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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Georgia
Atlanta Neuroscience Institute
RECRUITING
Atlanta
Tennessee
Neurology Clinic PC
RECRUITING
Cordova
Other Locations
Puerto Rico
Caribbean Center for Clinical Research
RECRUITING
Guaynabo
Contact Information
Primary
Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Backup
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Time Frame
Start Date: 2026-09-02
Estimated Completion Date: 2029-02-28
Participants
Target number of participants: 100
Treatments
Experimental: OCR SC
Participants will receive OCR SC, 920 milligrams (mg) at Day 1 and at Week 24.
Sponsors
Leads: Genentech, Inc.

This content was sourced from clinicaltrials.gov

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