This study will evaluate the effectiveness and safety of ocrelizumab in early stage relapsing-remitting multiple sclerosis (RRMS) patients.
Conditions
Interventions
Ocrelizumab (Ocrevus) - recombinant humanized anti-human monoclonal antibody
Sponsors
F. HOFFMANN-LA ROCHE LTD
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: • Signed informed consent form • Able to comply with the study protocol, in the investigator’s judgment • Age 18 - 55 years, inclusive • Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria (Polman et al. 2011) • Have a length of disease duration, from first documented clinical attack consistent with MS disease of = 3 years • Within the last 12 months: One or more clinically reported relapse(s) OR One or more signs of MRI activity • EDSS of 0.0 to 3.5 inclusive, at screening • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmenopausal state (? 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The following are acceptable contraceptive methods: progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action, male or female condom with or without spermicide, and cap, diaphragm, or sponge with spermicide. A combination of male condom with cap, diaphragm, or sponge with spermicide (double-barrier methods) is considered acceptable.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: • Secondary progressive multiple sclerosis progressive relapsing MS • Inability to complete an MRI (contraindications for MRI include but are not restricted to pacemaker, cochlear implants, presence of foreign substances in the eye, intracranial vascular clips, surgery within 6 weeks of entry into the study, coronary stent implanted within 8 weeks prior to the time of the intended MRI, claustrophobia, weight>140 kg, etc.) • Known presence of other neurological disorders, including but not limited to, the following: - History of ischemic cerebrovascular disorders (e.g., stroke, transient ischemic attack) or ischemia of the spinal cord - History or known presence of CNS or spinal cord tumor (e.g., meningioma, glioma) - History or known presence of potential metabolic causes of myelopathy (e.g., untreated vitamin B12 deficiency) - History or known presence of infectious causes of myelopathy (e.g., syphilis, Lyme disease, human T-lymphotropic virus 1 [HTLV-1], herpes zoster myelopathy) - History of genetically inherited progressive CNS degenerative disorder (e.g., hereditary paraparesis; MELAS [mitochondrial myopathy, encephalopathy, lactic acidosis, stroke] syndrome) - Neuromyelitis optica - History or known presence of systemic autoimmune disorders potentially causing progressive neurologic disease (e.g., lupus, anti-phospholipid antibody syndrome, Sjogren’s syndrome, Behçet’s disease, sarcoidosis) - History of severe, clinically significant brain or spinal cord trauma (e.g., cerebral contusion, spinal cord compression) UExclusions Related to General Health • Pregnancy or lactation • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study • History or currently active primary or secondary immunodeficiency • Lack of peripheral venous access • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies • Significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study • Congestive heart failure (New York Heart Association [NYHA] III or IV functional severity) • Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with intravenous (IV) antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening. Note: Active infections should be treated and effectively controlled before possible inclusion in the study • History of major opportunistic infections (i.e. cryptococcosis, Pneumocystis pneumonia, progressive multifocal leukoencephalopathy [PML]) • History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus [HIV], syphilis, tuberculosis [TB]) • History of malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins. • History of alcohol or drug abuse within 24 weeks prior to baseline • History or laboratory evidence of coagulation disorders UExclusions Related to Medications • Received any prior approved DMT with a
Outcome results
None listed