A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eligible to receive ocrelizumab per the United States Package Insert (USPI)
Able to comply with the study protocol, in the investigator's judgment
Age 18-55 years, inclusive
Have a diagnosis of PPMS or RMS, confirmed per the revised 2017 McDonald criteria
Expanded Disability Status Scale (EDSS) score of 0 to 6.5, inclusive
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \<1% per year during the treatment period and for at least 6 months after the last dose of study treatment (per the USPI)
You may not be if
Experienced serious IRR(s)
History of life-threatening infusion reaction to ocrelizumab
Known presence of other neurological disorders
Pregnancy or lactation, or intention to become pregnant during the study
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 (including cardiac arrhythmia), pulmonary (including obstructive pulmonary disease), renal, hepatic, endocrine, and gastrointestinal or any other significant disease that may preclude patient from participating in the study
Congestive heart failure
Known active bacterial, viral, fungal, mycobacterial infection or other infection or any severe episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit
History of or currently active primary or secondary immunodeficiency
History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
History of recurrent aspiration pneumonia requiring antibiotic therapy
History of malignancy, including solid tumors and hematological malignancies,except basal cell, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been excised with clear margins
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
History of alcohol or drug abuse within 24 weeks prior to enrollment
Receipt of a live vaccine within 6 weeks prior to enrollment
Systemic corticosteroid therapy within 4 weeks prior to enrollment
Contraindications to or intolerance of oral or IV corticosteroids, including IV methylprednisolone (or equivalent steroid) administered according to the country label
Treatment with alemtuzumab
Treatment with a B-cell targeted therapies other than ocrelizumab
Treatment with a drug that is experimental
Abnormal laboratory results per local laboratory standards and investigator assessment
Clareo Health | A Study to Evaluate the Safety of Administering Ocrelizumab Per a Shorter Infusion Protocol in Participants With Primary Progressive Multiple Sclerosis (PPMS) and Relapsing Multiple Sclerosis (RMS)
