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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of 24 weeks confirmed disability progression (CDP) at week 48 | Week 48 | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barrow Neurological Institute | Phoenix | Arizona | 85013 | United States | ||
| Keck School of Medicine of USC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37356256 | Derived | Williams MJ, Okai AF, Cross AH, Monson NL, Vartanian T, Thrower BW, Reder AT, English JB, Wu GF, Bernitsas E, Yap S, Ndrio J, Pei J, Mowry EM, Magrini F, Acosta J, Amezcua L; CHIMES investigators. Demographics and baseline disease characteristics of Black and Hispanic patients with multiple sclerosis in the open-label, single-arm, multicenter, phase IV CHIMES trial. Mult Scler Relat Disord. 2023 Aug;76:104794. doi: 10.1016/j.msard.2023.104794. Epub 2023 Jun 9. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| Week 48 |
| Annualized relapse rate at week 48 | Week 48 |
| Los Angeles |
| California |
| 90033-5315 |
| United States |
| Georgetown University Medical Center | Washington D.C. | 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 | 60612-3244 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Josephson Wallack Munshower Neurology PC | Indianapolis | Indiana | 46256 | United States |
| University of Maryland Medical Center | Baltimore | Maryland | 21201-1642 | United States |
| Johns Hopkins University Neurology Research Office | Baltimore | Maryland | 21287 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Hackensack University Medical Center | Paramus | New Jersey | 07652 | United States |
| SUNY Upstate Medical Center | Syracuse | New York | 13210 | United States |
| Guilford Neurologic Research Partners, LLC | Greensboro | North Carolina | 27401 | United States |
| Jefferson University Hospitals, Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Neurology Clinic - Cordova | Cordova | Tennessee | 38018 | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| North Texas Institute of Neurology and Headache NextStage Clinical Research Clinic | Frisco | Texas | 75034 | United States |
| Baylor College of Medicine Medical Center | Houston | Texas | 77030 | United States |
| Multiple Sclerosis Center of Tidewater | Norfolk | Virginia | 23502 | United States |
| Wheaton Franciscan Healthcare - St. Francis Outpatient Center | Milwaukee | Wisconsin | 53215 | United States |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| The Aga Khan University-Kenya. | Nairobi | 00100 | Kenya |
| Centro Internacional De Mercadeo | Guaynabo | 969 | Puerto Rico |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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