Ocrelizumab given under the skin after switching from another anti-CD20 therapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants with relapsing or primary progressive MS who are transitioning from another anti-CD20 therapy will receive subcutaneous ocrelizumab with recombinant human hyaluronidase. The trial will look at imaging biomarkers, patient outcomes, safety, tolerability, and treatment satisfaction. It is a Phase 4 interventional study conducted at multiple sites in the United States. Eligible participants must have an EDSS of 0-6.5 and have previously received an anti-CD20 therapy such as ofatumumab SC, ublituximab-xiiy IV, or ocrelizumab IV.

Why it matters

Who can join: the full rules

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

Exclusion Criteria:

* Participants who have demonstrated suboptimal response to aCD20 therapy
* Discontinuing aCD20 therapy because of any of the following treatment emergent adverse events (TEAEs): 1) Grade ≥3 severe infusion-related reaction (IRRs) or injection reactions (IRs); 2) Recurrent Grade ≥3 infections, or the need for ≥2 courses of antibiotics in the 12 months prior to screening, if the investigator believes infection is related to therapy
* Participants with contraindication to Gd+ and participants who for any reason cannot tolerate MRI procedure
* Known presence of active, recurrent, or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, human papillomavirus \[HPV\], tuberculosis \[TB\])
* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
* Known presence of neurologic disorders that may interfere with the diagnosis of RMS or PPMS
* Any concomitant disease that may require treatment with systemic corticosteroids (e.g., mineralocorticoids and glucocorticoids) or immunosuppressants during the study
* Known allergy or hypersensitivity to ocrelizumab, rHuPH20, or excipients of the OCR SC formulation
* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
* Treatment with any live-attenuated vaccine within 6 weeks prior to baseline
* Treatment with any experimental procedures for RMS or PPMS (e.g., treatment for chronic cerebrospinal venous insufficiency)
* Previous treatment with cladribine, atacicept, alemtuzumab or mitoxantrone
* Positive hepatitis B virus (HBV) and hepatitis C virus (HCV) antibody test at screening

Other protocol defined inclusion and exclusion criteria may apply.

Where it's running

• Alabama Neurology Associates
  Birmingham, Alabama, United States Recruiting
• Clinical Endpoints, LLC
  Scottsdale, Arizona, United States Recruiting
• Advanced Neurology of Colorado, LLC
  Fort Collins, Colorado, United States Recruiting
• Neurology Associates, PA
  Maitland, Florida, United States Recruiting
• Atlanta Neuroscience Institute
  Atlanta, Georgia, United States Recruiting
• Savannah Neurology Specialists,PC
  Savannah, Georgia, United States Recruiting

Study contacts

• Study coordinator: Reference Study ID Number: ML46740 https://forpatients.roche.com/ No attachments to email below.
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S.)

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.