keck School Of Medicine | Los Angeles | California |
| United States | University of Miami Miller School of Medicine | Miami | Florida |
| United States | Medical College of Wisconsin | Milwaukee | Wisconsin |
| United States | Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders | Milwaukee | Wisconsin |
| United States | Vanderbilt University Medical Center | Nashville | Tennessee |
| United States | Weill Cornell Medical College | New York | New York |
| United States | Multiple Sclerosis Center of Tidewater | Norfolk | Virginia |
| United States | Jefferson University Hospitals, Thomas Jefferson University | Philadelphia | Pennsylvania |
| United States | Barrow Neurological Institute | Phoenix | Arizona |
| United States | Center for Neurology and Spine - Phoenix - Hunt - PPDS | Phoenix | Arizona |
| United States | North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic | Plano | Texas |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Swedish Neuroscience Institute | Seattle | Washington |
| United States | SUNY Upstate Medical University | Syracuse | New York |
| United States | Georgetown University Medical Center | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Genentech, Inc. |
United States, Kenya, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Proportion of Participants Free of Any Protocol-defined Events During a 48-week Period on Treatment | 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) | 48 Weeks | |
| Secondary | Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 | Week 48 | ||
| Secondary | Time to protocol-defined event | 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 | Week 48 | |
| Secondary | Annualized relapse rate at week 48 | Week 48 |