Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
CONTACT
Lead
Genentech, Inc.
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
