Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
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 (Thompson et al. 2018) or the most current McDonald criteria at the time of study start
Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening
You may not be if
Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening
Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons
History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
Immunocompromised state
Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study
Lack of peripheral venous access
Previous treatment with cladribine, atacicept, and alemtuzumab
Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
Any previous history of transplantation or anti-rejection therapy
Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)
Clareo Health | A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)
