Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
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
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 percent (%) per year during the treatment period and for at least 24 weeks after the last dose of study treatment or until their B-cells have repleted, whichever is longer
Diagnosis of RMS in accordance with the 2010 revised McDonald criteria
Expanded Disability Status Scale (EDSS) score of 0 to 5.5 points, inclusive, at Screening
Disease duration from the onset of multiple sclerosis symptoms less than (\<) 15 years in participants with an EDSS score greater than (\>) 5.0 at Screening
Either treatment-naive or receiving treatment with disease-modifying therapies, including prior use of interferon (IFN)-beta-1a (Avonex®, Rebif®), IFN-beta-1b (Betaseron®/Betaferon), or glatiramer acetate (Copaxone®).
At least one clinically documented relapse in the past year and/or at least one T1-weighted Gadolinium (Gd)-enhancing lesion in the past year and/or at least one new T2 lesion in the past year at the time of enrollment
Separate signed Informed Consent Form for the RMS Delayed Time to Start Control Arm (Arm 4)
Must be willing to remain on the same dose and regimen of current standard of care, or no treatment if treatment-naïve, for 12 weeks after study enrollment The treating and/or study physician must agree that the participant is eligible to remain on the same dose and regimen of their current standard of care at Screening, or to receive no treatment if the participant is treatment-naïve, for 12 weeks after study enrollment
Diagnosis of PPMS in accordance with the 2010 revised McDonald criteria
EDSS score of 3.0 - 6.5 points, inclusive, at Screening
Disease duration from the onset of multiple sclerosis symptoms \<10 years in participants with an EDSS at Screening less than or equal to (\</=) 5.0
Documented history of either elevated immunoglobulin G (IgG) Index or one or more IgG oligoclonal bands (OCBs) detected by isoelectric focusing
You may not be if
Diagnosis of secondary progressive multiple sclerosis without relapses for at least 1 year
History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus \[HIV\], syphilis, tuberculosis)
History of recurrent aspiration pneumonia requiring antibiotic therapy
History of cancer, including solid tumors and hematological malignancies (except basal cell, in situ squamous cell carcinomas of the skin, and in situ carcinoma of the cervix of the uterus that have been excised and resolved with documented clean margins on pathology)
History of or currently active primary or secondary immunodeficiency
History of coagulation disorders
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
History of alcohol or other drug abuse within 24 weeks prior to enrollment
Known presence or history of other neurologic disorders Significant, uncontrolled disease, such as cardiovascular (including cardiac arrhythmia), pulmonary (including chronic obstructive pulmonary disease), renal, hepatic, endocrine, gastrointestinal, or any other significant disease
Congestive heart failure (according to New York Heart Association III or IV functional severity)
Known active bacterial, viral, fungal, mycobacterial infection, or any major episode of infection requiring hospitalization or treatment with IV antibiotics
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
Contraindications or intolerance to oral or IV corticosteroids, including IV methylprednisolone, according to the country label
Contraindication for LP
Previous treatment with B cell-targeted therapies (such as rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Previous treatment with natalizumab/Tysabri®, alemtuzumab, anti-CD4 agents, cladribine, teriflunomide, cyclophosphamide, mitoxantrone, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, total body irradiation, or bone marrow transplantation
Treatment with fingolimod/Gilenya®, dimethyl fumarate/Tecfidera®, or similar treatment within 6 months prior to enrollment
Receipt of a live vaccine within 6 weeks prior to enrollment
Systemic corticosteroid therapy within 4 weeks prior to Baseline
Previous or concurrent treatment with any investigational agent or treatment with any experimental procedure for multiple sclerosis (such as treatment for chronic cerebrospinal venous insufficiency)
Certain laboratory abnormalities or findings at Screening
Inability to complete an MRI
Lack of peripheral venous access
Pregnant or lactating, or intending to become pregnant during the study
Diagnosis of PPMS or secondary progressive multiple sclerosis without relapses
Clareo Health | Study to Explore the Mechanism of Action of Ocrelizumab and B-Cell Biology in Participants With Relapsing Multiple Sclerosis (RMS) or Primary Progressive Multiple Sclerosis (PPMS)
