A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Genentech, Inc.

Summary

The purpose of this study is to assess the imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction of ocrelizumab (OCR) combined with recombinant human hyaluronidase (rHuPH20) administered subcutaneously (SC) in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS) after switching from another anti-cluster of differentiation 20 (aCD20) therapy approved for RMS (ofatumumab SC, ublituximab-xiiy intravenous \[IV\], ocrelizumab IV) or PPMS (ocrelizumab IV).

Eligibility

Age range: 18–65 years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria * Documented Expanded Disability Status Scale (EDSS) score of 0-6.5, inclusive, at screening (or within 6 months of screening) * Participants discontinuing aCD20 therapy for reasons including, but not limited to, physician/participant preference, access to commercial drug (e.g., insurance coverage issues), or other logistical reasons (such as geographical relocation, travel, etc.) are eligible for this study * Prior treatment with ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV aCD20 therapy…

Interventions

Drug
OCR SC
Participants will receive OCR SC as per the schedule specified in the arm and the United States Prescribing Information (USPI).

Locations (3)

Atlanta Neuroscience Institute
Atlanta, Georgia
Neurology Clinic PC
Cordova, Tennessee
Caribbean Center for Clinical Research
Guaynabo

A Prospective, Multicenter, Single-arm Study of Ocrelizumab Administered Subcutaneously in Patients With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy

Summary

Eligibility

Interventions

Locations (3)

Compensation

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Details

Conditions